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Sep 12, 2020
09/20
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that the fda, for those with confidence, they need to be able to trust the toentific experts at the fda act independently and make those decisions based on the science. that's important and any pressure on the fda from outside needs to stop if people want to trust the vaccines. i am very sympathetic to getting it quickly, everybody wants that . but as polling has shown, the ableity people want to be to have that process be done in that ensures that vaccines are is this -- as safed and effective -- as safe and effective as could be. if we want to vaccine, which we all want to help and the pandemic, people need to be able .o trust the recommendations the fda has said it will stick to the science. when there's pressure people become skeptical. this is important to address in the upcoming month. the fda need to be really transparent about the data it and it any approvals and aergency authorizations to public advisory committee. that will help. but i think some damage has been done to the public trust. host: once a vaccine is available, will it be cost prohibitive for some people? i think th
that the fda, for those with confidence, they need to be able to trust the toentific experts at the fda act independently and make those decisions based on the science. that's important and any pressure on the fda from outside needs to stop if people want to trust the vaccines. i am very sympathetic to getting it quickly, everybody wants that . but as polling has shown, the ableity people want to be to have that process be done in that ensures that vaccines are is this -- as safed and effective...
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Sep 23, 2020
09/20
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MSNBCW
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fda represents science in action. make realtime decisions based on ever-evolving data concerning a previously unknown highly contagious virus that we're still learning about. sometimes it is necessary to reverse decisions as new data emerge. this is inherent in the emergency use authorization process, otherwise known as eua, and it is akin to how a doctor might 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 three 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 criter
fda represents science in action. make realtime decisions based on ever-evolving data concerning a previously unknown highly contagious virus that we're still learning about. sometimes it is necessary to reverse decisions as new data emerge. this is inherent in the emergency use authorization process, otherwise known as eua, and it is akin to how a doctor might approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge. so in the interest of...
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Sep 23, 2020
09/20
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CSPAN3
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eye 31
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or look at the fda. congress provided fda with specific authorities beginning in 2004, 16 years ago to issue emergency use authorizations for test, treatments and vaccines to respond to public health emergencies. dr. han has used that authority. fda has used that authority to authorize 250 tests and five treatments as quickly as possible and also to remove tests and treatments when additional evidence showed they didn't work as well as they should, or look at barta. congress established the biomedical advanced research authority in 2006, 14 years ago to help companies work to get fda safe and effective vaccines out. barta was able to announce awards for potential covid-19 treatment of vaccine candidates just over one month after the vaccine was first reported in china. as i said earlier four of the first six vaccines are being manufactured in facilities built in 2012 for this purpose, for a future pandemic. and then there's been federal support over the years for state, local and hospital preparedness. $
or look at the fda. congress provided fda with specific authorities beginning in 2004, 16 years ago to issue emergency use authorizations for test, treatments and vaccines to respond to public health emergencies. dr. han has used that authority. fda has used that authority to authorize 250 tests and five treatments as quickly as possible and also to remove tests and treatments when additional evidence showed they didn't work as well as they should, or look at barta. congress established the...
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Sep 23, 2020
09/20
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CNNW
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eye 121
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fda represents science in action.ake realtime decisions based on ever-evolving data concerning a previously unknown, highly contagious virus that we are still learning about, and sometimes it is necessary to reverse decisions as new data emerge. this is inherent in the emergency use authorization process otherwise known as eua and it is akin to how a doctor might 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 represents science in action.ake realtime decisions based on ever-evolving data concerning a previously unknown, highly contagious virus that we are still learning about, and sometimes it is necessary to reverse decisions as new data emerge. this is inherent in the emergency use authorization process otherwise known as eua and it is akin to how a doctor might approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge. so in the interest of...
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Sep 27, 2020
09/20
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CSPAN
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or look at the fda. congress provided that they specific authorities beginning in 2004, 16 years ago, to review and issue emergency authorization for tests, treatment and vaccinations to respond. doctor hahn has used that authority and the fda has used that authority to authorize 250 tests and find treatments as quickly as possible and remove tests and treatments when evidence shows they didn't work as well as they should. the congress established the biomedical advanced research development of a ready in mid mid-2006, 14 years ago, to help companies work with fda for treatment and vaccines. they were able to award candidates just over one month after the vaccine was first reported in china. as i said earlier, four of the first are being manufactured and facilities built in 2012 for this purpose, for a future pandemic. vendors can support over the years the state, local and hospital preparedness, $21 billion between 2002 and 2017. the cbc has used existing programs to help states retrain workforces expan
or look at the fda. congress provided that they specific authorities beginning in 2004, 16 years ago, to review and issue emergency authorization for tests, treatment and vaccinations to respond. doctor hahn has used that authority and the fda has used that authority to authorize 250 tests and find treatments as quickly as possible and remove tests and treatments when evidence shows they didn't work as well as they should. the congress established the biomedical advanced research development of...
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Sep 23, 2020
09/20
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CNNW
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eye 126
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i totally am with the fda. and they're putting forward the highest possible standards for safety and efficacy of the new vaccines being tested right now in phase three including one that just started today which we're pretty excited about. we do not want the public to trust that these are something they'd want to endorse or roll up their sleeves for without having that data. that is why these are some of the largest phase three trials ever run and why they also are looking very carefully to be sure they're safe. and i think fda is on a very good path right now and they are determined to stick to that as you heard in the hearing today from dr. hahn. >> we wanted, all of us want a vaccine as quickly as possible. we want to make sure it is safe and no very serious side effects not just for adults but for children, elderly people, and people who have underlying health conditions. everybody has to trust this vaccine as you know the nih announced the launch of another phase three trial of the, what is called the jans
i totally am with the fda. and they're putting forward the highest possible standards for safety and efficacy of the new vaccines being tested right now in phase three including one that just started today which we're pretty excited about. we do not want the public to trust that these are something they'd want to endorse or roll up their sleeves for without having that data. that is why these are some of the largest phase three trials ever run and why they also are looking very carefully to be...
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Sep 4, 2020
09/20
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CNNW
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send it over to the fda. fda is still the one -- fda is still the organization that decide on this. but this is an influential panel. it's usually people who are made up of scientists, people looking at the epidemiology of a particular area. so, you know, it's a very important, you know, group of people and that will be a very important date. i do hope that they share this data with the broad public. i mean, i'd like to look at the data. i know a lot of other people would as well. >> i'd like you to look at the data. i'd feel much more comfortable if you got a good look at this data and other scientists as well. thank you all for being with us. next, some of what joe biden said after speaking with jacob blake during his visit to wisconsin. blake family attorney, benjamin crump, joins us. and later, more breaking news on kremlin campaign interference that looks and sounds a lot like a central focus of president trump's campaign. hey allergy muddlers... achoo! ...do your sneezes turn heads? try zyrtec... ...it starts working hard at hour one... and works twice as hard when you take it
send it over to the fda. fda is still the one -- fda is still the organization that decide on this. but this is an influential panel. it's usually people who are made up of scientists, people looking at the epidemiology of a particular area. so, you know, it's a very important, you know, group of people and that will be a very important date. i do hope that they share this data with the broad public. i mean, i'd like to look at the data. i know a lot of other people would as well. >> i'd...
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Sep 10, 2020
09/20
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CSPAN
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defunding the who, the fda fast tracked testing. andot tests that were worse so inaccurate that you are better off not taking a test. the cdc should have been running and shouldesponse have been pointing it from the get-go. we did not like pyeongchang -- fauchi, so we will find someone else. after all is said
defunding the who, the fda fast tracked testing. andot tests that were worse so inaccurate that you are better off not taking a test. the cdc should have been running and shouldesponse have been pointing it from the get-go. we did not like pyeongchang -- fauchi, so we will find someone else. after all is said
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Sep 27, 2020
09/20
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CSPAN2
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through a series of events he decides to blow the whistle to take this explosive information to the fdas an eight year investigation and the action surrounding this serve the narrative of the lives. it might surprise people to know this but 90 percent is generic so if you go to a pharmacy will certainly the prescription you get is generic even more surprising is almost 80 percent of the active ingredient of all drugs are being manufactured overseas principally china and india and the majority of finished toast generic also come from overseas 40 percent alone are made in namibia now with fda regulations any manufacturing plant that extensor drugs into the us market has to be inspected by the fda so on paper the system of regulation is identical but the reality is when the fda expects - - inspects plans they show up unannounced and stay as long as needed but because of the logistics of overseas inspections the fda announces its coming months in advance for overseas inspections that gives manufacturing plants the opportunity to clean up which they do i expose how they send data fabrication
through a series of events he decides to blow the whistle to take this explosive information to the fdas an eight year investigation and the action surrounding this serve the narrative of the lives. it might surprise people to know this but 90 percent is generic so if you go to a pharmacy will certainly the prescription you get is generic even more surprising is almost 80 percent of the active ingredient of all drugs are being manufactured overseas principally china and india and the majority...
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Sep 24, 2020
09/20
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CNNW
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fda will not permit any pressure to change that. >> reporter: the fda works to boost confidence in a vaccine, even considering tougher standards for emergency use authorization. the president's reaction -- >> extremely political. why would they do that when we come back with these great results and ultimately the white house has to approve it. >> reporter: dr. fauci noting that's not the traditional route. >> the scientists and the fda have put this forth as to what their proposal for the criteria for them. under normal conditions, that decision is there, the secretary approves it, and that's it. something that comes from without, that is not a scientific consideration would be troublesome. >> reporter: health and human services secretary alec azar batting cleanup. >> will play no role whatsoever. i've been clear, the president has been clear, science will drive this. fda will make the call on whether the vaccine is effective. >> reporter: new information suggests the virus is becoming more contagious, though not more lethal. the cdc reports more than 20ch of confirmed cases between
fda will not permit any pressure to change that. >> reporter: the fda works to boost confidence in a vaccine, even considering tougher standards for emergency use authorization. the president's reaction -- >> extremely political. why would they do that when we come back with these great results and ultimately the white house has to approve it. >> reporter: dr. fauci noting that's not the traditional route. >> the scientists and the fda have put this forth as to what...
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Sep 24, 2020
09/20
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CNNW
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fda will not permit any pressure from anyone to change that. >> a straightforward pledge as the fda worksnce in a vaccine even standards for emergency use authorization. >> extremely political. why would they do this. we come back with great results and ultimately the white house has to prove it. >> we don't need an election day vaccine. we need a safe, effective and trustworthy vaccine. >> alex azar batting cleanup. >> politics will play no role whatsoever in the approval of a vaccine. the president has been clear, i've been clear, fda has been clear, science will drive this. fda will make the call whether a vaccine is safe and effective. >> new information suggesting the virus became more contagious but not more lethal as cdc reports 20% of cases between june and august were people in their 20s. >> the only way we're going to end this is if everybody pulls together. >> officials in colorado banned all gatherings, even outdoors for everyone 18 to 22 in boulder. colorado is among 21 states seeing new cases rise over the past week. >> we squandered our mer. we went into the summer with 20,
fda will not permit any pressure from anyone to change that. >> a straightforward pledge as the fda worksnce in a vaccine even standards for emergency use authorization. >> extremely political. why would they do this. we come back with great results and ultimately the white house has to prove it. >> we don't need an election day vaccine. we need a safe, effective and trustworthy vaccine. >> alex azar batting cleanup. >> politics will play no role whatsoever in the...
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Sep 23, 2020
09/20
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it's something that fda has been involved with for years. with respect to the issue of medications, for example, and ppe, i know the white house task force has been particularly focused through fema and now hhs on making sure we build up our domestic capacity, particularly around ppe. yes, those are in progress. it remains a top priority for the food and drug administration. our role in this will be to help to create whatever regulatory pathway we can so we can facilitate advanced manufacturing that's domestic. >> thank you very much. >> thank you, senator collins. senator warren. >> thank you, mr. chairman. vaccines are our best chance to end this best chance to end this pandemic but americans are not going to take a vaccine if they don't trust the federal officials who are promoting it. if federal officials stand to gain financially from certain covid vaccines and not from others, then americans might reasonably worry that the vaccine was pushed for personal profit and not because it was best for our health. so i have a question for all of
it's something that fda has been involved with for years. with respect to the issue of medications, for example, and ppe, i know the white house task force has been particularly focused through fema and now hhs on making sure we build up our domestic capacity, particularly around ppe. yes, those are in progress. it remains a top priority for the food and drug administration. our role in this will be to help to create whatever regulatory pathway we can so we can facilitate advanced manufacturing...
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Sep 23, 2020
09/20
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ed fda is responsibility for depending if a vaccine is safe. if the fda had financial conflicts, your opinion, would that increase or decrease people's confidence in a covid-19 vaccine? >> senator, i'm not aware of anyone at fda that has a conflict related to vaccines involved in that decision-making process. it would be difficult for me to speculate on that since we have very rigorous standards in place. we have monthly review, particularly of senior officials. we have regular training, and we have a culture at fda which looks at the issue of self-declared as well as office of government ethics review of all conflicts. senator, i'd like to say if anyone is aware at fda with a conflict represented to these i would personally want to know because we will address that right away. >> i very much appreciate this. you're saying that financial conflicts are a real problem in the drug and vaccine development process. but here's the problem we've got. dr. manseth slowey, the man that president trump selected as the government's "vaccine czar" is is a f
ed fda is responsibility for depending if a vaccine is safe. if the fda had financial conflicts, your opinion, would that increase or decrease people's confidence in a covid-19 vaccine? >> senator, i'm not aware of anyone at fda that has a conflict related to vaccines involved in that decision-making process. it would be difficult for me to speculate on that since we have very rigorous standards in place. we have monthly review, particularly of senior officials. we have regular training,...
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Sep 24, 2020
09/20
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KGO
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president trump is threatening to overrule the fda if he doesn't approve of the fda's tougher guidelinesa potential vaccine. dr. anthony fauci saying tonight i would back the scientists and now the states this evening where they say they'll have their own review of the vaccine. here's mary bruce. >>> after touting the coronavirus vaccine by election day, president trump is threatening to reject stricter safety standards that could slow down its release, once again, undermining his own health officials. >> i'll tell you what, we are looking at that. and that has to be approved by the white house. we may or may not approve it. that sounds like a political move. >> reporter: tonight, four vaccines are in their final trials. but new rules from the fda would reportedly require drug makers to monitor trial volunteers for an additional two months. dr. anthony fauci coming to the fda's defense. >> if they look at it and say we really feel strongly we should go this way, i would back the scientists. i would have to do that as a scientist. >> reporter: fauci said they may not need the additional m
president trump is threatening to overrule the fda if he doesn't approve of the fda's tougher guidelinesa potential vaccine. dr. anthony fauci saying tonight i would back the scientists and now the states this evening where they say they'll have their own review of the vaccine. here's mary bruce. >>> after touting the coronavirus vaccine by election day, president trump is threatening to reject stricter safety standards that could slow down its release, once again, undermining his own...
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Sep 23, 2020
09/20
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FOXNEWSW
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until fda approves it.illing to take that vaccine for you and for your family? >> absolutely yes, senator. mr. chairman. i have the complete and absolute faith in the expertise of the scientists who are terrific at fda. if they were to make a determination that a vaccine would be safe and effective i would do that and i would encourage my family to take it. >> dr. fauci you've seen lots of diseases, pandemics and responses to it. is the administration cutting corners in safety and efficacy in its effort to produce vaccines and treatments rapidly? >> not at all, mr. chairman. in fact, the rapidity of where we are right now are the technological advances in vaccine platform technology as well as the risks that were taken financially so that we'll have doses available when the decision is made by the fda as to the safety and efficacy as you've heard from dr. hahn. no cutting corners. >> we're risking the taxpayers' money but not risking safety and efficacy. is that your testimony? >> yes, that's absolutely cor
until fda approves it.illing to take that vaccine for you and for your family? >> absolutely yes, senator. mr. chairman. i have the complete and absolute faith in the expertise of the scientists who are terrific at fda. if they were to make a determination that a vaccine would be safe and effective i would do that and i would encourage my family to take it. >> dr. fauci you've seen lots of diseases, pandemics and responses to it. is the administration cutting corners in safety and...
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Sep 24, 2020
09/20
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the fda, what the fda is expected to do is say to these folks, hey, wait a second.nt you to wait two months past a certain point in the your trial before you can ask us for per in addition to put it on the market. if that ends up happening there is just really no way that we will have a vaccine by election day. the smamath doesn't add up. i heard dr. fauci say there are reasons to support that measure. increases safety. if you spend another two months giving people, giving study subjects the vaccine, you get more data to see, look, it's safe. people aren't reacting badly to it. he put out one kacaveat. if the data is so great, 98% effective vaccine, maybe we don't want to wait the 60 days. i have yet to speak with anyone who thinks that's going to be the case. that we're going to get overwhelmingly excellent efficacy data for a vaccine soon. that just seems highly, highly unli important point to make. the twoaccines front-runners by far in these clinical trials, they both use a technology that is new. it's never been used in a vaccines that on the market in the u.s.
the fda, what the fda is expected to do is say to these folks, hey, wait a second.nt you to wait two months past a certain point in the your trial before you can ask us for per in addition to put it on the market. if that ends up happening there is just really no way that we will have a vaccine by election day. the smamath doesn't add up. i heard dr. fauci say there are reasons to support that measure. increases safety. if you spend another two months giving people, giving study subjects the...
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Sep 24, 2020
09/20
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overrule the fda on this. >> wow. >> d. that is an alarming reality. especially since we know this is one in a series. we had the fda exaggerate convalescent plasma and the president pushing hydroxychloroquine before there was data to indicate that it's helpful for a large portion of the population. i mean, this is a genuine concern here, is it not, given the importance of the vaccine into bringing the outbreak under control? >> one of the things we were hearing so forcefully from the head of the fda is to try to restore faith by the american public that the process for approval will be based burly on science and to provide some transparency on that. so in his remarks and in what fda is talking about, they're talking about following people who got the vaccine a little longer to ensure it's safe and making sure in people who got the placebo, so they didn't get the actual vaccine, that there are enough cases of covid-19 so they can say how truly effective it is, importantly in the elderly. it's important for me as a doctor to
overrule the fda on this. >> wow. >> d. that is an alarming reality. especially since we know this is one in a series. we had the fda exaggerate convalescent plasma and the president pushing hydroxychloroquine before there was data to indicate that it's helpful for a large portion of the population. i mean, this is a genuine concern here, is it not, given the importance of the vaccine into bringing the outbreak under control? >> one of the things we were hearing so forcefully...
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Sep 22, 2020
09/20
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CNNW
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the fda is basically saying not so fast.e want to see if there's significant infections in the placebo group and compare those essentially to not getting infected in the vaccinated group to be confident that the vaccine is actually protecting against serious infections. that could take a while as well, wolf, to actually see those serious infections in the placebo group. put the time line together, and i think you're talking end of the year before you really have that kind of data. >> yeah. dr. wen, the president keeps saying there could be a vaccine before the november 3rd election. previously he railed against what he called the deep state, the deep state over at the fda. how do you expect him to respond to this latest announcement from the fda? >> i don't know how he'll respond. i hope that he doesn't. because the more that the president speaks about a particular date, and especially if he ties it to the elections, every time we see that the percentage of people who say that they're willing to take the vaccine, that it dec
the fda is basically saying not so fast.e want to see if there's significant infections in the placebo group and compare those essentially to not getting infected in the vaccinated group to be confident that the vaccine is actually protecting against serious infections. that could take a while as well, wolf, to actually see those serious infections in the placebo group. put the time line together, and i think you're talking end of the year before you really have that kind of data. >>...
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Sep 25, 2020
09/20
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CNNW
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what does the fda chief say about it?his. >> our experts, who know about vaccines, will make this determination, and it will be only based upon the science and the data, not politics. that's my pledge. >> let's bring in top public-health expert, dr. leana wen. good to see you, doc. >> good to see you, too, chris. >> is the fda right? or can he say speed it up, jack, and he'll say, yes, boss? >> you know, actually, the president and hhs, they do have authority over the fda. so it could be done. it would be unprecedented. but it's possible. then, we have to think about the consequence of what would happen? what if the fda says we're not ready to give emergency-use authorization, but the president says, let's do it, anyway? who is going to take this vaccine? you know, i'm in the group that would be eligible to get this under the emergency-use authorization, as a frontline provider. but i don't know other doctors and nurses who would say, sure, the fda said no, the president said yes, but i'm going to stick out my arm and get
what does the fda chief say about it?his. >> our experts, who know about vaccines, will make this determination, and it will be only based upon the science and the data, not politics. that's my pledge. >> let's bring in top public-health expert, dr. leana wen. good to see you, doc. >> good to see you, too, chris. >> is the fda right? or can he say speed it up, jack, and he'll say, yes, boss? >> you know, actually, the president and hhs, they do have authority over...
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Sep 1, 2020
09/20
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KDTV
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sin embargo, el fda lo alegado.uperior al riesgo. considera que estamos en medio de una emergencia sanitaria. este mÉdico coincide con la fda. >> si hay indicios de que el medicamento es seguro, ademÁs de su efectivo, pueshay una tendencia a autorizar una fase tres, precisamente por la premura de lo que es una pandemia y la cantidad de vidas que se quieren salvar. lourdes: la fda y su director han estado en el ojo del huracÁn antes, por haber tomado decisiones bastante polÉmicas. >> por la hidroxicloroquina que la ha recomendado reciente, hace que los estudio dijeron que no sirve. luego el plasma administrado sin un estudio placebo. lourdes: precisamente, por las crÍticas a la fda y la reciente desconfianza del pÚblico hacia las vacunas, expertos prominentes estÁn pidiendo que se cree una comisiÓn independiente que revise los datos de los ensayos de vacunas, antes de que se permita que una salga al mercado. patricia: vamos a pasar ahora a california, donde la participaciÓn en las clases escolares por internet muestr
sin embargo, el fda lo alegado.uperior al riesgo. considera que estamos en medio de una emergencia sanitaria. este mÉdico coincide con la fda. >> si hay indicios de que el medicamento es seguro, ademÁs de su efectivo, pueshay una tendencia a autorizar una fase tres, precisamente por la premura de lo que es una pandemia y la cantidad de vidas que se quieren salvar. lourdes: la fda y su director han estado en el ojo del huracÁn antes, por haber tomado decisiones bastante polÉmicas....
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Sep 23, 2020
09/20
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CNNW
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and the fda.ld also want to get a better handling on the logistics of administering a vaccine once we're lucky enough to have one approved. what is truly the realistic time frame for distributing this? what kind of venues are we going to use? do we have enough disposables, syringes, have we manufactured enough sterile glass vials for vaccine? what's our cold storage, our cold chain. those details are crucial to get the vaccine out into the public. and there hasn't been a lot of transparency about that. we've just been told, oh, yeah, we'll have a hundred doses of vaccine available. it's meaningless, unless you can get it into arms. and those are some of the details i would like to know from the public health officials >> you're right, john, we should have asked him that. >> you're giving me credit for something that happens off-camera. this is first time. mark this down. alisyn gave me credit. >> i'm giving you credit for something, because it is the first time you deserve it. >> dr. reiner, we're
and the fda.ld also want to get a better handling on the logistics of administering a vaccine once we're lucky enough to have one approved. what is truly the realistic time frame for distributing this? what kind of venues are we going to use? do we have enough disposables, syringes, have we manufactured enough sterile glass vials for vaccine? what's our cold storage, our cold chain. those details are crucial to get the vaccine out into the public. and there hasn't been a lot of transparency...
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Sep 27, 2020
09/20
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CSPAN
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. >> can you talk about how the fda intends to secure that trust of the public?what happens this week? why can trump get involved in approval standards and that process? >> [indiscernible] the leadership of the fda has that we are taking politics out of this process, this decision-making process. that ann immediately fda issue is going all the way up to the white house not for information but for comment and approval. that is politics. that is see that, and why this concern continues both in the public and the profession. under normal circumstances, information after a trial is completed, we would be presented by the manufacturer to the fda, who would then get that information to an external advisory committee that has been long established. they are notoriously rigorous and notoriously independent. --y give advice to the sba, alwaysich several months follow. if the fda take that route, a lot of us will have more confidence in the process. in addition, my advice would be, politicians stand back. let this now be a professional decision, support the professionals a
. >> can you talk about how the fda intends to secure that trust of the public?what happens this week? why can trump get involved in approval standards and that process? >> [indiscernible] the leadership of the fda has that we are taking politics out of this process, this decision-making process. that ann immediately fda issue is going all the way up to the white house not for information but for comment and approval. that is politics. that is see that, and why this concern...
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Sep 4, 2020
09/20
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CNNW
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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 live claritin clear. >>> joe biden traveled to wisconsin today. unlike the
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...
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Sep 9, 2020
09/20
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CSPAN
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we have been transparent at fda. we have put out guidance on what the fda is looking for in terms of faxing approval. we have made it clear there will be a process with the fda. i welcome the statement and i think it may help with a lot of those who are spreading these terrible anti-public health, anti-vaccine messages. we have got to ensure public confidence in our systems and our processes just like our influenza season. we need to get people vaccinated. if we do get an fda gold standard vaccine are vaccines, need to make sure people are willing to take them once they are available. hard to see is outside of the pandemic at this point, but outside the pandemic, what are your priorities for hhs at this moment? wewe continue -- sec. azar: continue to drive and all the things we have been working on before. we are working on health system transformation. we are still driving towards that transparency of pricing and quality of information and from insurance companies. we have implemented the health and information tech
we have been transparent at fda. we have put out guidance on what the fda is looking for in terms of faxing approval. we have made it clear there will be a process with the fda. i welcome the statement and i think it may help with a lot of those who are spreading these terrible anti-public health, anti-vaccine messages. we have got to ensure public confidence in our systems and our processes just like our influenza season. we need to get people vaccinated. if we do get an fda gold standard...
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Sep 12, 2020
09/20
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CSPAN
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the safety datalink by the fda that can look for rare adverse effects. as ruth said, you know the vaccine is effective for a certain length of time. you have to be really honest and transparent about what you know and what you do not know. if we do that, it is going to be a slow climb up the hill, but i think we can get there. >> mike, are we going to have an annual coronavirus vaccine? do i need to prepare my children for flue shots and coronavirus shots? >> i do not know that. there has been monitoring of the , what emerged in china, and that would be one of the things to watch. thisul mentioned earlier is a novel virus. coronavirus that does not strikingh seasonality. commentadd, if i may, a to the last discussion and that nts to bell of our te open, two points. there is a part of the population who said they will not take the vaccine. there are some divided into one group that is fanatically, conceptually anti-vaccine. their mindsot be -- will not be changed based on interactions of the measles vaccination in past years. the other two are hesitant. t
the safety datalink by the fda that can look for rare adverse effects. as ruth said, you know the vaccine is effective for a certain length of time. you have to be really honest and transparent about what you know and what you do not know. if we do that, it is going to be a slow climb up the hill, but i think we can get there. >> mike, are we going to have an annual coronavirus vaccine? do i need to prepare my children for flue shots and coronavirus shots? >> i do not know that....
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Sep 9, 2020
09/20
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CSPAN
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that's what the fda does. it stands between the american public and the pharmaceutical industry to make sure that you get a product that is safety. it worries me that they felt the need to do that. what they are doing when they write that letter, they are saying to this country that there is a question about the fda's willingness to stand up to the administration that is going to be under pressure. the pressure is going to come not just from the november 3 election, but the fact that china, russia and the u.k. may well come out with a vaccine before we do. the fdaands, between vaccine advisory committee, and dr. hahn and his commitment on paper to make sure we hold these to a standard, i feel good. but you are a little worried. that is it. maybe i am a warrio worrier. it does worry me a little bit. i will stop there. thank you. >> just to follow-up on a couple of points, and i will bring others into the conversation as well, is there a guarantee that we will have a covid-19 vaccine, because as many scientists
that's what the fda does. it stands between the american public and the pharmaceutical industry to make sure that you get a product that is safety. it worries me that they felt the need to do that. what they are doing when they write that letter, they are saying to this country that there is a question about the fda's willingness to stand up to the administration that is going to be under pressure. the pressure is going to come not just from the november 3 election, but the fact that china,...
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Sep 10, 2020
09/20
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that the fda, for those with confidence, they need to be able to trust the toentific experts at the fdandependently and make those decisions based on the science. that's important and any pressure on the fda from outside needs to stop if people want to trust the vaccines. i am very sympathetic to getting it quickly, everybody wants that . but as polling has shown, the ableity people want to be to have that process be done in that ensures that vaccines are is this -- as safed and effective -- as safe and effective as could be. if we want to vaccine, which we all want to help and the pandemic, people need to be able .o trust the recommendations the fda has said it will stick to the science. when there's pressure people become skeptical. this is important to address in the upcoming month. the fda need to be really transparent about the data it and it any approvals and aergency authorizations to public advisory committee. that will help. but i think some damage has been done to the public trust. host: once a vaccine is available, will it be cost prohibitive for some people? i think that's a
that the fda, for those with confidence, they need to be able to trust the toentific experts at the fdandependently and make those decisions based on the science. that's important and any pressure on the fda from outside needs to stop if people want to trust the vaccines. i am very sympathetic to getting it quickly, everybody wants that . but as polling has shown, the ableity people want to be to have that process be done in that ensures that vaccines are is this -- as safed and effective -- as...
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Sep 23, 2020
09/20
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CNNW
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so can the fda do this without him signing off? >> so i think there are maybe a couple of different things going on here. i do think that the fda can enforce this and they do so by telling the companies what they expect and any company would be foolhardy to submit something with what the fda said they required. i think they'll go along with this. the second relates to the memo from secretary azar, which i do think is, you know, something of a power grab by him. but what it does is it relates to new regulations and these orders that relate to vaccine approval and emergency use authorization they aren't orders. the move by the secretary to insist he signs all regulations i don't think it affects all regulatory approval. >> so your comment about it being a power grab, the chief of staff to him, harrison, said this is a housekeeping matter. it has no bearing on how the agency deals with covid vaccines. explain why you think the hhs secretary shouldn't have this power. >> well, you know, what this really relates to is whether or not giv
so can the fda do this without him signing off? >> so i think there are maybe a couple of different things going on here. i do think that the fda can enforce this and they do so by telling the companies what they expect and any company would be foolhardy to submit something with what the fda said they required. i think they'll go along with this. the second relates to the memo from secretary azar, which i do think is, you know, something of a power grab by him. but what it does is it...
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Sep 11, 2020
09/20
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and the fda -- you know, the head of the fda misstating the efficacy of it.ving to kind of walk it back and apologize. >> well, i think i can provide some reassurance about all the steps that are involved in this kind of decision-making. first of all, there is something called the dsmb, the data and safety monitoring board. that watches over these vaccine trials. they are the only people, and they're not political appointees. they are scientists looking at the data. they're the only ones watching to see who got the vaccine and who got the placebo, and what happened? nobody else knows. nobody else is unblinded. just that group. they aren't going to raise their hand and say, hey, it's time to look at this, fda, unless they see strong, statistically convincing data, that this vaccine is working and it's safe. >> they might raise their hand and say it's not working. give it up. they might raise their hand and say there's a problem here. like there was yesterday, with the astrazeneca trial, which needed to be put on clinical hold. but they are -- they're -- they'r
and the fda -- you know, the head of the fda misstating the efficacy of it.ving to kind of walk it back and apologize. >> well, i think i can provide some reassurance about all the steps that are involved in this kind of decision-making. first of all, there is something called the dsmb, the data and safety monitoring board. that watches over these vaccine trials. they are the only people, and they're not political appointees. they are scientists looking at the data. they're the only ones...
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Sep 10, 2020
09/20
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CSPAN2
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this is buy the book, we've been very transparent with fda and put our guidance with the fda looking for in terms of vaccine approval, we made it clear there will be a transparent advisory committee process with fda and i welcome the statement in i think it may help with a lot of those spreading the terrible anti-public health, anti-vax messages. we've got ensure public confidence in our system in just a influenza season and we needed people vaccinated in a standard vaccine and we need to make sure people are willing to take them once they arere available. >> i know it's hard to see outside the pandemic at this point but outside the pandemic, what are your priorities for hhs at this moment in time. >> we continue to drive on all the things that we've been working on before. but were working on health and transformation, were still driving towards a transparency of price and quality and information hospital and insurance companies. we have implemented the health information technology interoperability platforms, we continue to work on the most intractable disease states like sickle-ce
this is buy the book, we've been very transparent with fda and put our guidance with the fda looking for in terms of vaccine approval, we made it clear there will be a transparent advisory committee process with fda and i welcome the statement in i think it may help with a lot of those spreading the terrible anti-public health, anti-vax messages. we've got ensure public confidence in our system in just a influenza season and we needed people vaccinated in a standard vaccine and we need to make...
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Sep 4, 2020
09/20
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CNNW
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right now it is the fda and this vaccine. and that means the fda commissioner is now in the hot seat because there are a lot of questions about the approval process for a vaccine and whether or not they would grant some kind of emergency use authorization like we've seen them do with hydroxychloroquine, something that the president pushed for and can val essent plasma. with hydroxychloroquine it had to be rescinded by the fda later on, plasma is still out. though we did see the commissioner apologize for how he framed that announcement and now the question comes down to whether or not we could see one with a vaccine. it is very clear that the president wants one and he is accused people at the fda of deliberately delaying progress because they -- in the president's mind they think he wants to hurt his chances of being re-elected. and look at how he's explaining what you wants this time line to look like. >> i think the vac vcines are going to be announced very soon and you're going to see great companies announcing. i spoke w
right now it is the fda and this vaccine. and that means the fda commissioner is now in the hot seat because there are a lot of questions about the approval process for a vaccine and whether or not they would grant some kind of emergency use authorization like we've seen them do with hydroxychloroquine, something that the president pushed for and can val essent plasma. with hydroxychloroquine it had to be rescinded by the fda later on, plasma is still out. though we did see the commissioner...
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Sep 10, 2020
09/20
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vaccines are approved by the fda.hey can either license a vaccine or authorize it for use doing a public health emergency and the fda's stringent approval process is the world's gold standard. the vaccines are routinely -- that are given to children are recommended by the advisory committee on immunization practices, an outside group of health experts that look at all available scientific information about each vaccine. and then medical associations like the american academy of pediatrics, the american academy of physicians work with that agency to develop these recommendations. in a 2015 article in the scientific america, it is written that by age two most children will receive almost 30 shots designed to boost a child's natural defenses against disease yet at the same time, parents who take their child for those recommended vaccinations might be inundated with website rumorsebrity espoused making false claims that shots are not necessary or cause autism. she continues, "at best navigating this landscape can be confu
vaccines are approved by the fda.hey can either license a vaccine or authorize it for use doing a public health emergency and the fda's stringent approval process is the world's gold standard. the vaccines are routinely -- that are given to children are recommended by the advisory committee on immunization practices, an outside group of health experts that look at all available scientific information about each vaccine. and then medical associations like the american academy of pediatrics, the...
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Sep 23, 2020
09/20
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CNNW
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that's what the fda zeroed in on. two months is a reasonable amount of ticme to wait to see f people are developing side effects. this is not surprising to me when i spoke to moncef louis. >> if you look into the databases of the fda, the overwhelming adverse events happen within the first 42 days after completing the immunization regimen and maybe fwhons after completing -- it doesn't mean things may not happen way after, it could. extremely rare. >> they went back into the fda and they said, let's look at previous vaccines. when do the majority of side effects occur if heir going to occur at all, and 42 days to two months. that's the time frame. they're applying that now when they go back and look at these vaccine protocols. they're applying that as a way to measure safety. >> tell us about what johnson & johnson is announcing. they have the fourth vaccine in the u.s. to enter phase iii trials, but theirs is different. >> yeah, so -- and i spoke to the head of the vaccine project, you know, in amsterdam some time ag
that's what the fda zeroed in on. two months is a reasonable amount of ticme to wait to see f people are developing side effects. this is not surprising to me when i spoke to moncef louis. >> if you look into the databases of the fda, the overwhelming adverse events happen within the first 42 days after completing the immunization regimen and maybe fwhons after completing -- it doesn't mean things may not happen way after, it could. extremely rare. >> they went back into the fda and...
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Sep 24, 2020
09/20
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KDTV
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trump hizo esta advertencia, luego de que funcionarios de la fda testificaron ante el senado diciendolo estarÁ disponible cuando sea segura y sin presiÓn polÍtica. declarÓ asÍ el director de la fda bajo juramento en el senado. >> no aprobaremos una vacuna que no quisiÉramos dar a nuestras familias. janet: explicÓ que la fda tendrÁ un mÉtodo riguroso con un panel de cientÍficos que evaluarÁn las vacunas sometidas a aprobaciÓn. la agencia ha estado bajo presiÓn del presidente trumppara que apruebe una vacuna lo mÁs pronto posible, idealmente antes de las elecciones del 3 de noviembre. en la audiencia, usan a republicano atacÓ las declaraciones del doctor fauci. dijo que new york no hay pandemia. [habla en inglÉs] de hecho, el director de los cdc... [habla en inglÉs] dijo que la mayorÍa de los estadounidenses aÚn no se han contagiado, y que son vulnerables a padecer y a morir del coronavirus. que no serÍa sino hasta el prÓximo verano cuando todo el paÍs pueda ser vacunado. entre tanto, una nueva vacuna candidata entro en la tercera fase del estudio. a diferencia de las otras vacunas bajo
trump hizo esta advertencia, luego de que funcionarios de la fda testificaron ante el senado diciendolo estarÁ disponible cuando sea segura y sin presiÓn polÍtica. declarÓ asÍ el director de la fda bajo juramento en el senado. >> no aprobaremos una vacuna que no quisiÉramos dar a nuestras familias. janet: explicÓ que la fda tendrÁ un mÉtodo riguroso con un panel de cientÍficos que evaluarÁn las vacunas sometidas a aprobaciÓn. la agencia ha estado bajo presiÓn del presidente...
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Sep 25, 2020
09/20
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CNNW
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but irsaying you don't trust an fda review, that you think it's so politicized you can't trust the fdathey say there's a covid vaccine, governor? >> the fda said they want to bring in outside observers as part of the process to provide comfort to the american people. trump said he didn't think that was necessary, as if he's an expert on science and public health, and that he might overrule the fda. so, the american people don't trust the process. i don't trust the process. this is a president who you know calls health officials and tells them what he wants done politically. so, i think it would actually serve the public if they knew there was a bona fide review because you don't want to come out with a vaccine that people are afraid to take. >> 100%. the companies have come out in the unprecedented way and said that they are not going to put anything out that isn't safe. i understand the points you're making, governor. but are you worried you are actually adding to people's unwillingness to take a vaccine and to vaccine fears by saying what you're saying? you just said, quote, i don't
but irsaying you don't trust an fda review, that you think it's so politicized you can't trust the fdathey say there's a covid vaccine, governor? >> the fda said they want to bring in outside observers as part of the process to provide comfort to the american people. trump said he didn't think that was necessary, as if he's an expert on science and public health, and that he might overrule the fda. so, the american people don't trust the process. i don't trust the process. this is a...
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Sep 1, 2020
09/20
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KDTV
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el jefe de la fda lo alegado.ndo que estamos en medio de un emergencia sanitaria. este mÉdico coincide con la visiÓn de la fda. >> si hay indicios de que el medicamento es seguro y efectivo, hay una tendencia a autorizar este tipo de medicamentos donde no hay una fase tres de ningÚn estudio, precisamente por la premura de lo que es una pandemia y la cantidad de vidas que se busca salvar. lourdes: la fda y su director han estado en el ojo del huracÁn antes por haber tomado decisiones polÉmicas. >> con la hidroxicloroquina, recomendable reciente, hasta que mostraron que no sirve. el plasma, suministrado sin un estudio placebo. lourdes: precisamente por las crÍticas a la fda y la creciente desconfianza del pÚblico hacia las vacunas que reflejan las encuestas, expertos pide que se cree una comisiÓn independiente que revise los datos de los ensayos de vacunas, antes de que se permita de que una salga al mercado. los cdc han sido criticados por el cambio sus recomendaciones. aseguraron de que no se deben hacer la prueba
el jefe de la fda lo alegado.ndo que estamos en medio de un emergencia sanitaria. este mÉdico coincide con la visiÓn de la fda. >> si hay indicios de que el medicamento es seguro y efectivo, hay una tendencia a autorizar este tipo de medicamentos donde no hay una fase tres de ningÚn estudio, precisamente por la premura de lo que es una pandemia y la cantidad de vidas que se busca salvar. lourdes: la fda y su director han estado en el ojo del huracÁn antes por haber tomado decisiones...
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Sep 16, 2020
09/20
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MSNBCW
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fda to produce a vaccine, how do you see it from your perspective, are we seeing the fda and cdc feeling that pressure >> clearly you're seeing today with the cdc director testifying, trying to say, listen, there hasn't been any implications of politics, puttingany pressure on what's going happen with the fda, what's going to happen with a vaccine, clearly the medical community is trying to stave off any concerns about that. i do think when you have the president and others in his administration forcefully trying to make this happen as fast as possible, clearly even the white house chief of staff mark meadows was saying, a vaccine available as close as three weeks from now is a very different place than where the medical community is, the white house is under pressure here, to the extent the president was tweeting about coronavirus relief because they're looking at an election that'sless than 50 days away and it doesn't appear that a vaccine is going to be coming any time before the election. >> and to that point, jonathan, the president claimed in a town hall last night that he, quote,
fda to produce a vaccine, how do you see it from your perspective, are we seeing the fda and cdc feeling that pressure >> clearly you're seeing today with the cdc director testifying, trying to say, listen, there hasn't been any implications of politics, puttingany pressure on what's going happen with the fda, what's going to happen with a vaccine, clearly the medical community is trying to stave off any concerns about that. i do think when you have the president and others in his...
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Sep 8, 2020
09/20
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FOXNEWSW
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former fda commissioners like me have all been saying the same thing.ss in place that they tend to apply here to make sure the vaccine that are approved for users are safe and effective. that's really important so that americans can have confidence to use the vaccines and get us out of the pandemic. >> charles: the fda process has been criticized by many for a long time. it takes a long time and you can spend billions of dollars with phase one, phase two, phase three, and then you only get to sell a drug before they rip you off with the generic version. with this operation warp speed, the process -- how taking the integrity of the process? >> i wouldn't say it's truncating the process. when people hear words like operation warp speed they think it's something going too fast for safety, but what has happened with the vaccine process is that several things that usually happen one after the other are happening at the same time. thanks in part because the fda has laid out clear expectations that they want to see a vaccine shown to significantly reduce covid
former fda commissioners like me have all been saying the same thing.ss in place that they tend to apply here to make sure the vaccine that are approved for users are safe and effective. that's really important so that americans can have confidence to use the vaccines and get us out of the pandemic. >> charles: the fda process has been criticized by many for a long time. it takes a long time and you can spend billions of dollars with phase one, phase two, phase three, and then you only...
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Sep 25, 2020
09/20
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do you feel that the fda will be pressured?fda could be pressured, just like cdc has been. but i think we, as citizens, and myself as an investigator, we have to trust the process. and we need to be sure that, you know, the process of approving a vaccine, the clinical trials process, the way a data safety monitor board is established for every study, the way the data is looked at, the way that it goes to the fda, the increase of the fda career scientists, when they look at the data, if we let the process take place the way it should, there shouldn't be a problem. the president doesn't have the ability to do that. it is really the career scientists at the fda who know what they're looking at and we'll have to make the determination. so we have to trust the process. >> yeah. dr. carlos del us -- where we ar country right now. great to see you. >>> all right. requests for mail-in ballots already breaking records. the brand-new numbers for you, next. ♪ it's grilled cheese time. ♪ yeah, it's time for grilled cheese. ♪ ♪ after we mak
do you feel that the fda will be pressured?fda could be pressured, just like cdc has been. but i think we, as citizens, and myself as an investigator, we have to trust the process. and we need to be sure that, you know, the process of approving a vaccine, the clinical trials process, the way a data safety monitor board is established for every study, the way the data is looked at, the way that it goes to the fda, the increase of the fda career scientists, when they look at the data, if we let...
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Sep 11, 2020
09/20
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then, of course, it goes to the fda.y process, this vaccine and related projects advisory committee that will be very engaged in advising the fda about issuing or not an emergency use authorization. and we have the ceost whose said they're not going to go to the fda unless they believe the data. they don't want their reputations to be besmirched either. there are a lot of protective steps here that will keep this from running off the rails. >> there is some guidance the fda provides ahead of time. they said for manufactures working on the vaccine, they're asking for 50% efficacy, that it works 50%. that's not normally done, is it? i was trying to look back through the type of guidance that fda provides. first of all, is this common and 50%, does that seem like enough? >> there's a lot of discussion about that. i think, again, ideally you want a vaccine that's 100% effective, and we hope one of these might turn out to be that. but if you had a vaccine 50% effective and that's all you had for the next year, you would still
then, of course, it goes to the fda.y process, this vaccine and related projects advisory committee that will be very engaged in advising the fda about issuing or not an emergency use authorization. and we have the ceost whose said they're not going to go to the fda unless they believe the data. they don't want their reputations to be besmirched either. there are a lot of protective steps here that will keep this from running off the rails. >> there is some guidance the fda provides ahead...
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Sep 24, 2020
09/20
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KNTV
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fda is going to call these balls and strikes according to clear standards that fda has that is out thereplaying this astrazeneca, one of the four manufacturers in phase three, the final stage of clinical trials, they had a single adverse event in the united kingdom. as a result, trials were stopped worldwide. the united kingdom restarted, brazil restarted here in the united states, the fda is holding back on restarting that trial because they're going to make sure that they believe there's no association between the vaccine and any adverse events there's no political interference the fda is going to call those balls and strikes at the career level there, and the american people should be reassured we stand for patient safety. everything is going to be by science, data, and rule of law. let me >> you are passionate in that statement. i have to play you something that the president said not long ago, where he directly tied the timing of the vaccine to election day let me play it >> so we're going to have a vaccine very soon, maybe even before a very special date you know what date i'm talk
fda is going to call these balls and strikes according to clear standards that fda has that is out thereplaying this astrazeneca, one of the four manufacturers in phase three, the final stage of clinical trials, they had a single adverse event in the united kingdom. as a result, trials were stopped worldwide. the united kingdom restarted, brazil restarted here in the united states, the fda is holding back on restarting that trial because they're going to make sure that they believe there's no...