75
75
Sep 2, 2020
09/20
by
MSNBCW
tv
eye 75
favorite 0
quote 0
and that is aligned in both the guidelines and the eua. so yesterday, there was a lot of commotion, i think, about there possibly being conflict between the nih guidelines and the eua. and in fact if you sit down and read them both carefully, there really isn't that conflict. >> the president was discussing vaccines on a fox interview on monday and he then said, once you get to a certain number, you know we use the word "herd," once you get to a certain number it goes away so you know it doesn't have to be. are they still, at the white house, i know that some of the advisers have said they're not doing this, but are they talking about herd immunity and the risks, though, that are associated with that kind of rhetoric about herd immunity somehow making us all safe, getting enough people sick? >> i think you have to explain to the viewers what herd immunity is. herd immunity is when you have enough people who have either been infected and/or vaccinated and protected, that there's enough protection in the community that the virus doesn't have
and that is aligned in both the guidelines and the eua. so yesterday, there was a lot of commotion, i think, about there possibly being conflict between the nih guidelines and the eua. and in fact if you sit down and read them both carefully, there really isn't that conflict. >> the president was discussing vaccines on a fox interview on monday and he then said, once you get to a certain number, you know we use the word "herd," once you get to a certain number it goes away so...
111
111
Sep 2, 2020
09/20
by
MSNBCW
tv
eye 111
favorite 0
quote 0
not a phase three approval, we're talking about eua.ing of this raise concerns that the administration is speeding up the vaccine. >>> russia has been trying to raise doubts about the presidential candidates' health. dhs officials didn't release a bulletin on that disinformation effort. that's coming up. that's coming up a lot goes through your mind. with fidelity wealth management, your dedicated adviser can give you straightforward advice and tailored recommendations. that's the clarity you get with fidelity wealth management. and tailored recommendations. look limu! someone out there needs help customizing their car insurance with liberty mutual, so they only pay for what they need. false alarm. only pay for what you need. ♪ liberty. liberty. liberty. liberty. ♪ now that the rent's due but they've cut your pay. now that the virus has cost lives but your healthcare costs too much. now that our president has had months but he still doesn't have a plan. what happens now? joe biden knows how to lead through a crisis because he's done it
not a phase three approval, we're talking about eua.ing of this raise concerns that the administration is speeding up the vaccine. >>> russia has been trying to raise doubts about the presidential candidates' health. dhs officials didn't release a bulletin on that disinformation effort. that's coming up. that's coming up a lot goes through your mind. with fidelity wealth management, your dedicated adviser can give you straightforward advice and tailored recommendations. that's the...
121
121
Sep 23, 2020
09/20
by
CNNW
tv
eye 121
favorite 0
quote 0
this is inherent in the emergency use authorization process otherwise known as eua and it is akin toht approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge. so in the interest of transparency, i'd like to use this opportunity today to lay out the process we will use to review vaccines for covid-19. when a vaccine sponsor reaches the conclusion that the data from its phase 3 clinical trials are adequate to submit to fda, they will decide whether to apply for approval or emergency use authorization. this will be based upon the trial meeting pre-specified success criteria that were established by that sponsor. this is really important. they should also be consistent with fda recommendations regarding those criteria. fda will receive that application or submission and our career scientists will review it, safety and efficacy data as well as manufacturing quality and consistency data. fda made clear recommendations in our june 30 guidance regarding the safety and effectiveness of vaccines so that we can see that prior to the approval proces
this is inherent in the emergency use authorization process otherwise known as eua and it is akin toht approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge. so in the interest of transparency, i'd like to use this opportunity today to lay out the process we will use to review vaccines for covid-19. when a vaccine sponsor reaches the conclusion that the data from its phase 3 clinical trials are adequate to submit to fda, they will decide whether...
107
107
Sep 23, 2020
09/20
by
MSNBCW
tv
eye 107
favorite 0
quote 0
before we're to issue an eua, if they were to happen, fda would have to determine among other thingsutory standard is met. we expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine's quality and consistency and data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner. let me emphasize that again. data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner. fda also expects an eua request would include a plan for active followup to monitor safety among individuals who receive the vaccine. in the end, fda will not authorize or approve a vaccine that we would not feel comfortable giving to our families. on behalf of the 17,000-plus employees of the fda, i want to make the following commitments today to the public and this committee. fda will not authorize or approve any covid-19 vaccine before it has met the agency's rigorous specifications for safety and effectiveness. decisions to appro
before we're to issue an eua, if they were to happen, fda would have to determine among other thingsutory standard is met. we expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine's quality and consistency and data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner. let me emphasize that again. data from at least one well-designed phase three clinical trial that...
81
81
Sep 4, 2020
09/20
by
CNNW
tv
eye 81
favorite 0
quote 0
we know an eua for a vaccine is on the table. maybe, potentially for frontline workers, elderly people, just on a limited basis. but the concern, of course, is if they go forward with that before there's a consensus that it's ready. people believe they've seen politics have its play in hand with these other euas. they fear it could be that way with a vaccine. though, we should note, commissioner hahn and other officials have said they are basing these decisions on data, not on politics. >> you just mentioned, kaitlan, concern in the scientific community about fda commissioner steven hahn and how he's handled things. but i understand in this new reporting, there's also concern, i guess of a different kind, within the administration about dr. hahn. can you tell us about that? >> yeah. and it depends who you are looking at. there are career scientists at the fda who have not been on board with everything dr. hahn has said, including what he said about convalescent plasma. but also, west wing officials that were not happy he apologiz
we know an eua for a vaccine is on the table. maybe, potentially for frontline workers, elderly people, just on a limited basis. but the concern, of course, is if they go forward with that before there's a consensus that it's ready. people believe they've seen politics have its play in hand with these other euas. they fear it could be that way with a vaccine. though, we should note, commissioner hahn and other officials have said they are basing these decisions on data, not on politics....
286
286
Sep 1, 2020
09/20
by
CNNW
tv
eye 286
favorite 0
quote 0
what they say is for the fda to issue an eua, which is an emergency use authorization, there must beo adequate approved and available alternative for diagnosing, preventing or treating the disease. john, the thing is here, everyone wants a vaccine. most people want a vaccine. what's worked around the world is these public health things we've been talking about, wearing masks, social distancing. if the idea is the vaccine is going to help us get back to noermal, sure, that's true. until we are confident it is safe that's why you test it in tens of thousands of people, and effective, which you test with the passage of time, the idea of approving this or even giving it authorization is not something i'm hearing any public health officials recommend. >> vaccines are given to millions and millions of healthy people, which is why there's a different bar there. the washington post reported today that dr. scott analyst is a proponent of sorts of herd immunity, which he denies, but there are others who say he does support parts of it, how dangerous, how flawed do you think that would be? >> h
what they say is for the fda to issue an eua, which is an emergency use authorization, there must beo adequate approved and available alternative for diagnosing, preventing or treating the disease. john, the thing is here, everyone wants a vaccine. most people want a vaccine. what's worked around the world is these public health things we've been talking about, wearing masks, social distancing. if the idea is the vaccine is going to help us get back to noermal, sure, that's true. until we are...
330
330
Sep 1, 2020
09/20
by
CNNW
tv
eye 330
favorite 0
quote 0
and then three days later, the eua was authorized. it happened.ou know, the president had tweeted out in between saying, you know, the fda better see the light or they're going to feel the heat, or something like that. so, there was concern that this was done because of pressure, obviously. as you correctly mentioned, some of the data around that was exaggerated. with we don't know. that's the issue the nih is making here. if you look at the study, it compared patient who is got a higher dose of the convalescent plasma, patient who is got a lower dose and compared those two. you did not have a group that received convalescent plasma at all, a placebo, so to speak. we don't have enough data to know is this working, is it something else to patients we're giving or even safety questions you're racing. >> yeah, data is important. what do you think dr. schaffner? are you concerned there was political influence with this? >> well, the political influence seems to have been widely reported, and it certainly looks that way. the food and drug administratio
and then three days later, the eua was authorized. it happened.ou know, the president had tweeted out in between saying, you know, the fda better see the light or they're going to feel the heat, or something like that. so, there was concern that this was done because of pressure, obviously. as you correctly mentioned, some of the data around that was exaggerated. with we don't know. that's the issue the nih is making here. if you look at the study, it compared patient who is got a higher dose...
31
31
Sep 23, 2020
09/20
by
CSPAN3
tv
eye 31
favorite 0
quote 0
if they give an eua, i am confident it will be a safe vaccine, and i'm ready to take it. >> dr. redfield, i have a question for you on state immunization information systems in light of the vaccine program interim playbook. just have one question before high time expires. how many jurisdictions' immunization information systems meet all of the standards set forth in the playbook today? >> i would have to get back to you to be able to answer that specifically. i will say we are building on, as i mentioned, the system we regularly use in these 64 jurisdictions to distribute 80 million vaccine doses a year. in addition, there will be additional information capacity that will be put into where there are new points of service where that technology currently doesn't exist. but i'll have my team put together a comprehensive answer for you. >> thank you, senator casey. senator burr. >> thank you very much. welcome to all of our witnesses and our thanks to your agency and the many workers who work on this, and let me say to senator casey, answering his question, the majority has been foc
if they give an eua, i am confident it will be a safe vaccine, and i'm ready to take it. >> dr. redfield, i have a question for you on state immunization information systems in light of the vaccine program interim playbook. just have one question before high time expires. how many jurisdictions' immunization information systems meet all of the standards set forth in the playbook today? >> i would have to get back to you to be able to answer that specifically. i will say we are...
220
220
Sep 8, 2020
09/20
by
MSNBCW
tv
eye 220
favorite 0
quote 0
ceos of nine companies signed the pledge saying we want to make sure we're not going to go for the euahorization, until we're sure that the safety data and the effectiveness data is actually there to the point where we feel like it is safe, it is effective, it can get an emergency use authorization. this falls in line with what people said until now. dr. hahn with the fda has been saying all along, he wants to make sure it is safe and effective. there is a lot of political pressure on the fda to go ahead and approve it at this point. the white house adviser for the vaccine task group they have going has actually said he'll resign if they go ahead and get an eua, the emergency use authorization if he doesn't think it is safe and effective. this is helping get some of that political pressure off of them, and helping them to the point where hopefully the public starts having a little more confidence, hopefully a lot more confidence in the vaccine once it comes out. knowing it is safe. however, one step they can go further, they can make that data much more available, much more transparent
ceos of nine companies signed the pledge saying we want to make sure we're not going to go for the euahorization, until we're sure that the safety data and the effectiveness data is actually there to the point where we feel like it is safe, it is effective, it can get an emergency use authorization. this falls in line with what people said until now. dr. hahn with the fda has been saying all along, he wants to make sure it is safe and effective. there is a lot of political pressure on the fda...
549
549
Sep 3, 2020
09/20
by
CNNW
tv
eye 549
favorite 0
quote 1
the data was exaggerated around that eua. so, what i would say is, we've got to be very vigilant about this -- this vaccine. the idea that places are getting prepared. i mean, that makes sense. i mean, you -- you do want to be prepared. some of these vaccines may need to be stored at certain temperatures. all of that. but that shouldn't be the signal that the vaccine is ready to go. and also, as we have talked about, john, a vaccine should have a different bar than -- than a therapeutic medicine for somebody who's, you know, sick in a hospital, versus a vaccine given to healthy people has to have a higher bar. and if you look at the language, carefully, around why a -- an authorization would occur, it's usually because there is no viable alternative. right? well, i hate to say it. i know people don't like to hear this. but the alternative to a vaccine could be that, you know, we wear masks and distance longer. give us enough time to actually make sure this thing's really nailed down. >> so, professor haseltine, your take. how
the data was exaggerated around that eua. so, what i would say is, we've got to be very vigilant about this -- this vaccine. the idea that places are getting prepared. i mean, that makes sense. i mean, you -- you do want to be prepared. some of these vaccines may need to be stored at certain temperatures. all of that. but that shouldn't be the signal that the vaccine is ready to go. and also, as we have talked about, john, a vaccine should have a different bar than -- than a therapeutic...
139
139
Sep 8, 2020
09/20
by
MSNBCW
tv
eye 139
favorite 0
quote 0
whether or not the vaccine itself will be in production or available to anybody to take in their arm. >> eua of course being the emergency use authorization. over the weekend, dr. kass, new york's governor andrew cuomo announcing that his state's infection rate has been below 1% for 30 straight days. how significant is that? what can other states learn from that? >> so i think it's a really big deal, remembering new york is doing between 60 and 100,000 tests per day to show an infection rate of less than 1% on average for the state. also we are having outbreaks, especially in our college towns. one county that has an infection rate of 5%. what it means is if you mask up and test and trace, you can get yourself out of this pandemic without a vaccine. it's very encouraging. as a parent of new york city school system children, i'm really encouraged to be able to send my children back to school. >> this holiday, we saw a lot of clouds on beaches and boardwalks across the country. how real is the worry that there's going to be a spike in cases from the holiday weekend that we're wrapping up? >> a
whether or not the vaccine itself will be in production or available to anybody to take in their arm. >> eua of course being the emergency use authorization. over the weekend, dr. kass, new york's governor andrew cuomo announcing that his state's infection rate has been below 1% for 30 straight days. how significant is that? what can other states learn from that? >> so i think it's a really big deal, remembering new york is doing between 60 and 100,000 tests per day to show an...
227
227
Sep 14, 2020
09/20
by
CNNW
tv
eye 227
favorite 0
quote 3
early on they pressured the fda to issue an eua for hydroxychloroquine despite there being absolutely no data. right? we saw recently this really stilted release of the eua for plasma and now we see the mmwr, the really voice of the cdc being pressured by political hacks to try and change the message. they're trying to craft the message from our scientific organizations. this is not about the message. this is about science. but yet, the white house again tries to gag or alter the speech of our scientists. >> hard to do when every american is living through this one way or another. doctors, gradefteful to both of you. >>> we'll continue the conversation. gone, the president to bob woodward saying that he acted early an enthat his coronavirus management should be viewed as a success because the stock market is booming. ed quickly, safely, and beautifully, with a lifetime warranty. go from old to new. from worn to wow. the beautiful bath you've always wanted, done right, installed by one expert technician, all in one day. we've been creating moments like these for 35 years, and we're her
early on they pressured the fda to issue an eua for hydroxychloroquine despite there being absolutely no data. right? we saw recently this really stilted release of the eua for plasma and now we see the mmwr, the really voice of the cdc being pressured by political hacks to try and change the message. they're trying to craft the message from our scientific organizations. this is not about the message. this is about science. but yet, the white house again tries to gag or alter the speech of our...
185
185
Sep 2, 2020
09/20
by
CNNW
tv
eye 185
favorite 0
quote 0
fauci this morning on the "today" show. >> i have been through a number of vaccine trials in which eua's have been done and they were done when there was enough data that you'd feel comfortable it was safe and effective for the american public. >> now, jim, you mentioned that dr. fauci has said to you and other people we could have a vaccine by the end of this year. i will note, that's not november 3rd. that's an almost two month difference between election day and the end of the calendar year that's a long time, actually. >> no question and again, it comes down to who's going to make that decision who's going make that judgment as well. other new information this morning, data showing a rise in cases among children. what do we attribute to this? is it going back to school? it is more testing as they go back to school? >> you know, it could be both of those things but i think it's the going back to school part that's really giving -- really the big driver here. no parent will be surprised when i say that when children go back to school they're put in one place, they share their germs and
fauci this morning on the "today" show. >> i have been through a number of vaccine trials in which eua's have been done and they were done when there was enough data that you'd feel comfortable it was safe and effective for the american public. >> now, jim, you mentioned that dr. fauci has said to you and other people we could have a vaccine by the end of this year. i will note, that's not november 3rd. that's an almost two month difference between election day and the end...
111
111
Sep 3, 2020
09/20
by
CNNW
tv
eye 111
favorite 0
quote 0
the fda commissioner who has said he may ignore the advice of his own advisory committee and issue an eua, emergency use authorization even without phase 3 trials being done, it does, i think, worry a lot of us that there is a rush here. >> another 1056 americans died of coronavirus yesterday. the u.s. is struggling to bring the death rate down. the worrying trend here is the rate of new cases had been falling but that curve has been distinctly flat for a week now. and these outbreaks in the midwest are a big part of the reason. the minnesota department of health announcing the first known death stemming from the sturgis motorcycle rally in early august. iowa still seeing dangerous spikes. the number of people hospitalized near levels last seen in the spring. >> with that in mind, iowa state will no longer allow 25,000 fans at the college home opener. meat processing workers in iowa are still at an elevated risk of exposure which could threaten the meat supply. the governor is still refusing to mandate masks. joni ernst was forced to backtrack. she said she was skeptical of the official c
the fda commissioner who has said he may ignore the advice of his own advisory committee and issue an eua, emergency use authorization even without phase 3 trials being done, it does, i think, worry a lot of us that there is a rush here. >> another 1056 americans died of coronavirus yesterday. the u.s. is struggling to bring the death rate down. the worrying trend here is the rate of new cases had been falling but that curve has been distinctly flat for a week now. and these outbreaks in...
316
316
Sep 2, 2020
09/20
by
CNNW
tv
eye 316
favorite 0
quote 0
keep in mind, wolf, the threshold for issuing an eua is pretty low. it's not as if you have approved this as something fda says is definitely safe and effective. it might be and, hence, they granted that. that is their responsibility. that's what they did. i completely support their ability to make their decisions. >> so you disagree correct me if i'm wrong with the president when he says this was a breakthrough >> i think there was a modest statement in advance of -- in terms of the way we're -- the things we're all waiting for desperately. it kind of breaks my heart that suddenly this divides us. here we are, you just reported 185,000 people have lost their lives to covid-19. we should be coming together and not trying to identify circumstances like this where we can try to identify that there is some controversy. there really shouldn't be. >> if you or someone you love were hospitalized with coronavirus, and sadly a lot of us know people hospitalized with coronavirus, would you want convelescent plasma based on what you know right now? >> i don't k
keep in mind, wolf, the threshold for issuing an eua is pretty low. it's not as if you have approved this as something fda says is definitely safe and effective. it might be and, hence, they granted that. that is their responsibility. that's what they did. i completely support their ability to make their decisions. >> so you disagree correct me if i'm wrong with the president when he says this was a breakthrough >> i think there was a modest statement in advance of -- in terms of...
94
94
Sep 23, 2020
09/20
by
FOXNEWSW
tv
eye 94
favorite 0
quote 0
this is inherent in the emergency use authorization process otherwise known as eua and akin to how aapproach a patient in an emergency situation. constantly updating a treatment plan as new data emerge. so in the interests of transparency i would like to take this opportunity to lay out the process we will use to review vaccines for covid-19. when a vaccine sponsor reaches the conclusion that the data from its phase 3 clinical trials are adequate to submit to fda, they will decide whether to apply for approval or emergency use authorization. this will be based upon the trial meeting pre-specified success criteria that were established by that sponsor. this is really important. they should also be consistent with fda recommendations regarding those criteria. fda will receive that application for submission and our career scientists will review all the data. fda made clear recommendations regarding the safety and effectiveness of vaccines so that we can see that prior to the approval process. we will also work to provide additional information so that it is clear what we expect to see
this is inherent in the emergency use authorization process otherwise known as eua and akin to how aapproach a patient in an emergency situation. constantly updating a treatment plan as new data emerge. so in the interests of transparency i would like to take this opportunity to lay out the process we will use to review vaccines for covid-19. when a vaccine sponsor reaches the conclusion that the data from its phase 3 clinical trials are adequate to submit to fda, they will decide whether to...
571
571
Sep 3, 2020
09/20
by
CNNW
tv
eye 571
favorite 0
quote 0
approval of eua of hydroxychloroquine in march with zero data. if these agencies are left to do their work, i am confident the american people will get a safe and effective vaccine. we have a saying in the procedure world here in the hospital that in an emergency, we move quickly but we don't rush. and that's what i want to see from the fda. and that's what tony fauci is talking about, moving quickly but not rushing. do all the due diligence. i think if left to their own natural instincts, that's what the fda will do. >> sanjay, i was fascinated to see, too, as we're learning more about the recommendations that have come out from the white house task force to specific states, these six states who were urged to put mask mandates in place as cases were beginning to surge, including your home state of georgia, where you are now, it's fascinating that we're seeing the science and the officials -- we're what, seven months into this, the fact that some of that science is still being ignored. you talked to officials and scientists and experts every day,
approval of eua of hydroxychloroquine in march with zero data. if these agencies are left to do their work, i am confident the american people will get a safe and effective vaccine. we have a saying in the procedure world here in the hospital that in an emergency, we move quickly but we don't rush. and that's what i want to see from the fda. and that's what tony fauci is talking about, moving quickly but not rushing. do all the due diligence. i think if left to their own natural instincts,...
44
44
Sep 4, 2020
09/20
by
CSPAN
tv
eye 44
favorite 0
quote 0
safeguards that the fda could employ that would allow the public to be reassured about a potential eua for a vaccine. host: another question for you -- window vaccine -- when a vaccine is eventually produced, what do you expect to be the rate of americans who actually take it? there was a gallop poll -- gallup poll that came out recently, from july 20 to august 2, where 65% of people said they would take an fda approved vaccine, but 35%, more than a full third of people in that poll, said they would not take an fda approved vaccine. what is the concern about whether people will actually take a vaccine or not, and -- or not once it is produced? guest: people have
safeguards that the fda could employ that would allow the public to be reassured about a potential eua for a vaccine. host: another question for you -- window vaccine -- when a vaccine is eventually produced, what do you expect to be the rate of americans who actually take it? there was a gallop poll -- gallup poll that came out recently, from july 20 to august 2, where 65% of people said they would take an fda approved vaccine, but 35%, more than a full third of people in that poll, said they...
116
116
Sep 2, 2020
09/20
by
CNNW
tv
eye 116
favorite 0
quote 0
i've been through a number of vaccine trials in which euas have ultimately been done and they've been done that there is enough data that you would feel comfortable that it was safe and effective for the american public. >> dr. fauci has been very consistent about this, john. back in january, he said, elizabeth, 12 to 18 months until we can have a vaccine, and he's said that over and over again. 12 months from january would be the end of this year. note that he did not say november 3rd. he did not say by election day and you might think, november 3rd, december 31st whatever, and in a vaccine trial of this kind from november 3rd to december 31st that is a big chunk of time. >> that may be another issue. the president said yesterday he disagrees with dr. fauci a lot and that could be another disagreement. elizabeth cohen grateful for the insights. thank you very much. >>> open classroom windows on chilly days to the wrinkles of our new normal. it's a reflection of research that air flow is absolutely critical. if people are going to be in one location for extended periods even if corona
i've been through a number of vaccine trials in which euas have ultimately been done and they've been done that there is enough data that you would feel comfortable that it was safe and effective for the american public. >> dr. fauci has been very consistent about this, john. back in january, he said, elizabeth, 12 to 18 months until we can have a vaccine, and he's said that over and over again. 12 months from january would be the end of this year. note that he did not say november 3rd....
288
288
Sep 1, 2020
09/20
by
CNNW
tv
eye 288
favorite 0
quote 0
i was looking into this today, this eua process has not been around that long. back in 2009, it was considered and i can show you some of the data here. there was concerns about an euv for a vaccine. when you actually broke it down you found people are most comfortable if they are getting this information about the vaccine that benefits from their own doctor specifically as supposed to -- opposed to hear from the government. they thought about it again in 2009 and 2005 for anthrax. this would be a big move. >> what's the difference between an emergency youth authorization and a full vaccine approval? >> with authorization you are basically saying look, we got no other choices here, okay? we are conducting a risk-analysis and we are thinking we got to do this because there are no alternatives. i looked up the language here. the language is important. what they are saying is the fda to issue an eua, there must be no adequate approve or available alternative alternative. the thing is everybody wants a vaccine. the alternative which frankly has worked in many countr
i was looking into this today, this eua process has not been around that long. back in 2009, it was considered and i can show you some of the data here. there was concerns about an euv for a vaccine. when you actually broke it down you found people are most comfortable if they are getting this information about the vaccine that benefits from their own doctor specifically as supposed to -- opposed to hear from the government. they thought about it again in 2009 and 2005 for anthrax. this would...
47
47
Sep 16, 2020
09/20
by
CSPAN3
tv
eye 47
favorite 0
quote 0
in october, and again, these are conservative mats based on what we know as euas and what we know the manufacturing will be. in october, we're looking at somewhere in the neighborhood of 125 to 135 million tests available. that doesn't mean they'll be done. but these will be easily and readily available and the majority of them, we really hit that inflection point, will be point of care. >> good. >> mf of thep will be the buy next that we talked about. that will be made at approximately 48 to 50 million per month. again, $5 tests. 15-minute result. no instrument. very, very important. but we're starting to see the point of care coming from the shark tank, really hit iting th streets, so the next generation sequencing. the micro fluidics like fluidime and some advanced point of care are all starting to hit from shark tank. >> and i think you said in your testimony that sometime this month, we will have passed the first hundred million tests that people have taken. is that right? >> yes, sir, today's total of about a 5:00 this morning was 99.3 million tests having been performed in the
in october, and again, these are conservative mats based on what we know as euas and what we know the manufacturing will be. in october, we're looking at somewhere in the neighborhood of 125 to 135 million tests available. that doesn't mean they'll be done. but these will be easily and readily available and the majority of them, we really hit that inflection point, will be point of care. >> good. >> mf of thep will be the buy next that we talked about. that will be made at...
74
74
Sep 23, 2020
09/20
by
MSNBCW
tv
eye 74
favorite 0
quote 1
the statutory definition for an eua or authorization is different, of course, than it is for an approval. we're following those criteria. with respect to our performance during covid-19, i want to give a few examples. in fact, you're correct. fda does represent the gold standard. our scientists are incredible. they've done really remarkable work here. one of the major things that distinguishes us from other regulatory agencies around the world is we actually look at the primary data. we don't just look at a paper, we don't look at a press release. we look at the primary data, our scientists analyze that data and we draw conclusions from that data. we did that with remdesivir, we did that with convalescent plasma. we're doing that with tests. those are the sort of things that fda does that i believe represent the gold standard and allow us to have great confidence in the decisions that our career scientists are making. >> dr. hahn, would it be appropriate to say that the clinical trials, phase three clinical trials that are currently going on for now four manufacturers -- i think the four
the statutory definition for an eua or authorization is different, of course, than it is for an approval. we're following those criteria. with respect to our performance during covid-19, i want to give a few examples. in fact, you're correct. fda does represent the gold standard. our scientists are incredible. they've done really remarkable work here. one of the major things that distinguishes us from other regulatory agencies around the world is we actually look at the primary data. we don't...
57
57
Sep 9, 2020
09/20
by
CSPAN2
tv
eye 57
favorite 0
quote 0
but the rules for eua are really quite loose in the sense of being able to say that has to be a chance of efficacy. there was a bit of a discussion back and forth about how tight those date data were to indicae that. at the end of the day when the randomized placebo-controlled trials come up with results we are going to do with the right answer is. >> and finally, dr. fauci, we have just a couple of minutes. when we think about americans are going to most need a vaccine, clearly front-linee workers, people with compromised immune systems, perhaps the elderly, how do you think about that, and is that all decided right now about what groups of americans need to get the vaccine first? >> that is decided by an advisory committee on immunization practices which reports to the cdc. ultimately the cdc is involved in the final responsibility of distribution. this year the national academy of medicine, whose recommendation came up literally a day or two ago, is called in to complement that decision-making process. and as you said i think you called it correctly, it's not unexpected that front-l
but the rules for eua are really quite loose in the sense of being able to say that has to be a chance of efficacy. there was a bit of a discussion back and forth about how tight those date data were to indicae that. at the end of the day when the randomized placebo-controlled trials come up with results we are going to do with the right answer is. >> and finally, dr. fauci, we have just a couple of minutes. when we think about americans are going to most need a vaccine, clearly...
71
71
Sep 30, 2020
09/20
by
CNBC
tv
eye 71
favorite 0
quote 0
. >> regeneron drug helps threat covid-19 in early stages preliminary results could produce an eua fromhe fda that may allow the drug to be prescribed the company's cofounder and chief scientific officer will join "squawk box" this morning at 7:20 a.m. eastern time. >> micron expects to see significant sales hit this quarter d quarter primarily due to shipments to huawei. shares off 4.5% pre-market >>> still on deck, the nearly 20 year wait is over on wall street as the once secret palantir takes off today. we'll speak to one investor. . >>> welcome back to "worldwide exchange." indoor dining is resuming in new york city today. the move comes more than six months after the eateries were forced to shut down. many were forced to shift their entire business models many with outdoor dining and indoor dining set at 25% these places are facing their make or break moments. with our guest, flip siggy a filipino taqueria, are you optimistic about the given restraints >> with my restaurants, 25% capacity means two or three people the amount of labor it will take and costs sand safety of the staff
. >> regeneron drug helps threat covid-19 in early stages preliminary results could produce an eua fromhe fda that may allow the drug to be prescribed the company's cofounder and chief scientific officer will join "squawk box" this morning at 7:20 a.m. eastern time. >> micron expects to see significant sales hit this quarter d quarter primarily due to shipments to huawei. shares off 4.5% pre-market >>> still on deck, the nearly 20 year wait is over on wall street...
17
17
Sep 27, 2020
09/20
by
CSPAN
tv
eye 17
favorite 0
quote 0
eua,e we were to issue a fda would have to determine among other things the statutory standard is met we expect that this would be demonstrated based on adequate manufacturing data to ensure vaccine's quality and consistency and data from at least one well-designed phase three clinical trial that demonstrates safety and efficacy in a clear and compelling manner. let me emphasize that again. data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner. eua wouldxpected and include a follow-up to monitor safety among the visual -- individuals who receive the vaccine. fda will not authorize or approve a vaccine we would not feel comfortable giving to our families. 17,000 plus the employees of the fda, i want to make the following commitment today to the american public and in committee. fda will not authorize or approve any covid-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness. decisions to authorize or approve any vaccine or therapeutic will be made by the dedicated
eua,e we were to issue a fda would have to determine among other things the statutory standard is met we expect that this would be demonstrated based on adequate manufacturing data to ensure vaccine's quality and consistency and data from at least one well-designed phase three clinical trial that demonstrates safety and efficacy in a clear and compelling manner. let me emphasize that again. data from at least one well-designed phase three clinical trial that demonstrates its safety and efficacy...
112
112
Sep 4, 2020
09/20
by
CNNW
tv
eye 112
favorite 0
quote 0
they are not going to submit for eua. they are going to say we think this is good to go. send it to the fda. fda is still the organization that decides on this. this is an influential panel. they are made up of scientists, people looking at the epidemiology of a particular area. it is an important group of people and that will be an important date. i hope they share the data with the broad public. >> i would like you to look. i would feel more comfortable if you get a look at the data and other scientists do as well. >> thank you all. >>> next, what was said by joe biden after visiting the blake family. >>> and the kremlin, what sounds and looks a lot like the trump campaign. ound the country. with massive capacity, it's like an eight lane highway compared to a two lane dirt road. 25x faster than today's 4g networks. in fact, it's the fastest 5g in the world. from the network more people rely on. this is 5g built right. only on verizon. feepowerful 24-hour,f claritin non-drowsy, allergy relief, plus an immediate cooling sensation for your throat. feel the clarity, and liv
they are not going to submit for eua. they are going to say we think this is good to go. send it to the fda. fda is still the organization that decides on this. this is an influential panel. they are made up of scientists, people looking at the epidemiology of a particular area. it is an important group of people and that will be an important date. i hope they share the data with the broad public. >> i would like you to look. i would feel more comfortable if you get a look at the data and...
397
397
Sep 5, 2020
09/20
by
CNNW
tv
eye 397
favorite 0
quote 0
>> remember that the eua invoked the convalescent plasma over sold data not put out by a pharmaceutical company. they are in the interests of putting out a vaccine that's safe and effective but more importantly that people will take. we want to make sure we don't take press releases or public statements for data and science and look for the research behind why they are out. we need to be critical, everybody does, about the science we're being told. unfortunately we can't trust all of the messaging coming out of the podium. >> we will be all doing our own research. dr. derek hass, thank you so much. >>> election day is less than two months away. coming up, dr. jill biden goes after education secretary betsy devos and the trump administration. >> we are in donald trump's america and there's just so much chaos. and i feel that, you know, educators don't know what to do, students don't know what to do. we've got the retinol that gives you results in one week. not just any retinol. accelerated retinol sa. one week is all it takes. neutrogena®. you can't claim that because it's inanimate! [ s
>> remember that the eua invoked the convalescent plasma over sold data not put out by a pharmaceutical company. they are in the interests of putting out a vaccine that's safe and effective but more importantly that people will take. we want to make sure we don't take press releases or public statements for data and science and look for the research behind why they are out. we need to be critical, everybody does, about the science we're being told. unfortunately we can't trust all of the...
141
141
Sep 18, 2020
09/20
by
FBC
tv
eye 141
favorite 0
quote 0
and once they check out the efficacy and the safety of those vaccines, then we go to the fda for an euaart being able to administer the vaccines. what is not said about that is that the president drove this really hard with operation warp speed so that right now we are manufacturing at rusk. that means -- at risk. that means today we are manufacturing vaccines that we hope will work as we go there so they're immediately available when the data modelizatuon board says it's ready to go. he has driven that. he's been very, very positive about it, very upbeat about it. this is the kind of leader that you want. you want somebody that has a very positive approach. you want this in the government, you want this in the military, you want it in the business world. you want somebody who drives the solutions and is positive about it. lou: yeah. yeah, and it's, it is, it's becoming something of a pattern with the left, and, if you will, the permanent bureaucracy. you talked about your long association with her. this is, this is sort of par for the course, it seems these days, those willing to sell
and once they check out the efficacy and the safety of those vaccines, then we go to the fda for an euaart being able to administer the vaccines. what is not said about that is that the president drove this really hard with operation warp speed so that right now we are manufacturing at rusk. that means -- at risk. that means today we are manufacturing vaccines that we hope will work as we go there so they're immediately available when the data modelizatuon board says it's ready to go. he has...
124
124
Sep 23, 2020
09/20
by
CNBC
tv
eye 124
favorite 0
quote 1
scenario and then the fact that it would take the fda at least two to four weeks to turn around an euan eua for this vaccine isn't going to look like an approval, it's going to look like the continuation of the clinical trials where we make it available for a select group of patients and continue to collect data in a registry. >> you get it into the arms of people who need it, jim, the most early on. but, again, we come back to, what, mid 2021 for when we really can expect more broad inoculation. >> well, you can't -- where are you going to get covid right now? are you going to search for covid? we need to have people have regular lives, half the arms are the wrong thing anyway, right, in the placebo, don't be in a real hurry to get that but we don't know there are a lot of tests going on and that's good, but of all the things that i've heard, even more than j & j, it was david ricks on "mad money" on monday that you can talking about the therapeutic that when there is an outbreak of covid at a nursing home, remember, 40% of the people who have died of the 200,000 are nursing homes. th
scenario and then the fact that it would take the fda at least two to four weeks to turn around an euan eua for this vaccine isn't going to look like an approval, it's going to look like the continuation of the clinical trials where we make it available for a select group of patients and continue to collect data in a registry. >> you get it into the arms of people who need it, jim, the most early on. but, again, we come back to, what, mid 2021 for when we really can expect more broad...
116
116
Sep 2, 2020
09/20
by
CNNW
tv
eye 116
favorite 0
quote 0
. >> i've been through a number of vaccine trials in which euas have been done but they've been done when there was enough data that you would really feel comfortable it was safe and effective for the american public. >> as you know, doctor, the american public has to feel it's safe and effective. would you be comfortable with fast-tracking a vaccine? >> depends on the data. we need to see the data openly and the fda has said they'll provide all the data openly. is it effective? does it work? is it safe? and will people take it? in terms of the safety, that's a complicated question. because sometimes you don't find a problem with the vaccine until tens or hundreds have been vaccinated. that means not only do you need to start carefully, but you need to monitor over time. we already have too much distrust in vaccines. we need complete openness about what's going on with the vaccine, an assurance it's not politicized and an understanding that decisions are made with one concept only. how do we save american lives. >> i want to talk to you about something joni ernts has suggested, that
. >> i've been through a number of vaccine trials in which euas have been done but they've been done when there was enough data that you would really feel comfortable it was safe and effective for the american public. >> as you know, doctor, the american public has to feel it's safe and effective. would you be comfortable with fast-tracking a vaccine? >> depends on the data. we need to see the data openly and the fda has said they'll provide all the data openly. is it...
99
99
Sep 25, 2020
09/20
by
CNNW
tv
eye 99
favorite 0
quote 0
. >> the scientists and the fda have put this forth as what they're proposing for the criteria of eua. under normal circumstances that decision is theirs, the secretary approves it and that's t. something that comes from without that is not a scientific consideration would be troublesome. >> reporter: health and human services secretary alex a czar batting cleanup. >> politics will play no role whatsoever in a vaccine. science will drive this. fda is going to make the call on whether a vaccine is safe and effective. >> reporter: antibody tests that can be administered in a doctor's office as new information suggests the virus is becoming more contagious though not more lethal. the cdc reports more than 20% of confirmed cases between june and august where people in their 20s. >> the only way we're going to end this is if everybody pulls together. >> reporter: officials in colorado banned all gatherings from 18 to 22. colorado is one of the few states seeing cases rise over the past week. >> what you're seeing is an inconvenient truth which is many states allowed schools and colleges to
. >> the scientists and the fda have put this forth as what they're proposing for the criteria of eua. under normal circumstances that decision is theirs, the secretary approves it and that's t. something that comes from without that is not a scientific consideration would be troublesome. >> reporter: health and human services secretary alex a czar batting cleanup. >> politics will play no role whatsoever in a vaccine. science will drive this. fda is going to make the call on...
83
83
Sep 15, 2020
09/20
by
MSNBCW
tv
eye 83
favorite 0
quote 0
united states by the end of october gates said if there was vaccine maker that has a chance of seeking euan it would be pfizer. turning now to our breaking news, hurricane sally is taking aim at the gulf coast and moving a dangerously slow pace, dumping heavy rainfall along the southeastern part of the united states, historic flooding is possible with what the national hurricane center calls extreme life-threatening flash flooding. joining me now is the director of the national hurricane center, ken graham thank you so much for joining us what's the latest on hurricane sally's track? >> yeah, the latest information, we're getting all the latest information from the aircraft, 80 miles per hour. you start looking at the, slowly you move, the dangerous rainfall and to push those tides in, slow is not a good in, slow system, just 2 miles an hour. >> one of the things that we've been tracking that there are actually five storms brewing in the atlantic, including tropical storm teddy which is expected to become a hurricane, how concerning is it to you guys down there that all of these storms are
united states by the end of october gates said if there was vaccine maker that has a chance of seeking euan it would be pfizer. turning now to our breaking news, hurricane sally is taking aim at the gulf coast and moving a dangerously slow pace, dumping heavy rainfall along the southeastern part of the united states, historic flooding is possible with what the national hurricane center calls extreme life-threatening flash flooding. joining me now is the director of the national hurricane...
126
126
Sep 4, 2020
09/20
by
CNNW
tv
eye 126
favorite 0
quote 0
we saw it with the sunday night preconvention, announcement of an eua for convalescent plasma, despiteih was counseling against doing that. and then the fda commissioner sort of misrepresent the data that night. so, we've seen politics, pressure, decision makers to do this. fortunately the fda is populated by really wonderful, brilliant, world class scientists and staff members, who will push back. but they're going to be under tremendous amount of pressure to give the president some sort of late october surprise prior to the election. >> let's talk about the projections we're seeing for the months ahead. there's a new model that they're using and they're using the data on how americans are currently behav behaving and saying 410,000 will die by the start of the new year, but if there were universal mask use, that number would go down by 122,000 people. so, i think we know what the take away is here, right? butt but how do you actually get americans to take that information and operationalize it? >> it would be helpful if we didn't have leaders that brought 200,000 people together on t
we saw it with the sunday night preconvention, announcement of an eua for convalescent plasma, despiteih was counseling against doing that. and then the fda commissioner sort of misrepresent the data that night. so, we've seen politics, pressure, decision makers to do this. fortunately the fda is populated by really wonderful, brilliant, world class scientists and staff members, who will push back. but they're going to be under tremendous amount of pressure to give the president some sort of...
40
40
Sep 4, 2020
09/20
by
CSPAN
tv
eye 40
favorite 0
quote 0
safeguards that the fda could employ that would allow the public to be reassured about a potential eua for a vaccine. host: another question for you -- window vaccine -- when a vaccine is eventually produced, what do you expect to be the rate of americans who actually take it? there was a gallop poll -- gallup poll that came out recently, from july 20 to august 2, where 65% of people said they would take an fda approved vaccine, but 35%, more than a full third of people in that poll, said they would not take an fda approved vaccine. what is the concern about whether people will actually take a vaccine or not, and -- or not once it is produced? guest: people have spent a great time thinking about this and figuring out how the scientific community can interact with the public to reassure them about vaccine -- about a vaccine. >> we are going to leave this program and go live to a role on -- to a discussion on the role of senate judges. >> welcome to our today. -- our even to -- our event today. in, let me make a couple of announcements and we will get right down to what we are here for.
safeguards that the fda could employ that would allow the public to be reassured about a potential eua for a vaccine. host: another question for you -- window vaccine -- when a vaccine is eventually produced, what do you expect to be the rate of americans who actually take it? there was a gallop poll -- gallup poll that came out recently, from july 20 to august 2, where 65% of people said they would take an fda approved vaccine, but 35%, more than a full third of people in that poll, said they...
458
458
Sep 29, 2020
09/20
by
CNNW
tv
eye 458
favorite 0
quote 0
so, we could start pretty quickly, almost immediately after an eua were granted, if it were to be grantedet's hope this works because it potentially could save a lot of people, a lot of problems from this coronavirus if it works. but it's still early, let's continue with your work as you always dr. doctor, thanks to regeneron for everything you're doing. sanjay, thanks as well. >>> president trump's war on voting. will he launch new attacks during tonight's debate? we'll be right back. and get matched with a customized plan. the assessment takes into account the things that matter to you the most. on my plan, whole wheat pasta and potatoes are zero points. on the app, we love the personalized recipes. we found so many new favorites! with 24/7 live coaching, you get connected to an amazing coach, who can answer any question that you might have. i lost 91 pounds. it's the best thing i could've ever done! join today and get a free ww cookbook bundle! plus you could win an amazon halo band! in the tubbs fire. the flames, the ash, it was terrifying. thousands of family homes are destroyed in w
so, we could start pretty quickly, almost immediately after an eua were granted, if it were to be grantedet's hope this works because it potentially could save a lot of people, a lot of problems from this coronavirus if it works. but it's still early, let's continue with your work as you always dr. doctor, thanks to regeneron for everything you're doing. sanjay, thanks as well. >>> president trump's war on voting. will he launch new attacks during tonight's debate? we'll be right back....
94
94
Sep 23, 2020
09/20
by
CNNW
tv
eye 94
favorite 0
quote 0
there was a lot of political pressure to approve a vaccine with an eua, and there was going to be no way to understand the safety of the vaccine. so it looks like they're going to want to look at at least two months of safety data, which effectively pushes any approval of a vaccine to probably back to at least december. i think it's a wise move. there is a lot of skepticism in this country about vaccine safety. there always has been, and there's more now that it seems a vaccine was pushed too quickly. i think it was a good move. >> andy, the president has been teasing a vaccine announcement as early as next month or before the election. could this decision by the fda help restore the public's confidence that the science isn't going to be overruled by competence? . >> the public should be confident in a vaccine. 800 kids died before a measles vaccine. we should be excited about the progress, but as dr. reiner, we should accelerate but not rush. if we get a vaccine out sometime during 2021, early in the year, middle of the year, it will be an incredible pace, it will be an incredible p
there was a lot of political pressure to approve a vaccine with an eua, and there was going to be no way to understand the safety of the vaccine. so it looks like they're going to want to look at at least two months of safety data, which effectively pushes any approval of a vaccine to probably back to at least december. i think it's a wise move. there is a lot of skepticism in this country about vaccine safety. there always has been, and there's more now that it seems a vaccine was pushed too...
92
92
Sep 5, 2020
09/20
by
MSNBCW
tv
eye 92
favorite 0
quote 0
been a little bit of a crisis of credibility that was really the government's own making, the revoked euanderstand when multiple or masses of people are concerned and wary about taking this vaccine given where we are, where we came from and where we're going. i will say we have to rely on the scientists to do their job. even the researchers conducting the trials are not monitoring this. this is going to be done by the data safety monitoring board with an independent panel. if they get to the end of stage three and they say this appears to be safe and we have demonstrated the vaccine is at least 50% effective, which is the benchmark they've chosen, i will get the vaccine. but i think i speak for a lot of my colleagues when i say we're not necessarily willing to cut corne corners. i don't think the scientists are either. the messaging from the white house is very different from the messaging from what should be the independent scientific bodies. there have been some slips and blunders and they really have to right the ship. otherwise it going 's going to challenging to convince people that
been a little bit of a crisis of credibility that was really the government's own making, the revoked euanderstand when multiple or masses of people are concerned and wary about taking this vaccine given where we are, where we came from and where we're going. i will say we have to rely on the scientists to do their job. even the researchers conducting the trials are not monitoring this. this is going to be done by the data safety monitoring board with an independent panel. if they get to the...
235
235
Sep 4, 2020
09/20
by
CNNW
tv
eye 235
favorite 0
quote 0
we have already seen walk-back on euas on therapeutics, the fda had to apologize when it came to the convalescent plasma for treating covid-19. are you concerned at all when it comes to political pressure for a vaccine and public trust once when is available? >> absolutely, i'm very concerned because we need to let the process occur the way it needs to. we are speeding up things. operation warped speed is working. we are speeding up things, we are not sleeping or resting. we went from discovering the virus to putting a virus in humans 65 days later. we need it completed because completed will take two years but we need to reach the -- we need to be able to show that this vaccine is effective and that's going to take whatever time it needs to take because again, at the same time we're trying to slow the transmission of this virus, so the more you slow the transmission the less likely you are to see infections. so you won't know -- let's suppose about the end of three months in the vaccinated group you see, you know, the people who got the vaccine you see one infection and the people w
we have already seen walk-back on euas on therapeutics, the fda had to apologize when it came to the convalescent plasma for treating covid-19. are you concerned at all when it comes to political pressure for a vaccine and public trust once when is available? >> absolutely, i'm very concerned because we need to let the process occur the way it needs to. we are speeding up things. operation warped speed is working. we are speeding up things, we are not sleeping or resting. we went from...
225
225
Sep 3, 2020
09/20
by
CNNW
tv
eye 225
favorite 0
quote 0
favorable that they say hey, look, we're sending this to the fda and they will make the decision about eua or not. that would be the sort of data that we're talking about here but it's just that's going to take time. i mean, that takes time and that board is an independent board but, you know, they have to be able to have the time to look at this data, probably have to look at the two doses given and follow these patients along for sometime to see if this isfective and to see if it's safe. so the basic thing that they are trying to find scientifically is the same but the passage of time is important to evaluate the data. >> professor hazeltine, i want to say what the president said about a vaccine timeline in recent months. let's listen. >> i'm rushing it. i am. i'm pushing everybody. if you had another president other than me, you wouldn't be talking vaccines for two years. >> we can see that, a vaccine? >> sooner than the end of the year, could be much sooner. >> sooner than november 3rd? >> i think in some cases, yes, possible before but right around that time. >> we're balancing speed
favorable that they say hey, look, we're sending this to the fda and they will make the decision about eua or not. that would be the sort of data that we're talking about here but it's just that's going to take time. i mean, that takes time and that board is an independent board but, you know, they have to be able to have the time to look at this data, probably have to look at the two doses given and follow these patients along for sometime to see if this isfective and to see if it's safe. so...
65
65
Sep 1, 2020
09/20
by
LINKTV
tv
eye 65
favorite 0
quote 0
the danger about the vaccine eua before phase three trial results are out is much more dire. we give treatments to the sick. in this case, many people were hospitalized. vaccines go to millions of people. we depend on them to be effective so people don't get the wrong impression about what they should be doing in terms of social distancing. we depend on them to be safe. a vaccine will be an important long-term way to control the virus, and we need public confnfidence in n vaccines.. craig covid, passive americans don't get vaccicinated with seasonal flu. we have seen outbreaks of other childhdhood diseasases because e have pockekets of people who are skeptics about vaccines. dr. hahn's willingness to play fast and loose with h the dadata when vaccine devevelopers, are terrirified they will get ahead of the data because the president wants octoberg by ththe end of so he can bring it into the electition week with him hoping for victory. this is threree strikes for the fda.a. hydroxychloroquine, convalescent eua.a, and the vaccine the nih director said today to --p this thing to
the danger about the vaccine eua before phase three trial results are out is much more dire. we give treatments to the sick. in this case, many people were hospitalized. vaccines go to millions of people. we depend on them to be effective so people don't get the wrong impression about what they should be doing in terms of social distancing. we depend on them to be safe. a vaccine will be an important long-term way to control the virus, and we need public confnfidence in n vaccines.. craig...
190
190
Sep 25, 2020
09/20
by
CNNW
tv
eye 190
favorite 0
quote 0
is that the scientists and the fda have put this forth as what their proposal for the criteria for eua circumstances, that decision is theirs, the secretary approves it, and that's it. something that comes from whiteout that is not a soon tifk consideration, would be troublesome. >> troublesome. politics and science at a political juncture. joining me now is dr. tom friedman, former cdc director. i assume you agree it's troublesome, but can the president do that? >> anderson, if you think about what makes a vaccine work, it has to be safe, effective, and trusted. and if they cut corners and stop a trial early to rush something into people's arms, we're not going to know whether it's safe. we're not going to know whether it's effective for all groups such as the elderly. and we're not going to have the trust in it that's needed to get it used. we all want there to be a vaccine available as soon and safely as possible. but if you look at what this administration has done with masks, when to close, when to open, what to do with schools, what you've seen is a per sis temperature a -- consi
is that the scientists and the fda have put this forth as what their proposal for the criteria for eua circumstances, that decision is theirs, the secretary approves it, and that's it. something that comes from whiteout that is not a soon tifk consideration, would be troublesome. >> troublesome. politics and science at a political juncture. joining me now is dr. tom friedman, former cdc director. i assume you agree it's troublesome, but can the president do that? >> anderson, if you...
96
96
Sep 23, 2020
09/20
by
FBC
tv
eye 96
favorite 0
quote 0
talking today, laying out the process, what is going to happen, how these vaccines will undergo whether euaa approval and guarantying the safety and efficacy of the vaccines if they get approved and that is crucial for the public to hear. connell: so say guess one way i would ask it in a hypothetical, if moderna is first to market, their vaccine is ready, would you recommend that you know, your family, your patients take that vaccine, or would you say to them, you know what? johnson & johnson is coming soon, let's wait for that? how would you, if someone asks you that question at the time how do you think you would answer it? >> i would take whichever fda approved vaccine is available first. if it underwent fda approval, that means it is proven safe and effective in human clinical trials. that being said, it is not one size fits all. you have to look at vaccinations when it comes to the individual. right now children are not being included in the clinical trials. i will not necessarily rush to get children vaccinated with the covid-19 vaccine until they undergo the pediatric trials. we have
talking today, laying out the process, what is going to happen, how these vaccines will undergo whether euaa approval and guarantying the safety and efficacy of the vaccines if they get approved and that is crucial for the public to hear. connell: so say guess one way i would ask it in a hypothetical, if moderna is first to market, their vaccine is ready, would you recommend that you know, your family, your patients take that vaccine, or would you say to them, you know what? johnson &...
94
94
Sep 10, 2020
09/20
by
CNNW
tv
eye 94
favorite 0
quote 0
the first antigen was approved and got an eua back in march. they should have gone into full rump-up testing so it could have gone into the schools tapped would have been much easier to get back to school this fall. i'm timely hopeful we've gotten our action as a nation together. the scientific community is very long and we can deliver the testing that the american people need but it's hard to do it without clear strong government support. >> hard tore do it if you have a president of the united states who says part of his strategy is deliberately to play it down to the american people. you need to create the urgency to act. dr. shaw, as always, thanks for your insights. i'm sure we'll continue this conversation. >>> up next, more on the conversations with bob woodward and as we go to break. her father supported the president and later died from the coronavirus. one daughter's emotional reaction to listening to the president in those conversations with woodward. >> it is a punch in the stomach for me and every single person who has either contr
the first antigen was approved and got an eua back in march. they should have gone into full rump-up testing so it could have gone into the schools tapped would have been much easier to get back to school this fall. i'm timely hopeful we've gotten our action as a nation together. the scientific community is very long and we can deliver the testing that the american people need but it's hard to do it without clear strong government support. >> hard tore do it if you have a president of the...
331
331
Sep 4, 2020
09/20
by
CNNW
tv
eye 331
favorite 0
quote 0
convalescent plasma as treatment and something that didn't have a full consensus about approving that eua and the president came out on a sunday with a big press conference talking about it and he brought the fda commissioner and hhs secretary and the fda commissioner had to walk back the statements overstating the benefits of what they were doing, overhyped it according to medical experts so you see how they're looking for any piece of good news and as a president you can understand why. but it's important that it's realistic and people know where we are and if we're going to have a vaccine by the end of obje october like the president said last night. it's just two different messages and people want to have a realistic timeline of when there could be a vaccine. >> and it's stunning to the degree if you subscribe to the theory of the president doing things in his interest, if he would get the case count down closer to the election it is in his interest and will not speak up and urge the governors to do more with the shhotspots. the president believed the u.s. economy is rounding a corner
convalescent plasma as treatment and something that didn't have a full consensus about approving that eua and the president came out on a sunday with a big press conference talking about it and he brought the fda commissioner and hhs secretary and the fda commissioner had to walk back the statements overstating the benefits of what they were doing, overhyped it according to medical experts so you see how they're looking for any piece of good news and as a president you can understand why. but...
123
123
Sep 15, 2020
09/20
by
CNNW
tv
eye 123
favorite 0
quote 0
that even if a coronavirus vaccine gets a quick approval through the emergency use authorization, the euaan there will be fast or wide deployment. why not? >> well, part of that has to do with what they can already start to manufacture and what they will have manufactured by the end of the year. and just to be clear, approval different than authorization. emergency use authorization is the first sort of thing that they may get. it may be some time within the next few months. approval, mostly vaccinemakers will still try and obtain months down the line. nick's right, there is no distribution sort of plan here. but they do have an idea of who would get vaccinated first. essential workers, 9 million health care workers, 15 million other essential workers. jake, that's sort of the supply for this year roughly, maybe a few extra million doses beyond that. but it's going to take a while to get the rest of the country vaccinated or even to get to that 60 to 70% of the country that would be required for that herd immunity. >> bill gates has called the u.s. response shocking and mismanaged. take a
that even if a coronavirus vaccine gets a quick approval through the emergency use authorization, the euaan there will be fast or wide deployment. why not? >> well, part of that has to do with what they can already start to manufacture and what they will have manufactured by the end of the year. and just to be clear, approval different than authorization. emergency use authorization is the first sort of thing that they may get. it may be some time within the next few months. approval,...