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Jan 8, 2021
01/21
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i am confident that fda will ten along this path. continue actually growing and learning on behalf of the mission to protect the health and safety of the american public and i just want to end by my absolute thanks to the 17, 18,000 plus americans who have been dedicated throughout this pandemic and to whom we owe much. thank you very much for this and i'm very happy to answer questions. >> thank you, very, very much. and we have several people who are now lined up. let me ask is christine layman, are you available? let me remind everyone to signal if you have a question, you press the reaction button and then the hand raise button at the bottom of your zoom window and you'll then be placed in the queue. christine layman, are you in the queue? not hearing that. >> yes, i-- my questions. >> would you like to ask it or do you want me to? >> go ahead. >> christine is asking, what will happen to the vaccines authoriz authorized under the eau's expired. don't they still have to go through an approval process and what will be reviewed then
i am confident that fda will ten along this path. continue actually growing and learning on behalf of the mission to protect the health and safety of the american public and i just want to end by my absolute thanks to the 17, 18,000 plus americans who have been dedicated throughout this pandemic and to whom we owe much. thank you very much for this and i'm very happy to answer questions. >> thank you, very, very much. and we have several people who are now lined up. let me ask is...
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Jan 9, 2021
01/21
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CSPAN2
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and families have faced turmoil and tragedy and we see the extraordinary encourage and resolve, the fda has been at the center of the government's efforts with the public up emergency and it is staged professional personal challenges. we have worked hard to meet these challenges with unprecedented scientific effort and diligence. the agency workload increased significantly to methinks ordinary demand of covid-19 on the order of approximately doubling our normal work in our workforce responded in kind taking on the new challenges walk continuing to fulfill our regular mission critical responsibility, i would like to address aspects of this commitment and i'll start by giving you a small sampling of our non-covid related achievements from the past year, our foods team worked diligently to address food supplies during the crisis and to support employers inc. covid industries to resume safely and we all know food security is national security and the significant component to that, at the same time the career staff also advanced initiatives related to food safety generally in july we announc
and families have faced turmoil and tragedy and we see the extraordinary encourage and resolve, the fda has been at the center of the government's efforts with the public up emergency and it is staged professional personal challenges. we have worked hard to meet these challenges with unprecedented scientific effort and diligence. the agency workload increased significantly to methinks ordinary demand of covid-19 on the order of approximately doubling our normal work in our workforce responded...
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Jan 13, 2021
01/21
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why the fda goes line by line. we aren't just going to rely the number provided to us by sponsor in what we want to do is look at the data from one large randomized trial and we are going to look at those data into our own number crunching and make sure we are confident that whatever numbers is boris efficacy and safety comes of the trail we are confident that the data represent separate in general that's what it v-8 does and we will absolutely stick with that during my tenure and after that i have confidence the agency will do so. >> one last quick question from matthew. >> dr. de leon six thank you for taking questions. for many months you've emphasized the importance of datata in science and fda decisions and it's clear you've worked veryy i hard to make sure that's the case but over the years there have been proposals for ways to insulate the fda from those political forces making a a separate agency outse of hhs into a fixed term. as you near the end of your tenure and reflecting on your time on the job do you
why the fda goes line by line. we aren't just going to rely the number provided to us by sponsor in what we want to do is look at the data from one large randomized trial and we are going to look at those data into our own number crunching and make sure we are confident that whatever numbers is boris efficacy and safety comes of the trail we are confident that the data represent separate in general that's what it v-8 does and we will absolutely stick with that during my tenure and after that i...
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Jan 9, 2021
01/21
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KRON
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is saying you can go to their website which is fda dot gov.ut for now in the north bay charles clifford kron 4 news. >>but we have made it to friday. the press everybody it is been a week now it's time for a check on the forecast quite a week 4 chief meteorologist lawrence karnow is going to join us now with a look at the weekend forecast, yes seems like 2 weeks and one doesn't it's been a long one up there that's for sure but tonight we are looking at your skies and beautiful sunset around the bay area we've got some high clouds drifting up above an there you go the sun setting on what looks proving whether as far warmer temperatures are concerned here rain amounts from the storm system 2100's. >>in santa rosa storm moved through last night 700 stare him or in that but check in 400 san francisco 407 inch of rain a little more than a drop in bucket there in oakland woodside checking in with 400 so just a weak little system sliding on by seeing scootin eastward there behind that high pressure sneaking in today and that slaughter skies to clear
is saying you can go to their website which is fda dot gov.ut for now in the north bay charles clifford kron 4 news. >>but we have made it to friday. the press everybody it is been a week now it's time for a check on the forecast quite a week 4 chief meteorologist lawrence karnow is going to join us now with a look at the weekend forecast, yes seems like 2 weeks and one doesn't it's been a long one up there that's for sure but tonight we are looking at your skies and beautiful sunset...
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Jan 8, 2021
01/21
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or fda does not endorse prohibit the use of any product like that. they use the data in the science to guide those decisions. i would recommend that they look at the data and science behind that. there are paths moving forward. provided guidance. we absolutely must issue the safety warnings. there are ways with repeat testing and confirmation testing that can be employed. to get around some of the issues we are seeing. we will continue to issue the safety warning. we think it is very important that any end user of the test look at the data in the science. we are very willing to help with that. g update a you are able to share today? to then: i will go back center and see what we can release that is not confidential commercial information. >> thank you. >> thank you very much. >> thank you for speaking with me today. question is pretty general. the commissioner through a tumble to us time for the country. the white house has attacked you at times. are there things you wish you had done differently. dr. hahn: thank you. this has been an unprecedented t
or fda does not endorse prohibit the use of any product like that. they use the data in the science to guide those decisions. i would recommend that they look at the data and science behind that. there are paths moving forward. provided guidance. we absolutely must issue the safety warnings. there are ways with repeat testing and confirmation testing that can be employed. to get around some of the issues we are seeing. we will continue to issue the safety warning. we think it is very important...
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Jan 9, 2021
01/21
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KRON
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is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>pfizer says a preliminary study indicates that its vaccine works against the coronavirus variance that are spreading in the uk and south africa, the variant which is also been detected here in california has a slight alteration of the spike protein that coats the virus. vaccines train the body to recognize that protein and then go out and fight it antibodies in the blood of 20 people given the pfizer shot successfully fought off the virus in lab dishes. the study was small and it hasn't been reviewed by other medical experts which is of course the key step in research. president elect joe biden plans to release nearly all available doses of the covid-19 vaccine after taking office. a biden spokesperson says that the trump administration has been holding back half of the available doses to ensure that there's enough supply for everyone who is getting a first dose to later get that second dose as well but the biden transition
is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>pfizer says a preliminary study indicates that its vaccine works against the coronavirus variance that are spreading in the uk and south africa, the variant which is also been detected here in california has a slight alteration of the spike protein that coats the virus. vaccines train the body to recognize that protein and then go out and fight it antibodies in the...
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>> well, aim glad the fda fda fa came out on this, mona, because we don't have the data to back any evidence that have half of the dose will be effective, and if we have partial immunity or we don't really have the full dose that we know works, we risk the vaccine not being effective at all, and we are back at square one. >> dr. ali, new york's governor is threatening to fine hospitals who move too slow in vaccinating people. do you think that would be effective? >> not really, mona, because i think right now we have 50 million doses distributed. only 4.5 million as of yesterday morning were actually given to patients. with this kind of vaccine, the mrna vaccine, you have to dilute it, you have to thaw it. you need staff who are trained and health departments are understaffed and underfunded, so we actually need help, and i think just, you know, criticizing departments are not going to help. we need to get funding and we need to get staffing. >> the new variant of the virus is now in new york and at least three other states. we've heard this variant is more contagious yet not more deadly, ho
>> well, aim glad the fda fda fa came out on this, mona, because we don't have the data to back any evidence that have half of the dose will be effective, and if we have partial immunity or we don't really have the full dose that we know works, we risk the vaccine not being effective at all, and we are back at square one. >> dr. ali, new york's governor is threatening to fine hospitals who move too slow in vaccinating people. do you think that would be effective? >> not...
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Jan 15, 2021
01/21
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the only one we have seen so far as far as on the fda label that came through this fda review process came around some of these cases of severe allergic reactions. the speaker pro tempore: the house will be in order. the chair lays before the house a communication from the speaker. the clerk: the speaker's rooms, washington, d.c. january 15, 2021. i hereby appoint the honorable terry a. sewell to act as speaker pro tempore on this day. signed, nancy pelosi, speaker of the house of representatives. the speaker pro tempore: the prayer will be offered by chaplain kibben. chaplain kibben: would you pray with me. everlasting god, hear our prayers as we make our requests spoken and unspoken to you. relieve us from any anxiety that prevents us from believing in and living into your gracious plan for these days. remind us to not look not to our own interests but to the good of this country and its people as we move forward. reveal to us that which is true, honorable, just, and pure and may we, in all that we say and do, be guided by these things in serving your people. this is the day that yo
the only one we have seen so far as far as on the fda label that came through this fda review process came around some of these cases of severe allergic reactions. the speaker pro tempore: the house will be in order. the chair lays before the house a communication from the speaker. the clerk: the speaker's rooms, washington, d.c. january 15, 2021. i hereby appoint the honorable terry a. sewell to act as speaker pro tempore on this day. signed, nancy pelosi, speaker of the house of...
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Jan 27, 2021
01/21
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KDTV
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ante esto la fda ha emitido otra alerta para mÁs del 80% de sus productos.salud. sin duda los gel de manos se han convertido en artÍculos de primera necesidad. ¿quÉ deben saber entonces los consumidores sobre esta alerta? ¿cÓmo podemos identificar estos productos daÑinos? gloria: exactamente, la fda emitiÓ una alerta, lo que quiere decir es que todos los desinfectantes que vengan de mÉxico pueden ser detenidos en la frontera. y pueden ser sujetos a inspecciÓn. es importante que las personas que tengan desinfectantes a base de alcohol en sus casas, chequen nuestra lista para ver si estÁ. si por alguna razÓn no aparece el fabricante pueden contactar al distribuidor que tambiÉn debe tener la etiqueta y preguntarle de dÓnde viene este desinfectante de manos. carolina: gloria, en casa seguramente todos tenemos varias botellitas de este desinfectante. ¿quÉ pasa si nosotros o nuestros hijos por accidente toca uno de estos desinfectantes? ¿debe contactarse directamente con el mÉdico o esperar algÚn tipo de reacciÓn? gloria: bueno, estos desinfectantes de manos, dice
ante esto la fda ha emitido otra alerta para mÁs del 80% de sus productos.salud. sin duda los gel de manos se han convertido en artÍculos de primera necesidad. ¿quÉ deben saber entonces los consumidores sobre esta alerta? ¿cÓmo podemos identificar estos productos daÑinos? gloria: exactamente, la fda emitiÓ una alerta, lo que quiere decir es que todos los desinfectantes que vengan de mÉxico pueden ser detenidos en la frontera. y pueden ser sujetos a inspecciÓn. es importante que las...
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Jan 9, 2021
01/21
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KRON
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is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>coming up next the good news from a bay area county hit hard by coronavirus we're going to take a look at the vaccine rollout for health care workers in santa clara county. also the governor he's not presenting a much rosier picture for california's budget and after the break disturbing new video from inside the capitol as rioters were forcing their >>welcome back to the news at 8 o'clock our top story tonight, the search is intensifying tonight for the people behind the death of a capitol police officer during the violent siege on wednesday, and this comes as we are seeing disturbing new video from inside the capital as rioters were forcing their way inside reporter brian entin brings us the story from washington d c. >>new disturbing video shows the car rioters punching try to remove police officers, gas masks. the enormous group pushes to get inside. that's when you see a police officer get crushed in the doorway. there's
is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>coming up next the good news from a bay area county hit hard by coronavirus we're going to take a look at the vaccine rollout for health care workers in santa clara county. also the governor he's not presenting a much rosier picture for california's budget and after the break disturbing new video from inside the capitol as rioters were forcing their >>welcome back...
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Jan 5, 2021
01/21
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tonight the fda said the fda authorized dosing or scheduling of these vaccines is premature and not rootede evidence without appropriate data supporting it. we run a significant risk of placing public health at risk. getting vaccines into arms a major problem right now. today the cdc said just over 15 million doses have been distributed. only 4.5 million administered to patients. that's only about 337,000 more than on saturday. the virus took a life every 33 seconds. today another new hospitalization high. more than 128,000. despite all that, the head of the effort told cnn this morning nothing that has gone wrong. and tried to deny the promise of 28 million vaccinated by the end of the year. >> nothing has gone wrong. what we committed to is to have 20,000 doses available for the american people to be immunized with. >> no. it was that 20 million americans would be vaccinated. here is the sound of the promise that was made. listen to this. >> we will deliver 100 million doses of a safe vaccine before the end of the year. it may be quite a bit sooner than that. >> we expect to have approxi
tonight the fda said the fda authorized dosing or scheduling of these vaccines is premature and not rootede evidence without appropriate data supporting it. we run a significant risk of placing public health at risk. getting vaccines into arms a major problem right now. today the cdc said just over 15 million doses have been distributed. only 4.5 million administered to patients. that's only about 337,000 more than on saturday. the virus took a life every 33 seconds. today another new...
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Jan 16, 2021
01/21
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the fda recommended timeframe. we will always be honest and transparent about where we stand with both the good news as well as the bad. we are going to make sure that state and local officials know so they can plan. right now we hear that they cannot plan if they do not know how much vaccine -- that stops when we are in office. we also promise to provide regular updates to you, the american people. we will be transparent about the decisions we are making and why we are making the decisions. you are entitled to know and our administration will lead to a scientist with the center of disease control and the national institute of health that will be totally free from clinical influence. a surgeon general who is independent and speaks directly to the american people. an fda millions of americans already got in vaccine and millions more are ready to get it. we also know that we need to address vaccine hesitancy and build trust in many communities. we know that that is the case in black/latino/native american communities
the fda recommended timeframe. we will always be honest and transparent about where we stand with both the good news as well as the bad. we are going to make sure that state and local officials know so they can plan. right now we hear that they cannot plan if they do not know how much vaccine -- that stops when we are in office. we also promise to provide regular updates to you, the american people. we will be transparent about the decisions we are making and why we are making the decisions....
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Jan 29, 2021
01/21
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>> we will knock it ahead of the fda. -- we will not get ahead of the fda. if there are additional vaccines, if and when, i will be optimistic, that are approved by the fda, and how that will impact our vaccine distribution plan. >> on the coronavirus relief bill, his first office and month, obama traveled to a number of key states to drum up support for the recovery act. does president biden have any plans to do something similar to drum up support for his $1.9 trillion coronavirus bill? >> then vice president biden also traveled to a number of states to drum up support for the american recovery act in a time. we were not dealing with a pandemic, so the circumstances were quite different. he fully recognizes, as do we, the importance of speaking directly to the american people about the components of the package, importance of the funding to get schools open or vaccines the arms of americans or to get food on the table. to take a number of creative steps to do that, whether that is direct television or local media or from the president and vice president an
>> we will knock it ahead of the fda. -- we will not get ahead of the fda. if there are additional vaccines, if and when, i will be optimistic, that are approved by the fda, and how that will impact our vaccine distribution plan. >> on the coronavirus relief bill, his first office and month, obama traveled to a number of key states to drum up support for the recovery act. does president biden have any plans to do something similar to drum up support for his $1.9 trillion coronavirus...
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Jan 29, 2021
01/21
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CNNW
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we don't have a time line for when that will happen and we leave that to the fda. go ahead. >> thank you. a couple of questions on the economy. starting with china. president trump signed a phase one trade deal with beijing. does president biden consider that deal still to be in effect and does he expect china to meet its commitments under that deal? >> well, the national security team, the newly confirmed secretary of state to president biden are all reviewing all aspects of our national security approach, including certainly our relationship with china. we are focused on approaching that relationship from a position of strength and that means coordinating and communicate with our allies and partners about how we're going to work with china and it means strengthening our economy at home and that means determining the best path forward to address a range of issues. not just economic but strategic and also security. so, again, everything is under review. but i don't have anything for you on the more -- more on the china relationship. >> to clarify. so it is still in
we don't have a time line for when that will happen and we leave that to the fda. go ahead. >> thank you. a couple of questions on the economy. starting with china. president trump signed a phase one trade deal with beijing. does president biden consider that deal still to be in effect and does he expect china to meet its commitments under that deal? >> well, the national security team, the newly confirmed secretary of state to president biden are all reviewing all aspects of our...
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Jan 9, 2021
01/21
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KTVU
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the fda requires. conducted on medical devices to include a variety of patients, and they often are still the majority of study. subjects probably are light skinned, and there lies the problem. massimo is one of many medical device manufacturers pumping out home pulse ox emitters. the company heard about the concerns back in 2005. it was able to improve master most device, but says there's still work ahead in the medical device market. so medical professionals and manufacturers like what patients to stay vigilant, not worried. always remember no matter how wonderful the technology is. we have to see the patient. watch the patient and talk to the patient, and there's no substitute for that. it's certainly true now, doctor. i believe that says she like there to be usage guidance from medical professionals, and dr feiner says there will likely be follow up studies done in coming years to ensure all manufacturers have updated the devices. but in the meantime, catch dresses enough if you do use the device.
the fda requires. conducted on medical devices to include a variety of patients, and they often are still the majority of study. subjects probably are light skinned, and there lies the problem. massimo is one of many medical device manufacturers pumping out home pulse ox emitters. the company heard about the concerns back in 2005. it was able to improve master most device, but says there's still work ahead in the medical device market. so medical professionals and manufacturers like what...
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Jan 6, 2021
01/21
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tienen la opción de atenderse gratis en una de las clínicas de urgencias y evitar más dolor >>> la fdacho >>> además cambia el precio de la gasolina durante esta pandemia y le adelantamos que comienza ahorrar porque se parece que va a afectar su bolsillo. >>> qué tal amigos feliz martes vamos a hablar de las condiciones y posibles lluvias en los reyes magos tengo todas los detalles al volver. (comerciales) alámbricos. teléfonos con botones grandes y con más volumen. infórmese ya. visite o llame al durante el horario de atención. nadie sabe que necesitas ayuda. pero en covered california nadie es invisible. covered california te ofrece seguro médico con cobertura integral, incluyendo salud mental, aun con una condición preexistente. Último día de inscripción es el 31 de enero. ahora california phones le ofrece accesorios gratis para su teléfono celular. como este aparato para aumentar el volumen. infórmese ya. visite o llame al durante el horario de atención. [♪ ♪] [♪ ♪] [♪ ♪] >>> la fda está advirtiendo que tome la precaución para detectar al covid-19 y estarían dando falso negativo en
tienen la opción de atenderse gratis en una de las clínicas de urgencias y evitar más dolor >>> la fdacho >>> además cambia el precio de la gasolina durante esta pandemia y le adelantamos que comienza ahorrar porque se parece que va a afectar su bolsillo. >>> qué tal amigos feliz martes vamos a hablar de las condiciones y posibles lluvias en los reyes magos tengo todas los detalles al volver. (comerciales) alámbricos. teléfonos con botones grandes y con más...
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Jan 8, 2021
01/21
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KRON
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we need more specific information with the fda is asking you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news will put a link on our website as well kron 4 dot com and we'll move on now to talk about our weather forced it. >>forecast as we take a live look outside right now at the san mateo bridge. not raining there. i think the radar is going to stay dry for a few more days, let's check in now with our meteorologist mabrisa rodriguez to get details on what can expect especially for this weekend time agree self-pay there just hopefully you enjoyed the overnight showers that lasted through this morning because that's all we're going to see starting today. >>lasting for at least the next week tracking a lot of sunshine out there right now now that we've cleared out from the wet weather brought is about a 3rd of an inch of rain or less for most of the bay area, the highest amounts. no surprise. those of you in the north bay but tracking that drying in clearing trend out there right now wind speeds fairly calm in fact not even trackin
we need more specific information with the fda is asking you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news will put a link on our website as well kron 4 dot com and we'll move on now to talk about our weather forced it. >>forecast as we take a live look outside right now at the san mateo bridge. not raining there. i think the radar is going to stay dry for a few more days, let's check in now with our meteorologist mabrisa rodriguez...
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Jan 16, 2021
01/21
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CSPAN
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he was the fda commissioner through most of the 1990's under bill clinton. he is seen overall as a very competent figure. he has decades of experience in this realm of public health, and should be well suited taking a similar role for operation warp speed, kind of on the science side and driving that there is a pipeline of other vaccines we hope will work and be highly effective, and steering them through clinical trials and the regulatory process, that is what we should expect. host: scott in thomasville, georgia, you are next. caller: ok. i have a question. are you there? host: we are listening. caller: i have a question. i've been trying to get information about where i live in thomasville, georgia through the mayor's office and the health department, but they can't tell me when like people that are 50 with cardiac problems that are in that category, when we are going to get it. they told my mother and father they were going to get it next week because they are 70 and above, but when i was in the hospital getting my heart cath, i was told they were gettin
he was the fda commissioner through most of the 1990's under bill clinton. he is seen overall as a very competent figure. he has decades of experience in this realm of public health, and should be well suited taking a similar role for operation warp speed, kind of on the science side and driving that there is a pipeline of other vaccines we hope will work and be highly effective, and steering them through clinical trials and the regulatory process, that is what we should expect. host: scott in...
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Jan 9, 2021
01/21
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KRON
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is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>and the south bay, good news on covid is hard to come by when there is a daily average of 1200 new covid cases in santa clara county. but as kron four's rob fladeboe reports tonight health officials say the number of frontline health care workers getting vaccinated against the deadly virus is also on the rise. >>that clinics like this one on telly road in san jose and that hospitals and healthcare systems across the south bay. more than 47,000 health care workers have received their first doses of covid-19 vaccine. so far among them is willow glen family, dennis trees amy luna with our patients we want to make sure that they're they feel safe and comfortable so having the shot and being able to provide that comfort. >>is a good sense to ensuring that our all of our team is safe as well. amid the state's expanded eligibility for vaccinations to all healthcare personnel under phase, one a. >>the county is averaging 1500 vaccin
is saying you can go to their website which is fda dot gov. but for now in the north bay charles clifford kron 4 news. >>and the south bay, good news on covid is hard to come by when there is a daily average of 1200 new covid cases in santa clara county. but as kron four's rob fladeboe reports tonight health officials say the number of frontline health care workers getting vaccinated against the deadly virus is also on the rise. >>that clinics like this one on telly road in san jose...
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Jan 30, 2021
01/21
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mark mcclellan, former fda commissioner as you just heard, moderna is trying to get the fda to allow it to put more of the vaccine in each vial. thoughts on that >> shepard, that's an indication that we need to not only think about the production of the vaccines to get as many people vaccinated as quickly as possible, but all the supplies that go along with it. and as meg described, this fill and finish capacity, as it's called, is an area that can be a bottleneck and that's one where the new administration and governments elsewhere in the world can potentially take further steps to help along the partnerships that you're seeing form. many other manufacturers that aren't making the vaccines could potentially help, and the faster we can explore that capacity, the better >> dr. mcclellan, what are you going to say to this i don't want jonhnson & johnson. i want moderna or pfizer because they were better in the trials why am i wrong >> well, you did hear from meg that the -- and from dr. stofls that the j&j vaccine was tested. we're fighting a different virus today than we were three mo
mark mcclellan, former fda commissioner as you just heard, moderna is trying to get the fda to allow it to put more of the vaccine in each vial. thoughts on that >> shepard, that's an indication that we need to not only think about the production of the vaccines to get as many people vaccinated as quickly as possible, but all the supplies that go along with it. and as meg described, this fill and finish capacity, as it's called, is an area that can be a bottleneck and that's one where the...
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Jan 29, 2021
01/21
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if others go through the fda approval process, that is a positive step. he purchased these large orders for vaccines that we will have by the end of the summer to get into the arms of americans to ensure we could do that without any of those steps moving forward. >> he would encourage americans to get any vaccine approved id fda? press sec. psaki: we will not get ahead of the fda -- i am not suggesting you are asking that -- but we will rely on her experts to advise if there are additional vaccines that are approved by the fda and how that will impact our vaccine distribution plan. >> on the coronavirus release bill, in his first month, president obama traveled to a number of key states to gain support for the recovery act. does president biden have plans to do anything similar or his $1.9 trillion bill? press sec. psaki: then vice president biden also travel to a number of states at the time. obviously, we were not dealing with a pandemic. the circumstances were quite different. he fully recognizes the need to speak directly to the american people about
if others go through the fda approval process, that is a positive step. he purchased these large orders for vaccines that we will have by the end of the summer to get into the arms of americans to ensure we could do that without any of those steps moving forward. >> he would encourage americans to get any vaccine approved id fda? press sec. psaki: we will not get ahead of the fda -- i am not suggesting you are asking that -- but we will rely on her experts to advise if there are...
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Jan 29, 2021
01/21
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we leave that to the fda. go ahead. >> reporter: thank you. a couple questions on the economy starting with china. former president trump signed a phase one trade deal with beijing. does president biden consider that deal still to be in effect and does he expect china to meet its commitments under that deal? >> well, the national security team, the newly confirmed secretary of state, president biden, are all reviewing all aspects of our national security approach including certainly our relationship with china. you know, we are focused on approaching that relationship from a position of strength and that means coordinating and communicating with our allies and partners about how we are goings to work with china, it means strengthening our economy at home and it means, you know, determining the best path forward to address a range of issues not just economic, but strategic and also security. so, again, everything is under review, but i don't have anything for you on the -- more on the china relationship. >> reporter: to clarify, so it is still
we leave that to the fda. go ahead. >> reporter: thank you. a couple questions on the economy starting with china. former president trump signed a phase one trade deal with beijing. does president biden consider that deal still to be in effect and does he expect china to meet its commitments under that deal? >> well, the national security team, the newly confirmed secretary of state, president biden, are all reviewing all aspects of our national security approach including certainly...
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the fda for the first time issuing a warning against a proposal to speed up covid vaccinations just as more states threaten to punish hospitals that fail to give out shots quickly enough. >>> plus, growing concern about a new mutation of the virus spreading in the u.s. and now forcing a new national lockdown in the uk. >>> on the attack. >> there's nothing the radical democrats will not do to get power. >> president trump rallies voters in georgia just hours before polls open in today's crucial runoff with control of the u.s. senate up for grabs. why we may have to wait for a winner, plus a top election official in georgia who is a republican delivers a blistering rebuke of president trump's election fraud claim. >>> on alert. the national guard is activated bracing for potential violence as we await a decision on whether kenosha police officers will face charges in the shooting of jacob blake. what blake's father is requesting. >>> rescue on the slopes. a skier falling off this chair lift and left dangling by her jacket. >>> hawaii ufo, the mysterious object seen sailing across the sk
the fda for the first time issuing a warning against a proposal to speed up covid vaccinations just as more states threaten to punish hospitals that fail to give out shots quickly enough. >>> plus, growing concern about a new mutation of the virus spreading in the u.s. and now forcing a new national lockdown in the uk. >>> on the attack. >> there's nothing the radical democrats will not do to get power. >> president trump rallies voters in georgia just hours before...
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Jan 2, 2021
01/21
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would you get any of thatsu withouessful fda-approved vaccine? >> no, we will not. and we haven't -- first of all, weaven't received anything yet. secondly, we didn't receive the promise toeceive anything for the development of our vaccine or for the manufacturing, at risk. we are taking all the risk to manufacture the dose we have a contract that if we are successful, we will sell at a certain price -- 100 million doses to the u.s. government. and the contract clearly stipulates that if we fail to get the regulatory approvals, the government owes us nothing, and we just have to write off the product. i felt that we would move much m faster ah more reliable if i could protect my scientists from the bureaucracy. but when you get money, always comes with some strings attached. this is why we didn't get it. the level of risk you took on, as the c.e.o. of a publicly traded company, if it hadn't worked? >> it was high. very high. it was not going to break themp y. i'm not reckless. it took billions, right off. 's very painful for any corporation, even at our size. but i
would you get any of thatsu withouessful fda-approved vaccine? >> no, we will not. and we haven't -- first of all, weaven't received anything yet. secondly, we didn't receive the promise toeceive anything for the development of our vaccine or for the manufacturing, at risk. we are taking all the risk to manufacture the dose we have a contract that if we are successful, we will sell at a certain price -- 100 million doses to the u.s. government. and the contract clearly stipulates that if...
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Jan 28, 2021
01/21
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neutrogena® >> o'donnell: the fda tonight put >> o'donnell: the fda tonight put out an unprecedented that more than half of hand levf toxics ingredient. a ma jolter of the sampled tested by the fda contained methanol which can be deadly when ingested. shipments of hand sanitizers from mexico can now be detained by the fda and will be subjected to heightened scrutiny. hundreds of hundreds of americans have been poisoned by hand sanitizer this month including the overwhelming majority of them, children. now, here's some welcome news. making his debut was the panda cub born last august at the national zoo here in washington. you can only watch him on the pandacam while the zoo is xiao qi ji is up to 21 poundsf ah, they grow fast. and it was a nice break to get to watch that cute panda today. s adorable. all right, when we come back, "unifying america." a police chief atones for the past and works towards justice in the future. being a good father is important to me... ...so being diagnosed with advanced non-small cell lung cancer... ...made me think of all the things that i wanted to te
neutrogena® >> o'donnell: the fda tonight put >> o'donnell: the fda tonight put out an unprecedented that more than half of hand levf toxics ingredient. a ma jolter of the sampled tested by the fda contained methanol which can be deadly when ingested. shipments of hand sanitizers from mexico can now be detained by the fda and will be subjected to heightened scrutiny. hundreds of hundreds of americans have been poisoned by hand sanitizer this month including the overwhelming...
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Jan 16, 2021
01/21
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CSPAN
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we believe it is critical everybody should get two doses within the fda recommended timeframe. so we are not doing away without availability. fifth, we will always be honest and transparent about where we stand both the good news as well as the bad news. we will make sure state and local officials know how much supply they will be getting and when they can expect to get it so they can plan. right now we are hearing that they cannot plan. that they do not know how much supply of vaccines they can expect, and what timeframe. that stops when we are in office. we are also promising to provide regular updates to you, the american people, on our progress and our goals. we will be, i promise you, transparent about the decisions we are making and why we are making the decisions. you are entitled to know. our administration will lead with science and scientists. with the center for disease control, the national institute of health that will be free and totally free from political influence. a surgeon general who is independent and speaks directly to the american people, the fda's decisi
we believe it is critical everybody should get two doses within the fda recommended timeframe. so we are not doing away without availability. fifth, we will always be honest and transparent about where we stand both the good news as well as the bad news. we will make sure state and local officials know how much supply they will be getting and when they can expect to get it so they can plan. right now we are hearing that they cannot plan. that they do not know how much supply of vaccines they...
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Jan 28, 2021
01/21
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KRON
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we're not in compliance with the fda's regulations.e than half of the samples were found to contain toxic ingredients. >>state lawmakers announced new rules for big california company's next the data they company's next the data they must ♪ here's to the duers. to all the people who realize they can du more with less asthma thanks to dupixent, the add-on treatment for specific types of moderate-to-severe asthma. dupixent isn't for sudden breathing problems. it can improve lung function for better breathing in as little as 2 weeks and help prevent severe asthma attacks. it's not a steroid but can help reduce or eliminate oral steroids. dupixent can cause serious allergic reactions including anaphylaxis. get help right away if you have rash, shortness of breath, chest pain, tingling or numbness in your limbs. tell your doctor if you have a parasitic infection and don't change or stop your asthma treatments, including steroids, without talking to your doctor. are you ready to du more with less asthma? talk to your asthma specialist about
we're not in compliance with the fda's regulations.e than half of the samples were found to contain toxic ingredients. >>state lawmakers announced new rules for big california company's next the data they company's next the data they must ♪ here's to the duers. to all the people who realize they can du more with less asthma thanks to dupixent, the add-on treatment for specific types of moderate-to-severe asthma. dupixent isn't for sudden breathing problems. it can improve lung function...
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Jan 30, 2021
01/21
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i would tell you the department of health and human services, the fda, the team lead by dr. kessler, are hard at work answering all of those questions. so i will not use these briefings to talk about nonpublic information about pacific companies. all i can tell you is those are exactly the right factors we are thinking about. to make a broader point, the teamwork between everybody here, between the nih, cdc, fda, and our ability to understand what those doctors are, and turn it into actual actionable plans with manufacturers, is really important. i have been incredibly impressed so far with that. >> last question. you cut off. >> hello, pbs, thank you for taking my question, can you hear me? >> yes, i can. >> i have two questions. it sounded like you are saying we are vaccinating one million people daily. can you talk about the average goal and how quickly we ramp up to that? >> our 70 average is- one- 7-day averages 1.2 million and we view that as a floor and not a ceiling. we have task art team -- what we have cast our team vaccine horrible. there are two constraints right
i would tell you the department of health and human services, the fda, the team lead by dr. kessler, are hard at work answering all of those questions. so i will not use these briefings to talk about nonpublic information about pacific companies. all i can tell you is those are exactly the right factors we are thinking about. to make a broader point, the teamwork between everybody here, between the nih, cdc, fda, and our ability to understand what those doctors are, and turn it into actual...
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Jan 30, 2021
01/21
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KNTV
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. >> johnson & johnson says it's weeks away from asking the fire department -- fda approve for emergency use. compared to moderna and pfizer vaccines that are 95% effective. bay area dr. rodriguez. >> it's most effective, 85% effective in terms of preventing severe disease. >> the pfizer and moderna vaccines both work using mrna to teach the immune system to recognize and how to fight off the coronavirus. johnson & johnson's vaccine transports these into the body using a type of virus that causes the common cold. the new vaccine comes as new virus variants are raising concerns. to battle the changing virus dr. rodriguez says in the long term we will likely need a yearly shot. >> we will probably have to have yearly vaccines, perhaps, yearly covid vaccines to address the various variant that are arising. >> as experts consider the future, marin and sonoma county health officials are focused current vaccinations with limited supply it will likely take until the end of february to vaccine everybody 65 and older and until june to get a shot to everybody that wants one. >> a lot of questions
. >> johnson & johnson says it's weeks away from asking the fire department -- fda approve for emergency use. compared to moderna and pfizer vaccines that are 95% effective. bay area dr. rodriguez. >> it's most effective, 85% effective in terms of preventing severe disease. >> the pfizer and moderna vaccines both work using mrna to teach the immune system to recognize and how to fight off the coronavirus. johnson & johnson's vaccine transports these into the body using...
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Jan 9, 2021
01/21
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KTVU
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the fda doesn't do that, right. sports berg, an infectious disease specialist at uc berkeley, says physicians have reported complaints about their patients. it even happened on capitol hill, where curative aural self swab was used to test members of congress. they lost their citizens smell on taste. and in the eight all over the fever and a cough. i mean, they had covid. yet these tests were negative, and it was those kind of reports that led to the fda investigating and they found that there were just too many false negatives. puritans founder fred turner just 25 when he launched his startup released a statement saying, quote we're confident in our data, and we're working with the fda closely on the matter. testing sensitivity and accuracy on behalf of our patients is at the heart of our work. the company emphasizes. the test is on lee approved for people who are symptomatic lot of the problem is water under the bridge. extremely people who have been tested and you've carried on their lives thinking that they didn'
the fda doesn't do that, right. sports berg, an infectious disease specialist at uc berkeley, says physicians have reported complaints about their patients. it even happened on capitol hill, where curative aural self swab was used to test members of congress. they lost their citizens smell on taste. and in the eight all over the fever and a cough. i mean, they had covid. yet these tests were negative, and it was those kind of reports that led to the fda investigating and they found that there...
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Jan 9, 2021
01/21
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KTVU
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the fda doesn't do that, right.rg, an infectious disease specialist at uc berkeley, says physicians have reported complaints about their patients. it even happened on capitol hill, where curative aural self swab was used to test members of congress. they lost their citizens smell on taste. so the curative test is only recommended for people with symptoms. and so doctors say the fda warning is something that should be taken seriously. and they say if you have concerns that you might have a false negative, they suggest you get a second test and, of course, continue to quarantine andre. aren't animal, but reporting for us live apologize for that. little eruption. the package will try to get to it at six o'clock and thank you so m hundreds of thousands of restaurant workers lost their jobs last month during a new round of pandemic lockdowns. local restaurant groups are asking the city of san francisco to commit to so that restaurants can be prepared plus california. he's burning e can't last year old peter, you couldn't
the fda doesn't do that, right.rg, an infectious disease specialist at uc berkeley, says physicians have reported complaints about their patients. it even happened on capitol hill, where curative aural self swab was used to test members of congress. they lost their citizens smell on taste. so the curative test is only recommended for people with symptoms. and so doctors say the fda warning is something that should be taken seriously. and they say if you have concerns that you might have a false...
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Jan 31, 2021
01/21
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CSPAN
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what does the possibility of this drug being approved by the fda mean for this community? guest: it would be a very important step. it would represent the first drug approved on the basis on the fact that this drug would address the underlying disease itself and so the progression of the disease. that said, the degree of slowing would be incremental, perhaps on the order of a 20% slowdown. the question you might ask is, well, does that really make a difference? the reason why we leave this drug should be approved is not because of biogen or any other country -- company, but as a science-based organization we believe the science is sound for approval. we do think it would need continued study after approval, certainly, but the other part that way so heavily is what our constituents think about this. on that basis, with credit to the fda, they need an extra meeting to listen to advocates of those with the disease whom play -- you explain just how important that degree of slowdown and what it would mean for their ability to interact with loved ones and have greater independen
what does the possibility of this drug being approved by the fda mean for this community? guest: it would be a very important step. it would represent the first drug approved on the basis on the fact that this drug would address the underlying disease itself and so the progression of the disease. that said, the degree of slowing would be incremental, perhaps on the order of a 20% slowdown. the question you might ask is, well, does that really make a difference? the reason why we leave this drug...
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Jan 5, 2021
01/21
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former trump fda chief scott gottlieb writing in "the wall street journal" the major pharmacy chains combined can deliver up to 100 million a month. why not get started now? >> the idea that a vast majority of the vaccines we have produced are sitting in freezers across the country and not getting into people's arms is a crisis in the context of how much disease we have in the community >> reporter: today the medical workers who received a vaccinatio three weeks ago began returning for the required follow-up dose calls to delay the second dose or cut doses in half to protect more peopl largely opposed by health experts today moderna said it will up vaccine production by 20%. with the u.s. securing 100 million doses by the end of march another 100 million by june meanwhile wisconsin pharmacist steven brandenburg charged with deliberately destroying 500 vaccine doses appeared in virtually in court toda today after allegedly telling police he didn't think the vaccines were safe. >> tom, we know there's a couple more vaccine candidates coming down the pike when might they be approved >>
former trump fda chief scott gottlieb writing in "the wall street journal" the major pharmacy chains combined can deliver up to 100 million a month. why not get started now? >> the idea that a vast majority of the vaccines we have produced are sitting in freezers across the country and not getting into people's arms is a crisis in the context of how much disease we have in the community >> reporter: today the medical workers who received a vaccinatio three weeks ago began...
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Jan 2, 2021
01/21
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and i was hoping, frankly, t successes in the 70% umand fda was asking a min of 50%. to gethe minimum of more than 90% -- actually, much closer to 100% than to 90% -- is a very big -- very big achiev >> nearly 44,000 people participated in the trial. of those, 94 contracted covid-19. pfizer has announced that the vaccine is more than 9 effective. so does that mean, dr. bourla, that at least one ofhose 94 covid cases was contracted by someone who had received the vaccine? >> yes, correct. there were very, very few cases he the vaccinated group, and all the rest were inlacebo. this is how we calculated more than 90%. like i said, it between 90% and 100%. closer to the 100%. let me put it this way. >> so, pfizer was the first to reveal its findings on theth efficacy ovaccine. you were followed by another company, and you tweeted about that company... a number of other companies arei also in thl stages of trials. so, pfizer h plenty of't company, doet? >> yes, and we hope that many of them will be successful. we know very well that the demand for the vaccines will be so h
and i was hoping, frankly, t successes in the 70% umand fda was asking a min of 50%. to gethe minimum of more than 90% -- actually, much closer to 100% than to 90% -- is a very big -- very big achiev >> nearly 44,000 people participated in the trial. of those, 94 contracted covid-19. pfizer has announced that the vaccine is more than 9 effective. so does that mean, dr. bourla, that at least one ofhose 94 covid cases was contracted by someone who had received the vaccine? >> yes,...
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Jan 9, 2021
01/21
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KPIX
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la mayor was forced to defend the saliva test used there this week after the fda warned they carry a risk of false negative results for people who don't have symptoms. are they all created equal? >> there are dozens of tests and no, they're not. >> he explains each test of the emergency approval by the fda has slightly different sensitivity levels and some had no false negatives. >> how to the saliva tests compared to a nasal swab? >> there's more virus in the back of the throat with that deep nasal pharyngeal swap. >> there are two types of swabs, the deep invasive swab that is more likely to detect covid in those without symptoms or low levels of virus but he says he is comparable to the less invasive front enabled -- front nasal swab. they will meet the need for medical staff, making testing more accessible. ease-of-use is important but does that outweigh the reduced sensitivity? >> you don't want the perfect to be the enemy of good. >> reporter: testing exponentially means identifying more positive cases overall. even if some are missed. >> you don't have a perfect test at one th
la mayor was forced to defend the saliva test used there this week after the fda warned they carry a risk of false negative results for people who don't have symptoms. are they all created equal? >> there are dozens of tests and no, they're not. >> he explains each test of the emergency approval by the fda has slightly different sensitivity levels and some had no false negatives. >> how to the saliva tests compared to a nasal swab? >> there's more virus in the back of...
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Jan 12, 2021
01/21
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KRON
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say provides false results in some cases the fda says he oral swab tests produced by curative carry a risk of false negative result in asymptomatic people. the fda also says the curative test should only be used on symptomatic individuals within 14 days of a person showing symptoms. warren county currently uses his test at its pop-up testing sites and says it will continue to use curative tests at its pop-up site the county defended its decision saying that the test has a higher clinical sensitivity then most covid tests as california grapples with the effects of the pandemic the next few weeks will be crucial for governor newsome as he confronts a conservative led effort to recall him from office. >>the effort has collected 70% of the needed signatures before the march 10th deadline. secretary of state and future designated california senator alex for dia talks with the washington post today about the possibility of this effort being successful. >>but from all measures it seems like a lot of the same forces that have been behind trump. for the last four-plus years lot of same porti
say provides false results in some cases the fda says he oral swab tests produced by curative carry a risk of false negative result in asymptomatic people. the fda also says the curative test should only be used on symptomatic individuals within 14 days of a person showing symptoms. warren county currently uses his test at its pop-up testing sites and says it will continue to use curative tests at its pop-up site the county defended its decision saying that the test has a higher clinical...
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Jan 29, 2021
01/21
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CNNW
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we need to look at the data at the fda level. we have another vaccine which is highly effective at keeping you out of the hospital. that's an advantage in a situation where we don't have enough vaccines. so i think people need to consider that. were it me, were i not able to get the mrna vaccine and i only had the choice of johnson & johnson, i would take it assuming that the data look good as we look at the fda. i'd take it knowing there's probably a second dose trial out there which is likely to show it's even more effective. and knowing, worst case scenario, frankly, and this probably doesn't preclude you from get an mrna vaccine down the line. those two technologies shouldn't compete with each other. we'll have to generate those data. >> we should mention you are on the fda vaccine advisory committee. and so does this information that you are hearing this morning about j&j, does that change what you are thinking on there, what you would advise? >> it makes me hungry to see all the data. we will eventually see the 100 pages of
we need to look at the data at the fda level. we have another vaccine which is highly effective at keeping you out of the hospital. that's an advantage in a situation where we don't have enough vaccines. so i think people need to consider that. were it me, were i not able to get the mrna vaccine and i only had the choice of johnson & johnson, i would take it assuming that the data look good as we look at the fda. i'd take it knowing there's probably a second dose trial out there which is...
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Jan 29, 2021
01/21
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j & j plans to pile for fda
j & j plans to pile for fda
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Jan 30, 2021
01/21
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i don't want to get out ahead of the fda. the next several weeks, the fda has to go through all the data. the cdc committee called the acip has to study it and decide where and when and if it should be used. so i don't want to get out ahead. but i'm sitting here a lot more confident that we can take the morbidity and mortality out of this disease. >> dr. kessler, one of the things that you have talked about here on this show and that i've asked you about urgency, is the treatment. obviously we're trying to reduce the number of people getting infected and thereby reduce the number of people getting sick, but we've still got thousands of people getting infected every day. and having been personally terrified in seeing the progression of illness in someone who didn't have the worst of cases, didn't end up in the hospital, i want there to be progress on therapeutics, on treatment. you've talked about how that's a priority for you and the white house. >> we're looking at the monoclonal antibodies and we're learning more every day.
i don't want to get out ahead of the fda. the next several weeks, the fda has to go through all the data. the cdc committee called the acip has to study it and decide where and when and if it should be used. so i don't want to get out ahead. but i'm sitting here a lot more confident that we can take the morbidity and mortality out of this disease. >> dr. kessler, one of the things that you have talked about here on this show and that i've asked you about urgency, is the treatment....
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Jan 23, 2021
01/21
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CNNW
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first and only fda approved. celebrate less risk.ven for those with family history. ♪ don't take vascepa if you are... ...or become allergic to icosapent ethyl or any inactive ingredient in vascepa. serious side effects may occur like heart rhythm problems and bleeding. heart rhythm problems may occur in more people... ...with persistent cardiovascular risk or who have had them in the past. tell your doctor if you experience an irregular heartbeat or other heart rhythm problems. possible side effects include muscle and joint pain. celebrate less risk. added cardio protection. talk to your doctor about adding protection with vascepa. we are the thrivers. talk to your doctor about adding protection women with metastatic breast cancer,... ...standing in the struggle. hustling through the hurt. asking for science, not sorrys. our time... ...for more time... ...has come. living longer is possible- and proven in women taking kisqali plus fulvestrant or a nonsteroidal aromatase inhibitor. kisqali is the only treatment in its class with prov
first and only fda approved. celebrate less risk.ven for those with family history. ♪ don't take vascepa if you are... ...or become allergic to icosapent ethyl or any inactive ingredient in vascepa. serious side effects may occur like heart rhythm problems and bleeding. heart rhythm problems may occur in more people... ...with persistent cardiovascular risk or who have had them in the past. tell your doctor if you experience an irregular heartbeat or other heart rhythm problems. possible side...