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Nov 18, 2020
11/20
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CSPAN3
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is it at eua approval? is it when 10% of the population has been immunized for a particular start of the population that has been prioritized? is it when the bla is approved from a regulatory standpoint is the trigger point, that's the latest possible. so we're talking about a period of maybe two or three months which is currently which is what we project between the time between the eua and the bla. we always said that the eua was a pit stop on the trajectory to a bla and that's the case. so it will happen. it will have, therefore, an impact on our capacity to have controlled data. but it will not impact our capacity to continue to have data. we just will not have the control group anymore as they would be immunized. there are strategies to extract information from that. at that stage, we'll also potentially have impact on recruiting subjects in other clinical trials. now, i do want to make a point here and a plea, frankly, which is we now know that vaccination is possible. not only it's possible, but it's
is it at eua approval? is it when 10% of the population has been immunized for a particular start of the population that has been prioritized? is it when the bla is approved from a regulatory standpoint is the trigger point, that's the latest possible. so we're talking about a period of maybe two or three months which is currently which is what we project between the time between the eua and the bla. we always said that the eua was a pit stop on the trajectory to a bla and that's the case. so...
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Nov 19, 2020
11/20
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CSPAN
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eye 47
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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
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...
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Nov 14, 2020
11/20
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CSPAN
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eye 35
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them as soon as the fda applies the eua.e will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and the existing vaccine delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated pro rata by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely along with the cdc, the 64 jurisdictions, and states to ensure a vaccine can safely and quickly get to those who need it first. and then we have plans to ensure that it spreads exponentially across our country and that no place is left without a vaccine. at the end of the day, our success is going to be judged by the availability of the vaccine as shots go in arms. it is the partnerships we have formed with the pharmaceutical companies like pfizer and moderna. distribution companies like mckesson, fedex, and ups. and pharmacies like cvs and walgreens that have agreed to do things differently, to think, how can we
them as soon as the fda applies the eua.e will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and the existing vaccine delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated pro rata by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely along with the cdc, the 64 jurisdictions, and states to ensure a vaccine can...
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Nov 13, 2020
11/20
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BLOOMBERG
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we will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and existing delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely with the cdc, the 64 jurisdictions and states, to ensure the vaccine can safely get to those who needed first. then we have plans to ensure that it spreads exponentially across our country and that no place is left without a vaccine. at the end of the day, our success is going to be judged by the available -- availability of the vaccine. it is the partnerships we have formed with pharmaceutical companies like pfizer and moderna, distribution companies like fedex and ups, and pharmacies like cvs and walgreens that have agreed to do things differently to think, how can we get this to the american people? we will be successful because of this all of america approach. this collab
we will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and existing delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely with the cdc, the 64 jurisdictions and states, to ensure the vaccine can safely get to those who needed first. then we have plans to ensure...
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Nov 24, 2020
11/20
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CSPAN
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eye 68
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long-term, -- that is the reason why the fda appropriately said we do not want to think in terms eua until we get 60 days beyond when 50% of the people in the trial have gotten their last dose. that may seem strange to people waythat is a very prudent to out rule the overwhelming majority of serious effects. they will still be looking a year or two later, but the full go of things that will happen have already been looked at i by that 60 day wait. , the career scientist to been doing this in their entire vaccineor vaccine after know what they are doing and that's why they made that safety clause in the eua. can you walk>> through the accuracy of current tests? people are wondering what to do, which test to take. dr. fauci: there are number of tests, three general types. a pcr, a molecular test. tests for a component of the virus which is in antigen test and test for the antibody to see if you actually have been infected and exposed. if you want to find out if a person absolutely is infected or not, for example if you're doing identification and isolation tracing, you want to know if
long-term, -- that is the reason why the fda appropriately said we do not want to think in terms eua until we get 60 days beyond when 50% of the people in the trial have gotten their last dose. that may seem strange to people waythat is a very prudent to out rule the overwhelming majority of serious effects. they will still be looking a year or two later, but the full go of things that will happen have already been looked at i by that 60 day wait. , the career scientist to been doing this in...
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Nov 24, 2020
11/20
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CSPAN
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eye 28
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that's why they made the safety clause in the eua. robert: can you walk through the accuracy of current tests? people are wondering this week what to do, which test to take. dr. fauci: there are a number of tests, three general types. tests for the virus itself, it is a pcr, a molecular test. tests for a component of the virus, which is an antigen test. and tests for the antibody to see if you have been infected and exposed. if you want to find out if a person absolutely is infected or not, for example if you are doing identification, isolation, contact tracing, someone has symptoms and you want to know if they're infected and the people in contact with are infected. those are highly sensitive and highly specific. they are more expensive, they take a little longer to get the results. you would like to get it in one to two days. many people unfortunately still have to wait multiple days to get it. even though we are doing much better now than months ago. the other one is an antigen test that is generally done for screening. it isn't as
that's why they made the safety clause in the eua. robert: can you walk through the accuracy of current tests? people are wondering this week what to do, which test to take. dr. fauci: there are a number of tests, three general types. tests for the virus itself, it is a pcr, a molecular test. tests for a component of the virus, which is an antigen test. and tests for the antibody to see if you have been infected and exposed. if you want to find out if a person absolutely is infected or not, for...
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Nov 13, 2020
11/20
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BBCNEWS
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as soon as the fda applies the eua.commercial industry and existing vaccine delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated pro rata by population so that we ensure fairand rata by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. 0k, so that is just about coming to the end of this conference. that is a general speaking about the distribution channels for a potential vaccine and therapeutics involved in operation warp speed. this is the programme that's been developed to increase and enable the developing of therapeutics and vaccines. lebo diseko has been listening in. what did you make of that? what will instruct me from what president trump said was, at that point when he started talking on lockdowns and the fact that he would not be locking down the country at all, he says, whatever happens in the future, who knows? that is the first time i've really heard any kind of even a nod to the possibili
as soon as the fda applies the eua.commercial industry and existing vaccine delivery capabilities and infrastructure. our nation deserves this. vaccines will be allocated pro rata by population so that we ensure fairand rata by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. 0k, so that is just about coming to the end of this conference. that is a general speaking about the distribution channels for a potential...
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Nov 29, 2020
11/20
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KTVU
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eye 142
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december 18th is when moderna is scheduled to submit its eua.hat's the plan from moderna and 28-48 hours after submitting we from a federal perspective have promised to set everything up so that we can quickly review those eua for a lesson hopefully sending out vaccines within 24 to 48 hours. our plan is to start by protecting the vulnerable. older people, particularly in long-term care facilities. we want to immunize for impact with the recognition that we will have 40 million doses of the vaccine by the end of this year and that won't be enough for the whole country. if you're part of the public, i want you to understand it will probably be end of first quarter, beginning of second quarter next year before you can get a vaccine, but you can go to coronavirus prevention network.org, sign up for a study and you could be -- you could get a vaccine in just a few days to weeks if you sign up for a study and understand that our strategy we are telling governors and states is to think about the vulnerable. if we protect them, then we can slow the spr
december 18th is when moderna is scheduled to submit its eua.hat's the plan from moderna and 28-48 hours after submitting we from a federal perspective have promised to set everything up so that we can quickly review those eua for a lesson hopefully sending out vaccines within 24 to 48 hours. our plan is to start by protecting the vulnerable. older people, particularly in long-term care facilities. we want to immunize for impact with the recognition that we will have 40 million doses of the...
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Nov 30, 2020
11/20
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FOXNEWSW
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december 10th is when pfizer will be submitting its eua. that's the plan. december 18th is when moderna is expected to submit the eua. that's the plan for moderna. within 24 to 48 hours from submitting the eua we have prom promised and set everything up so we can hopefully send out vaccines within 24 to 48 hours. our plan is to start protecting the vulnerable. we want to immuneize with impact. it won't be enough for the whole country. if you're part of the public i want you to understand, it will probably be in the first quarter, beginning of second quarter next year before you can get a vaccine. but you can go to coronaviruspreventionnetwork.org , sign up for a study and you can be getting a vaccine in a few days to weeks if you sign up for a study. understand that, again, our strategy that we're telling governors in states is to think about the vulnerable. if we protect them, then we can slow the spread of the disease and lower loss of life until everyone can get a vaccine, again in the first quarter, into the second quarter next year. >> and if the fda m
december 10th is when pfizer will be submitting its eua. that's the plan. december 18th is when moderna is expected to submit the eua. that's the plan for moderna. within 24 to 48 hours from submitting the eua we have prom promised and set everything up so we can hopefully send out vaccines within 24 to 48 hours. our plan is to start protecting the vulnerable. we want to immuneize with impact. it won't be enough for the whole country. if you're part of the public i want you to understand, it...
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Nov 20, 2020
11/20
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KGO
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so for pfizer to file for their eua is remarkable.distribute safe and effective vaccine to the american people. >> and what do you have stockpiled right now? how quickly can it get out? >> so we have about 40 million doses of vaccine give or take exactly when the eua comes out and what we're going to do is we're going to execute fair and equitable distribution based on the population of the jurisdictions, jurisdictions identified as the 50 states, eight territories and six metropolitan cities. and so coupled working with the states and the cdc, we have developed a very extensive plan on how to distribute the vaccine. i will tell you, our success is going to be because of our whole of america approach. it's really been remarkable. whether it's the scientists and health and human services, the planners, contractors, the great professional logisticians at the cdc. i just can't understate how powerful commercial industry has been in this effort, right? all the way from pfizer and moderna through mckesson which is going to distribute it in
so for pfizer to file for their eua is remarkable.distribute safe and effective vaccine to the american people. >> and what do you have stockpiled right now? how quickly can it get out? >> so we have about 40 million doses of vaccine give or take exactly when the eua comes out and what we're going to do is we're going to execute fair and equitable distribution based on the population of the jurisdictions, jurisdictions identified as the 50 states, eight territories and six...
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Nov 30, 2020
11/20
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FBC
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one week after the pfizer eua on december 10th.he top scientist on "operation warp speed" laid out this potential runway going forward. >> there are two more vaccines in phase two trial and prepared to enter phase three in the next two weeks to come. the vaccine from novavax, the biotech company in the u.s. and sanofi-aventis glaxosmithkline combination. two more to be available late january, february and then the last two available probably somewhere in april, may. reporter: back to moderna though for a second. this was the initial reaction from president trump, taking to twitter, moderna applying for emergency vaccine approval. fda must act quickly. however, david, the fda has been pretty clear on this when it comes to the eu a process. when an eua is submitted to them it will be likely weeks to review. they want to look at all the data before them. they want this vetted, thorough and transparent. neil: david: deregulation one of the key components of blake, thank you very much. stocks not reacting like the last few mondays to th
one week after the pfizer eua on december 10th.he top scientist on "operation warp speed" laid out this potential runway going forward. >> there are two more vaccines in phase two trial and prepared to enter phase three in the next two weeks to come. the vaccine from novavax, the biotech company in the u.s. and sanofi-aventis glaxosmithkline combination. two more to be available late january, february and then the last two available probably somewhere in april, may. reporter:...
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225
Nov 19, 2020
11/20
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CSPAN3
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eye 225
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and, finally, a word about the eua process. when the fda scientists are left alone to examine the science and data, the process largely works. they understand the urgency of the moment and the need for faster improvements but authorizing therapy due to political pressure or little to no data does far more harm than good. as a physician, i've been troubled by the plitzation of hydroxycholoroquine. it's a potential therapy. we should study it. if it works, we should use it. if it doesn't, we shouldn't. but i have to be honest, give the dismal failure of hydroxycholoroquine to date, there is little scientific basis to think it will be effective for anybody. at this point in the pandemic, with so much suffering and death, we should focus our efforts on promising approaches to help americans get through the crisis. thank you very much. >> thank you, doctor. i said in the hoping statement, i kind of figured it was going to not necessarily as broad of a discussion based on other early treatments and we're going to get into dispute on
and, finally, a word about the eua process. when the fda scientists are left alone to examine the science and data, the process largely works. they understand the urgency of the moment and the need for faster improvements but authorizing therapy due to political pressure or little to no data does far more harm than good. as a physician, i've been troubled by the plitzation of hydroxycholoroquine. it's a potential therapy. we should study it. if it works, we should use it. if it doesn't, we...
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Nov 24, 2020
11/20
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CSPAN
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eye 46
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finally, a word about the eua process. when the fda scientists are left alone to examine the science and data, the process largely works. they understand the urgency of the moment and the need for faster approvals. but authorizing therapies due to political pressure or with little to no data does far more harm than good. as a physician i've been troubled by the politicization of hydroxychloroquine and it is a potential therapy. we should study it and if it works, we should use it and if it doesn't, we shouldn't. givenhave to be honest, the dismal failure of hydroxychloroquine, to date there is little scientific basis that it will be effective for anybody and at this point in the pandemic with so much suffering and death, we should focus our efforts on promising approaches to help americans get through the crisis. >> thank you, dr.. as i said in my opening statement i figured this would not necessarily be as broad a discussion based on other early treatments. dispute oninto the hydroxychloroquine. we have a disconnect betwe
finally, a word about the eua process. when the fda scientists are left alone to examine the science and data, the process largely works. they understand the urgency of the moment and the need for faster approvals. but authorizing therapies due to political pressure or with little to no data does far more harm than good. as a physician i've been troubled by the politicization of hydroxychloroquine and it is a potential therapy. we should study it and if it works, we should use it and if it...
360
360
Nov 28, 2020
11/20
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CNNW
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eye 360
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the fda will not approve a vaccine, even under eua, until it's safe. there are a lot of eyes looking at this. we'll see the data. no vaccine will be released unless it's safe. everyone should get the vaccine as soon as they can. >> we appreciate you sharing that message. dr. jonathan ryeiner, thank you so much. >>> the peach state has become the center of the political universe as president trump plans a trip to georgia to campaign for two republican senators in a runoff election. how is he going to impact the race and the balance of power in washington? we're all putting things off, especially in these times. but some things are too serious to be ignored. if you still have symptoms of crohn's disease or ulcerative colitis even after trying other medications, it may be a sign of damaging inflammation, which left untreated, could get much worse. please make an appointment to see your gastroenterologist right away. or connect with them online. once you do, seeing the doctor is one less thing to worry about. need help finding a doctor? head to crohnsandco
the fda will not approve a vaccine, even under eua, until it's safe. there are a lot of eyes looking at this. we'll see the data. no vaccine will be released unless it's safe. everyone should get the vaccine as soon as they can. >> we appreciate you sharing that message. dr. jonathan ryeiner, thank you so much. >>> the peach state has become the center of the political universe as president trump plans a trip to georgia to campaign for two republican senators in a runoff...
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Nov 20, 2020
11/20
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CSPAN2
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eye 55
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the basis for the hydroxychloroquine eua was from laboratory studies and really ultimately one small non- randomized, non- blinded study of hospitalized patients in france findings that were later discredited and the scientist was now facing disciplinary actions. since then dozens of studies have examined the efficacy of hydroxychloroquine and here is the bottom line. every single high-quality study has failed to find any benefit of hydroxychloroquine for covid-19. i have to say i'm disappointed and hydroxychloroquine is a cheap and widely available edison and had a fun and affected it would've made an enormous difference in this pandemic but unfortunately it isn't effective and it is not. there is no clear consensus in the medical and scientific committee based on overwhelming evidence that hydroxychloroquine provides no benefit in treating covid-19. this includes in the outpatient so let's talk evidence. a large randomized controlled trial published in the new england journal of medicine found no benefit of hydroxychloroquine given to outpatient with exposing to the sars covid two
the basis for the hydroxychloroquine eua was from laboratory studies and really ultimately one small non- randomized, non- blinded study of hospitalized patients in france findings that were later discredited and the scientist was now facing disciplinary actions. since then dozens of studies have examined the efficacy of hydroxychloroquine and here is the bottom line. every single high-quality study has failed to find any benefit of hydroxychloroquine for covid-19. i have to say i'm...
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Nov 30, 2020
11/20
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BLOOMBERG
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eye 105
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review those eua's and hopefully start sending out vaccines within 24 to 48 hours.n: that was the u.s. surgeon general speaking to fox news sunday before we got the news from moderna they are planning to request clearance for the coronavirus vaccine in the u.s. and europe as soon as today. alongside lisa abramowicz, i'm jonathan ferro. bad ofn "the open,"'s socgen -- subadra rajappa of socgen. the focus on what is not happened in this market in november. lisa: the question on whether this is policy or abet on fundamentals not being as strong as people are pressing into the equity market. you cannot miss that. we will be watching. a look at thee vaccine distribution. the moderna news accelerating the timeline. operation warp speed taking more shape. , yaleward foreman joining university. i want to start with operation warp speed and where we are based on the application from moderna, based on what the fda has signaled. when you think we will get a trickle turn into a flood where we get a critical mass of people in united states being inoculated? dr. foreman: i am one
review those eua's and hopefully start sending out vaccines within 24 to 48 hours.n: that was the u.s. surgeon general speaking to fox news sunday before we got the news from moderna they are planning to request clearance for the coronavirus vaccine in the u.s. and europe as soon as today. alongside lisa abramowicz, i'm jonathan ferro. bad ofn "the open,"'s socgen -- subadra rajappa of socgen. the focus on what is not happened in this market in november. lisa: the question on whether...
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Nov 21, 2020
11/20
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MSNBCW
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eye 147
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. >>> for pfizer to be filing for their eua is just remarkable. we have about 40 million doses of vaccine give or take exactly when the eua comes out. and what we're going to do is we're going to execute fair and equitable distribution. >> he's the logistics guy. army general gus perna heads up the military effort to ship and inoculate millions of americans that vaccine. an fda vaccine advisory committee begins reviewing pfizer's emergency use authorization request december 10th. but members of an independent vaccine working group including our next guest, professor arthur kaplan, have concerns. they write, quote, an emergency use authorization would potentially open the flood gates to deploy an unapproved and unlicensed vaccine to millions or tens of millions of individuals before gathering the proof of safety and efficacy that licensing a new vaccine typically demands. for more we are so pleased to welcome to the broadcast the aforementioned arthur kaplan. he's a professor of bioethics. authored and edited dozens of books including a recent one
. >>> for pfizer to be filing for their eua is just remarkable. we have about 40 million doses of vaccine give or take exactly when the eua comes out. and what we're going to do is we're going to execute fair and equitable distribution. >> he's the logistics guy. army general gus perna heads up the military effort to ship and inoculate millions of americans that vaccine. an fda vaccine advisory committee begins reviewing pfizer's emergency use authorization request december 10th....
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Nov 30, 2020
11/20
by
FBC
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is safe, part of the reason why they are applying as well for the emergency use authorization, the eua, to the fda. but also, here's what the company was highlighting today as well. they say in their phase 3 clinical trial study, there were 30 severe cases. all 30 were those for people who were given the placebo, not the vaccine. listen here to that company's ceo from earlier this morning. watch. >> and what is even most exciting, i was pleased yesterday when i learned about the data, there were 30 severe cases in the study. all 30 were on placebo. there were zero cases of people with the vaccine. if you think about the impact of severe cases driving hospitalization, driving people in icu and death, that is a game changer. reporter: we know as it relates to pfizer, the fda will be taking up the eua for that vaccine candidate on december 10th. moderna said today, at least he suggested the fda could potentially take that up for moderna on december 17th, one week later. the fda, we should say, has not yet at least publicly acknowledged that possibility. by the way, as it relates to distri
is safe, part of the reason why they are applying as well for the emergency use authorization, the eua, to the fda. but also, here's what the company was highlighting today as well. they say in their phase 3 clinical trial study, there were 30 severe cases. all 30 were those for people who were given the placebo, not the vaccine. listen here to that company's ceo from earlier this morning. watch. >> and what is even most exciting, i was pleased yesterday when i learned about the data,...
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Nov 18, 2020
11/20
by
FBC
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eye 60
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reporter: even if pfizer ends up applying for this eua, connell, within the next couple days or so itill likely take several weeks before it would potentially get out to the marketplace because the fda has said their review process for the eua very well could take weeks. they want it to be thorough, transparent and want it to be very tedious, connell? >> still great news from pfizer. even with the market selling off doesn't take away from that. we'll talk about other things going on at the moment around the country n addition to pfizer we heard from johnson & johnson, its ceo today? reporter: we did. the alex gorski, the ceo did a virtual event with david rubenstein from the washington economic club. he sounded hopeful as it relates to the one-shot dose his company is working on. >> we use i had it in both formats, one and two shots and we're going to have to find more information. the early data that we were able to generate both pre-clinically as well as in the clinic our phase one trial suggested that we do have a robust response and that is again how the body responds in producing
reporter: even if pfizer ends up applying for this eua, connell, within the next couple days or so itill likely take several weeks before it would potentially get out to the marketplace because the fda has said their review process for the eua very well could take weeks. they want it to be thorough, transparent and want it to be very tedious, connell? >> still great news from pfizer. even with the market selling off doesn't take away from that. we'll talk about other things going on at...
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136
Nov 30, 2020
11/20
by
FOXNEWSW
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eye 136
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it is part of the reason why they're now applying to the fda for their eua that is the emergency usezation. here's the potential schedule going forward the fda set to take up firestone's candidate on december 10th. and suggested moderna could be one week after that. >> the fda has indicated to us that likely the advisory committee should happen on december 17 and hopefully everything goes well in the next couple weeks, you could expect between i would say a day or two meaning we are able to ship the product. >> now, when the fda eventually approves a vaccine whatever it might be pfizer, mow concernna, something else down the line, operation warp speed the secretary over at health and human services alex azar says distribution will then begin immediately. >> well, as you said it will ship within 24 hours after fda approval and up to nursing homes, hospitals and pharmacies to get that dispensed it. really could be within days of fda approval we will start seeing vaccines in people's arms incredible 10 months into this pandemic hitting our shores thanks to what president trump has done
it is part of the reason why they're now applying to the fda for their eua that is the emergency usezation. here's the potential schedule going forward the fda set to take up firestone's candidate on december 10th. and suggested moderna could be one week after that. >> the fda has indicated to us that likely the advisory committee should happen on december 17 and hopefully everything goes well in the next couple weeks, you could expect between i would say a day or two meaning we are able...
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202
Nov 10, 2020
11/20
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MSNBCW
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eye 202
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that study that triggered the eua, the emergency use authorization, were predominantly in outpatients, individuals to prevent them from going to the hospital. as you know, i've discussed with you on your show, andrea, some time ago, that we have quite good things now, interventions for people who have advanced disease, who are in the hospital, who are intubated, who are on ventilators, who require oxygen. that's good, we need more of those. but we have some of them that are working well which likely is contributing to a decrease in the deaths that we see when people do go into the hospital. what we need more of is what the question you just asked me, we need more of those interventions that prevent people from going in the hospital. the monoclonal antibody from lily that was just given an eua is one of a group of these types of interventions early on. there are monoclonal antibodies from companies like regeneral other on, there are direct antivirus that we're working on. we just had a workshop yesterday or the day before in which we're trying to galvanize activity to do the kind of dr
that study that triggered the eua, the emergency use authorization, were predominantly in outpatients, individuals to prevent them from going to the hospital. as you know, i've discussed with you on your show, andrea, some time ago, that we have quite good things now, interventions for people who have advanced disease, who are in the hospital, who are intubated, who are on ventilators, who require oxygen. that's good, we need more of those. but we have some of them that are working well which...
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Nov 10, 2020
11/20
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MSNBCW
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eye 131
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it's not in approval or in eua yet. we don't think they'll ask for another eua until they hit a safety milestone. let's talk about what it does do and what we know and don't know. we know it's 90% effective at presenting severe illness. this was a group of 94 cases, nine of which happened in the vaccine group, the remainder in the placebo group. does it prevent severe disease? is it durable? how long will this immunogenicity last? is it effective in pregnant women? is it effective in children? does it prevent severe disease? these are all unknowns, craig. we haven't really seen the full data yet. we're certainly looking forward to seeing that. not to diminish the announcement. this exceeded expectations. craig, we talk about the flu shot every year, 40% to 60% effective. this wildly super seeds that which is very, very, very exciting. but remember, we talk about this a lot. it's not going to be immediately available to everybody. that doesn't mean you throw away your mask. you still have to do all these mitigation behav
it's not in approval or in eua yet. we don't think they'll ask for another eua until they hit a safety milestone. let's talk about what it does do and what we know and don't know. we know it's 90% effective at presenting severe illness. this was a group of 94 cases, nine of which happened in the vaccine group, the remainder in the placebo group. does it prevent severe disease? is it durable? how long will this immunogenicity last? is it effective in pregnant women? is it effective in children?...
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Nov 21, 2020
11/20
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MSNBCW
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eye 157
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this eua for this product is encredibly exciting but not available until the spring, however.need a doctor's prescription and it costs $50. that's limiting's we need more of these tests to get into the market driving down the cost. basically you want a test that's as easy to do as a pregnancy test to get accurate results very, very quickly. >> yeah. very good points you make, as always, dr. natalie azar, thank you. >>> one of the most critical decisions the incoming biden administration has to make with global implications and a race against the clock for a president biden. what happens if the clock runs out? ahhhahh! i'm saved! water tastes like, water. so we fixed it. mio. i guess i look pretty... ridiculous. [ chuckles ] no one looks ridiculous, bob. progressive is always here for you with round-the-clock service. just so you know, next time, you can submit a claim with our mobile app. good. thanks again for -- for rushing over. are you kidding? this is what 24/7 protection looks like. okay. -you smell like fish. -sorry. i was talking to jamie. the coronavirus isn't waiting
this eua for this product is encredibly exciting but not available until the spring, however.need a doctor's prescription and it costs $50. that's limiting's we need more of these tests to get into the market driving down the cost. basically you want a test that's as easy to do as a pregnancy test to get accurate results very, very quickly. >> yeah. very good points you make, as always, dr. natalie azar, thank you. >>> one of the most critical decisions the incoming biden...
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Nov 25, 2020
11/20
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FOXNEWSW
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we have two successful vaccine candidates, likely an eua by the end of 2020, secretary alex azar has a likely 20 million americansy will be vaccinated by the end of 2020. we have no anticipation this was going to happen. this was absolutely incredible, and we should be celebrating this moment right now, and not to mention, regeneron's -- the antibody treatment has just gotten its eua approval, and it has been shipped 35,000 doses were justt shipped today under operation warp speed. this is one of the treatments that has proven to keep people out of the hospital and lessen the severity of the illness. rather than people, you know, up in arms right now about other things, we should be celebrating true scientific discovery. >> jason: yeah, if donald trump had not put this in motion back in january, can only imagine where we would be at as we turn the corner into december. but pete, what has so. many people off and just outraged is the blatant hypocrisy. we could go for hours on this show talking about the hypocrisy, but from your perspective, what do you see? >> it is hypocrisy come of
we have two successful vaccine candidates, likely an eua by the end of 2020, secretary alex azar has a likely 20 million americansy will be vaccinated by the end of 2020. we have no anticipation this was going to happen. this was absolutely incredible, and we should be celebrating this moment right now, and not to mention, regeneron's -- the antibody treatment has just gotten its eua approval, and it has been shipped 35,000 doses were justt shipped today under operation warp speed. this is one...
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Nov 13, 2020
11/20
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FOXNEWSW
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we will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and the existing vaccine capabilities and infrastructure. our nation deserves this. vaccines will be allocated by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely, along with the cdc, the 64 jurisdictions and states to assure the vaccine can quickly and safely get to those who need it first. and then we have plans to ensure that it spreads exponentially across our country and that no places left without a vaccine. at the end of the day, our success is going to be judged by the availability of the vaccine as shots go and arms. it is the partnerships we have formed with the pharmaceutical companies like pfizer in madura. distribution companies like fedex and ups, and pharmacies like cvs and walgreens that have agreed to do things differently, to think how can we get this to the american people in the most rapid and expeditious way? we
we will do that within 24 hours of the eua. we are harnessing the strength of commercial industry and the existing vaccine capabilities and infrastructure. our nation deserves this. vaccines will be allocated by population so that we ensure fair and equitable across. we need the states who are part of the planning to accept the vaccine. we are working closely, along with the cdc, the 64 jurisdictions and states to assure the vaccine can quickly and safely get to those who need it first. and...
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Nov 25, 2020
11/20
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KGO
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through their process, and hopefully they'll determine it's safe and effective and they'll award an euagency use authorization. >> reporter: he says pending fda authorization, the vaccine could be available as soon as mid-december. >> me personally, i have to visualize things. >> reporter: he tracks everything from his office in washington, d.c. on a white board, mapping out the strategy and timing for vaccine delivery. he even has a nickname for the day vaccines are cleared to be distributed. d-day. >> so let's just say d-day is the 15th. right? 24 hours later, vaccines are on the street, right? >> 24 hours, all it's going to take? >> right. >> it's just a phone call about execution? >> pfizer's first, i'll call pfizer, they'll begin distributing vaccines. it will go to 64 jurisdictions simultaneously. 50 states, 8 territories, 6 metropolitan cities. >> reporter: part of being prepared for distribution, making sure that states have the equipment necessary for the vaccines to be administered. >> these are called ancillary kits. these come with the vaccine. it's a lot of syringes, a lot
through their process, and hopefully they'll determine it's safe and effective and they'll award an euagency use authorization. >> reporter: he says pending fda authorization, the vaccine could be available as soon as mid-december. >> me personally, i have to visualize things. >> reporter: he tracks everything from his office in washington, d.c. on a white board, mapping out the strategy and timing for vaccine delivery. he even has a nickname for the day vaccines are cleared...
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Nov 18, 2020
11/20
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FOXNEWSW
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you will hear a lot about eua.t will be possible to start immunizing the highest risk people possible in december. how many doses? well, because warp speed has been funding the manufacturing of these vaccine doses. even before we knew they were going to work. because you didn't want to have to have a loption wait there, there will be about 40 million doses available in december. but, before you say 40 million people, keep in mind these vaccines require two dozens so that's really 20 million people and there will have to be a very careful plan made and it's in the works right now about how to offer those to the people at highest risk. >> martha: it's incredible testament to the private sector and the public sector and the government which don't always work together so seamlessly and we are all -- we hope that this goes very well with the fda. and i hope you will come back because i have a lot more questions for you, dr. collins and we are all going to be looking at this very closely. thank you very much, sir. >> i w
you will hear a lot about eua.t will be possible to start immunizing the highest risk people possible in december. how many doses? well, because warp speed has been funding the manufacturing of these vaccine doses. even before we knew they were going to work. because you didn't want to have to have a loption wait there, there will be about 40 million doses available in december. but, before you say 40 million people, keep in mind these vaccines require two dozens so that's really 20 million...
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Nov 13, 2020
11/20
by
FBC
tv
eye 79
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we will do that within 24 hours of the eua, we are harnessing the strength of commercial industry and the existing vaccine delivery capabilities and infrastructure, our nation deserves this. vaccines will be allocated by population which we ensure a fair and equitable across we need the states who are part of the planning to accept the vaccine, we are working closely along with the cdc, the 64 jurisdictions and states to ensure vaccine can safely and quickly get to those who need it first and then we have plans to ensure that it spreads exponentially across the country and that no place is left without a vaccine. at the end of the day our success will be judged by the availability of the vaccine as the shots go into arms. it is the partnerships we have formed with the pharmaceutical companies like pfizer and moderna like distribution like mckesson, fedex and ups and pharmacies like cbs and walgreens that have agreed to do things differently, to think how can we get this to the american people and the most rapid way. we will be successful because all america approach, the collaboration
we will do that within 24 hours of the eua, we are harnessing the strength of commercial industry and the existing vaccine delivery capabilities and infrastructure, our nation deserves this. vaccines will be allocated by population which we ensure a fair and equitable across we need the states who are part of the planning to accept the vaccine, we are working closely along with the cdc, the 64 jurisdictions and states to ensure vaccine can safely and quickly get to those who need it first and...
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Nov 16, 2020
11/20
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KGO
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be deliberated by a group of scientists and other regulators and the emergency use authorization or euas what we would expect sometimes after thanksgiving, hopefully, and ready for rollout. pfizer saided that they'll have as much as 50 million doses by the end of 2020. moderna said 20 million doses. >> ok. let me just ask you. the administration on the federal government level, they've put a lot of resources into developing the vaccine, but what about the distribution? that is, are the states and counties kind of ready to roll? are those plans all set once the vaccine is produced? >> the devil is in the details, and those details are very opaque right now. part of it politically is for the current administration to give the blueprints to president biden, but there is no movement towards giving them that blueprint yet. we know the military will be involved. there have been some test states, california is one of them, that have be instructed to design the system. the exact components of the system, we don't really know yet. >> all right. well, president-elect biden said today more people
be deliberated by a group of scientists and other regulators and the emergency use authorization or euas what we would expect sometimes after thanksgiving, hopefully, and ready for rollout. pfizer saided that they'll have as much as 50 million doses by the end of 2020. moderna said 20 million doses. >> ok. let me just ask you. the administration on the federal government level, they've put a lot of resources into developing the vaccine, but what about the distribution? that is, are the...
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Nov 20, 2020
11/20
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KGO
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. >> i can look you in the face and say to you, eua comes, 24 hours later, vaccines will be distributed out to the american people and be ready for administration. >> reporter: hospitalizations are now climbing in all 50 states. nearly 80,000 patients, a new record. icus hit hard in south dakota, where new cases have surged by 400% in the last two months. still no statewide mask mandate. >> a lot of us are tired of seeing the negative comments from the community, the lack of understanding of how serious this illness is. >> reporter: tonight, about 100 of the country's biggest hospital groups out with a new ad begging the public to do their part and wear a mask. healthcare workers grinding through exhaustion, eight months into the pandemic. >> every day we come into work it's going to be one of the worst day we've had. >> reporter: ohio reaching critical hospitalization levels and california ordering a curfew in hard-hit counties between 10:00 p.m. and 5:00 a.m. outside oklahoma city 13-year-old devon embry went from the football field to the icu. now, fighting for his life on oxygen. >>
. >> i can look you in the face and say to you, eua comes, 24 hours later, vaccines will be distributed out to the american people and be ready for administration. >> reporter: hospitalizations are now climbing in all 50 states. nearly 80,000 patients, a new record. icus hit hard in south dakota, where new cases have surged by 400% in the last two months. still no statewide mask mandate. >> a lot of us are tired of seeing the negative comments from the community, the lack of...
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Nov 20, 2020
11/20
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CSPAN2
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eua says when the preponderance of evidence shows the drug works and has safety we ought to go. my view is we need to go with this and everybody high-risk in america. >> doctor risch, when you listen to doctor ashish jha it sounds authoritarian so do you have a response connect. >> yes, thank you. ank you. i think that what i said early on about the conation of hospital with outpatient studies is apparent that there has been also studi and there is no doubt that there are plenty of hospital studies and some of those hospital studies in deed showed no benefit and it is not harmed there are reasons for that and i don't want to get into the technical sues of the studies but just to say it's irrelevant. study of hospital patients are irrelevant we are considering outpatient disease and outpatient treatment and treatment that starts in the first five days. there are only seven studies and doctor ashish j says they are t high-quality studies but in fact, they are high-quality studies and controlled studies and were passed out two randomized except that the patits chose whether to take
eua says when the preponderance of evidence shows the drug works and has safety we ought to go. my view is we need to go with this and everybody high-risk in america. >> doctor risch, when you listen to doctor ashish jha it sounds authoritarian so do you have a response connect. >> yes, thank you. ank you. i think that what i said early on about the conation of hospital with outpatient studies is apparent that there has been also studi and there is no doubt that there are plenty of...
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Nov 20, 2020
11/20
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KPIX
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distribution could start within weeks. >> eua comes, 24 hours later, vaccines will be distributed. >reporter: dr. anthony fauci called the results of coronavirus vaccine trials extraordinary and he urged all americans to get vaccinated as soon as possible. >> the process of the speed did not compromise at all safety, nor did it compromise scientific integrity. >> reporter: dr. fauci also said right now more than ever before, americans should double down on hand washing, mask wearing and social distancing. >> if you are fighting a battle and the cavalry is on the way, you don't stop shooting. >> reporter: meanwhile, the fight continues in icus across america where nurses are battling not just the virus but denial. registered nurse ashley bartholemew was shocked when one of her covid patients in an el paso hospital told her this. >> just kind of gestured towards the tv like, well, fake news. it doesn't really seem like it's more than a flu. i said to him, i have never seen so much death and so much sickness in the past two weeks than i have in my entire ten years in health care combine
distribution could start within weeks. >> eua comes, 24 hours later, vaccines will be distributed. >reporter: dr. anthony fauci called the results of coronavirus vaccine trials extraordinary and he urged all americans to get vaccinated as soon as possible. >> the process of the speed did not compromise at all safety, nor did it compromise scientific integrity. >> reporter: dr. fauci also said right now more than ever before, americans should double down on hand washing,...
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Nov 11, 2020
11/20
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CNNW
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once that decision is made whether or not to issue an eua, then the next process needs to occur, whiche logistics. we know that vaccines don't save lives, it's vaccination which saves lives. we have to get the vaccine doses to the locations where people can access them and be vaccinated. we know that there are not going to be enough doses of vaccine to vaccinate of entire country immediately. so there's going to be a staggered roll-out of vaccines to certain groups and higher prior groups. so, for example, healthcare professionally or first responders or people in the highest risk groups for covid. so my expectation is assuming that the process continues to proceed as it has, there will probably not be a substantial roll-out of vaccine until the first or second quarter of calendar year '21. >> based on all those other factors you mentioned. i wonder what you think about when life is going to start to return to normal in the u.s. do you have any idea? >> i wish i did have an idea. i have a feeling that normal life will not be 2019 normal or 2019 normal. i think this pandemic has certain
once that decision is made whether or not to issue an eua, then the next process needs to occur, whiche logistics. we know that vaccines don't save lives, it's vaccination which saves lives. we have to get the vaccine doses to the locations where people can access them and be vaccinated. we know that there are not going to be enough doses of vaccine to vaccinate of entire country immediately. so there's going to be a staggered roll-out of vaccines to certain groups and higher prior groups. so,...
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Nov 20, 2020
11/20
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CNBC
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and as soon as the eua is approved within 24 hours the vaccines will be in the immunization sites and people will be immunized. the difference is we don't have 300 million doses. we will have as the month goes by within the month of december, up to 35 to 40 million doses enough to immunize more or less 20 million high risk individuals. and then -- >> i appreciate everything you're saying, but -- >> we can immunize on the monthly baseis >> let me give you my forecast, chaos. i deal with the corporations involved in this chain of command, no one knows what is going to happen. you think cvs knows what is going to happen. you go to cvs in two weeks and they say, listen, when we get the plan, we're ready to roll. i've done the homework on this, sir, you are not ready and it is not just you don't have enough vaccines, it is just because no one has a plan down there. >> i like to disagree with you i think i have attended many rehearsal and review meetings, and i think it is actually ready to the minute, and i guess exactly like people were saying six months ago, this will never happen, we wi
and as soon as the eua is approved within 24 hours the vaccines will be in the immunization sites and people will be immunized. the difference is we don't have 300 million doses. we will have as the month goes by within the month of december, up to 35 to 40 million doses enough to immunize more or less 20 million high risk individuals. and then -- >> i appreciate everything you're saying, but -- >> we can immunize on the monthly baseis >> let me give you my forecast, chaos. i...
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Nov 24, 2020
11/20
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FBC
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eye 197
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yeah, the pfizer vaccine if you recall, the eua was submitted last week. december 10th. there's a lot of data to be collected and pfizer has to put together safety data to ensure that not only was the vaccine safe in the people they gave it to but they'll be able to safely mass manufacture it. it's a lot of collecting paperwork, a lot of that red tape and moderna is also expected to submit for their eua very soon with their data review ten activity scheduled for -- ten tiltentatively scheduled for december 18th. within 24 hours of approval they're ready to ship out tens of millions of doses because they've been manufactured and they're ready to be distributed right away with tens, possibly 2 20 million americans being vaccinated by the end of 2020. dagen: with the astrazeneca vaccine, what's the timeline on that. we talked to somebody yesterday from astrazeneca. the phase three trial is ongoing in the united states, the data they were referencing was collected in studies that were done overseas and so it looks like that it's not -- they're not quite on the
yeah, the pfizer vaccine if you recall, the eua was submitted last week. december 10th. there's a lot of data to be collected and pfizer has to put together safety data to ensure that not only was the vaccine safe in the people they gave it to but they'll be able to safely mass manufacture it. it's a lot of collecting paperwork, a lot of that red tape and moderna is also expected to submit for their eua very soon with their data review ten activity scheduled for -- ten tiltentatively scheduled...
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Nov 16, 2020
11/20
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BLOOMBERG
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eye 51
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we are in daily discussions with them, what we will do, as soon as we get approval or eua by the u.s.then we will ship the product. we are very active in the seasonal flu process as well. we will get the vaccines out to hospitals and pharmacies. , cvs,ure you read walgreens, all of the big pharmacy chains have signed up to get a vaccine, to provide administration in the pharmacies. ceoie: that was the moderna earlier. for more, we are joined by the professors of international health and director of vaccine safety at the johns hopkins school of public health. changer? game did you wake up this morning delighted by the news? from is a good indication two companies that they appear to have effective vaccines. but they are press releases. no one has seen the data, i have not seen the data as shared publicly. it is a good indication that there are still a lot of details to follow. on that front, there are many details before this is even a consideration, but we know emergency use will be requested from regulators. what is your sense of how quickly that will translate into action, in other
we are in daily discussions with them, what we will do, as soon as we get approval or eua by the u.s.then we will ship the product. we are very active in the seasonal flu process as well. we will get the vaccines out to hospitals and pharmacies. , cvs,ure you read walgreens, all of the big pharmacy chains have signed up to get a vaccine, to provide administration in the pharmacies. ceoie: that was the moderna earlier. for more, we are joined by the professors of international health and...
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Nov 10, 2020
11/20
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CNNW
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eye 304
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people were getting it through the trials already, but the eua does potentially make it easier.his is the way to think about it, when you get a vaccine you're teaching your body to make antibodies, these proteins that could help fight the infection. you could just give those antibodies which is essentially what this product is, we can show how it works. it's typically given for mild to moderate illness. you want to give it early is the real point. if you do that, you reduce the likelihood that someone needs to be hospitalized, they need to visit an emergency room. it's one infusion and seems to last up to a couple months, one month at least. it's like a bridge to the vaccine. ultimately the vaccine is going to be the thing that everybody really wants. but in the interim, this bridge to the vaccine, the antibodies could provide benefit. as you mentioned, president trump received an antibody therapy. it was not this particular one. but that may have helped him. we're still collecting data on it but there's good evidence that it could help people who are in vulnerable position beca
people were getting it through the trials already, but the eua does potentially make it easier.his is the way to think about it, when you get a vaccine you're teaching your body to make antibodies, these proteins that could help fight the infection. you could just give those antibodies which is essentially what this product is, we can show how it works. it's typically given for mild to moderate illness. you want to give it early is the real point. if you do that, you reduce the likelihood that...