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Jul 1, 2021
07/21
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CSPAN2
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. >> the acting head of the fda dr. janet woodcock testified about president biden's 2022 budget request before senate appropriations subcommittee. wisconsin senator tammy baldwin chairs the hearing. [inaudible conversations] [inaudible conversations] [inaudible conversations] >> good morning. i want to welcome everyone to our first budget hearing of this subcommittee for fiscal year 2022, and dr. woodcock. thank you so much for being here this morning. we are looking forward to your testimony and having a good discussion about the needs of the fda. the responsibilities of the fda are vast and have impact on every american. that's been made even clearer during our response to covid-19. we must continue to invest in safer drugs, safer medical devices and the safest food supply in the world. and for now and for the future. dr. woodcock, i'm looking forward to hearing your visions for the fda and what this committee can do to support your vital work. at work begins now with the fiscal year 2022 budget request that's in fro
. >> the acting head of the fda dr. janet woodcock testified about president biden's 2022 budget request before senate appropriations subcommittee. wisconsin senator tammy baldwin chairs the hearing. [inaudible conversations] [inaudible conversations] [inaudible conversations] >> good morning. i want to welcome everyone to our first budget hearing of this subcommittee for fiscal year 2022, and dr. woodcock. thank you so much for being here this morning. we are looking forward to...
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6.0
Jul 1, 2021
07/21
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CSPAN2
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to the fda, i would say this. no matter what your decision is on juul's pmt i, you know the problem doesn't end there. two and the use they think epidemic, you would have to deny applications for all products with the same characteristics that made juul so popular with the generation of children because we watched in real time whenever popular flavor is removed from the market, other flavored high nicotine products take their place. i safe to acting commissioner what crops, i believe you want to do the right thing, you want to keep nicotine out of the hands of children. when you decided to ban mental cigarettes, who took a strong action to strengthen public health and racial equity. when this committee exposed toxic heavy metals and vaping foods, you make that a priority created closer to zero initiative and we are appreciative.n however, now fda has the opportunity to step up and finish the fight against youth vaping epidemic. don't let any flavored products from any e-cigarette companies stay on the market, not
to the fda, i would say this. no matter what your decision is on juul's pmt i, you know the problem doesn't end there. two and the use they think epidemic, you would have to deny applications for all products with the same characteristics that made juul so popular with the generation of children because we watched in real time whenever popular flavor is removed from the market, other flavored high nicotine products take their place. i safe to acting commissioner what crops, i believe you want...
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Jul 29, 2021
07/21
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CSPAN3
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we presented our investigation to the fda, and fda agreed that joule was making the wall. it sent, juul a warning letter regarding marketing practices and declared them illegal. now juul's raitt fate is again in your hands at the fda. juul's products need your approval through what's called the premarket tobacco process. applications are due by september. juul's marketing to children was simply unacceptable. the attorney general of north carolina is taking juul to trial over that as we speak. beyond marketing, juul hooked kids for three other reasons. first, kids were attracted to the flavors juul cigarettes came in. second, kids got hooked because juul came in nicotine levels much higher than anything else on the market. and third, juuls from easy to conceal from adults. companies copied juul's model. when you look at the list of products that are the subject of pmta applications, there are many, many even now in kid-friendly flavors, there are many that match juul's high nicotine formulation, and many that match juul's concealability. to the fda, i would say this. no mat
we presented our investigation to the fda, and fda agreed that joule was making the wall. it sent, juul a warning letter regarding marketing practices and declared them illegal. now juul's raitt fate is again in your hands at the fda. juul's products need your approval through what's called the premarket tobacco process. applications are due by september. juul's marketing to children was simply unacceptable. the attorney general of north carolina is taking juul to trial over that as we speak....
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Jul 29, 2021
07/21
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CSPAN3
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eye 7
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we presented evidence from our investigation to fda and fda agreed that juul was breaking the law. it sent juul a warning letter regarding its marketing practices and declared them illegal. now juul's fate is again in your hands at the fda. juul's products and all e-cigarettes need fda's approval for their products to stay on the market through what's called the premarket tobacco application process, also known as the pmta process. fda's decisions are due by september. juul's marketing to children was simply unacceptable. the attorney general of north carolina is taking juul to trial over that as we speak, but beyond marketing juul hooked kids for three other reasons, first, kids were attracted to the flavors juul cigarettes came in. second, kids got hooked because juul came in nicotine levels much higher than anything else on the market. and third, juuls were easy to conceal from adults. companies copied juul's model. when you look at the list of products that are on -- that are the subject of pmta applications, there are many, many even now in kid-friendly flavors. there are many
we presented evidence from our investigation to fda and fda agreed that juul was breaking the law. it sent juul a warning letter regarding its marketing practices and declared them illegal. now juul's fate is again in your hands at the fda. juul's products and all e-cigarettes need fda's approval for their products to stay on the market through what's called the premarket tobacco application process, also known as the pmta process. fda's decisions are due by september. juul's marketing to...
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5.0
Jul 30, 2021
07/21
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CSPAN3
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eye 5
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fda can build. on the steps it's taken so far by prohibiting the sale of remaining favorite products, capping nicotine level in e-cigarettes, and pulling illegal product like those solved by puff barr off the market. i strongly urge the agency to take these common sense steps. let me conclude by commanding the leadership of chairman krishnamoorthi and the subcommittee on economic and consumer policy. the subcommittee's investigation has brought to light the dangerous practices of e-cigarette manufacturers across the country and it has underscored the urgent need for the federal government to act on america's youth vaping epidemic. thank you for your leadership, chairman krishnamoorthi. i look forward to hearing the testimony from or of our distinguished witnesses today, and i yield back. thank you. >> thank you chairwoman maloney, and thank you for your distinguished leadership. thank you for your opening statement. now i would like to begin by introducing our first panelist, someone i know very wel
fda can build. on the steps it's taken so far by prohibiting the sale of remaining favorite products, capping nicotine level in e-cigarettes, and pulling illegal product like those solved by puff barr off the market. i strongly urge the agency to take these common sense steps. let me conclude by commanding the leadership of chairman krishnamoorthi and the subcommittee on economic and consumer policy. the subcommittee's investigation has brought to light the dangerous practices of e-cigarette...
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Jul 11, 2021
07/21
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CSPAN
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by the fda. thank you. >> juul dominates the pre-filled pod market and ibts growth in market share has driven the rise in youth vaping rates. yet juul's pmta application proposes lifting marketing restrictions after just one year even though juul is currently on trial for marketing addictive and harmful products to children. juul has proven untrustworthy to continue selling its products and greatly contributed to the epidemic that we face today. so madam secretary, is the fda considering allowing juul products to be marketed again or has it made a decision to ban that practice or continue to ban that practice? >> those products are subject to a marketing application something newly introduced in to the market would have to go through the review process, as i understand it. >> has that happened yet? >> well, again, i can't discuss any single action that we might take. >> all right. thank you. >> if an application cannot prove with scientific evidence that the product will not contribute to or incr
by the fda. thank you. >> juul dominates the pre-filled pod market and ibts growth in market share has driven the rise in youth vaping rates. yet juul's pmta application proposes lifting marketing restrictions after just one year even though juul is currently on trial for marketing addictive and harmful products to children. juul has proven untrustworthy to continue selling its products and greatly contributed to the epidemic that we face today. so madam secretary, is the fda considering...
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6.0
Jul 2, 2021
07/21
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CSPAN2
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fda to my letters. i fear they are going to once again overvalue the unproven potential benefit of cessation for adult smokers while undervaluing the clear evidence of what's happening to our kids. only 4% of it up i don't use e cigarettes. 20% of high school students, kids who never would have picked up a tobacco product are vaping. it's simple, any product for the history of increasing youth use must be rejected by the food and drug administration,nc especialy flavored products we know hooks kids. this is a super bowl for the fda's tobacco effort. i'm afraid they're not ready for prime time. i hope they prove me time wrongd if announced plans to advance menthol cigarettes, important. i want to commend acting commissioner sitting behind me when she called mean with the news. just like a that, the time is nt for fda to take action and how it applies to public health standards and e cigarettes. we know fda after-the-fact enforcement warning letters in the game of lacrimal doesn't work. to put it bluntly,
fda to my letters. i fear they are going to once again overvalue the unproven potential benefit of cessation for adult smokers while undervaluing the clear evidence of what's happening to our kids. only 4% of it up i don't use e cigarettes. 20% of high school students, kids who never would have picked up a tobacco product are vaping. it's simple, any product for the history of increasing youth use must be rejected by the food and drug administration,nc especialy flavored products we know hooks...
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Jul 31, 2021
07/21
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CSPAN2
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and then urge the fda to approve today. two, urge fda to approve medicine for the subgroup today. three. and that expands access today. impasse the promising act to have rapidly progressing fatal diseases even beyond als. spent tens of thousands of patients are watching this from their homes wheelchair-bound some on life support, watching this today. there hope this in this hearing. some have waited and postponed their decision for suicide to see this hearing. i don't thank you understand what this hearing means to us. please do not let another generation of als patients die in pursuit of the purpose. please let this be the first generation to survive we want to live. you have the power to make it possible. thank you. >> i think there is applies from the entire als community offering your testimony. we are so in debt to you thank you for your clarity and your courage thank you for the patients you have exhibited today and i don't think that every single member of the subcommittee is moved by what you said and that we are determined to pursue exactly what you set out to do in your
and then urge the fda to approve today. two, urge fda to approve medicine for the subgroup today. three. and that expands access today. impasse the promising act to have rapidly progressing fatal diseases even beyond als. spent tens of thousands of patients are watching this from their homes wheelchair-bound some on life support, watching this today. there hope this in this hearing. some have waited and postponed their decision for suicide to see this hearing. i don't thank you understand what...
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Jul 16, 2021
07/21
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CNNW
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people should stop saying that is fda -- it's bs. i think misinformation is the main thing. >> i think it's both. >> i got to go. >> i want you -- i'm leaving. i'm leaving. you can't go, i love you, d lemon. >> what evs. talk to you season. this is don lemon tonight. this is what we do, this is what you should be doing, discussing with it people whether you agree or disagree. i'm going to be blunt here. i'm going to be blunt, and i want to you listen to me. misinformation is killing us. it's killing us. it's killing our democracy, litera literally killing us. the fact is people who refuse to be vaccinated and listen to the dies are propelling the spread of the virus. a virus that kills. misinformation is killing us. misinformation is killing us. just ask the surgeon general. >> millions of people don't have access to accurate information right now. because on social media platforms, we are seeing a rampant spread of misinformation and it's costing people lives. >> we know where a lot of misinformation is coming from. it's coming from
people should stop saying that is fda -- it's bs. i think misinformation is the main thing. >> i think it's both. >> i got to go. >> i want you -- i'm leaving. i'm leaving. you can't go, i love you, d lemon. >> what evs. talk to you season. this is don lemon tonight. this is what we do, this is what you should be doing, discussing with it people whether you agree or disagree. i'm going to be blunt here. i'm going to be blunt, and i want to you listen to me....
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Jul 10, 2021
07/21
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KNTV
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booster shots after pfizer said a third dose would offer more protection how the cdc and fda are pushing back dr. fauci is here to answer your questions. >>> two americans brought before the cameras today among the suspects in the assassination of haiti's president. what they've told authorities, and tonight word the fbi is joining the investigation. >>> president biden's new call with vladimir putin warning him again over relentless cyber attacks. >>> elsa slalamming the northeast, flooding new york subway stations and in the west another punishing heatwave more than 30 million under alert. >>> the head of the fda calling for investigation into a controversial alzheimer's drug >>> a new twist in the billionaire space race just hours before richard branson hopes to blast off into history. >>> and the 14-year-old whwho made history of her own at the national spelling bee. and that's not the only talent making her a star >> announcer: this is "nbc nightly news" with lester holt >> good evening. i'm peter alexander in for lester we begin tonight with two major headlines in the fight to comb
booster shots after pfizer said a third dose would offer more protection how the cdc and fda are pushing back dr. fauci is here to answer your questions. >>> two americans brought before the cameras today among the suspects in the assassination of haiti's president. what they've told authorities, and tonight word the fbi is joining the investigation. >>> president biden's new call with vladimir putin warning him again over relentless cyber attacks. >>> elsa slalamming...
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Jul 16, 2021
07/21
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CNNW
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people are putting too much emphasis on fda approval, when the fda approval, really, doesn't matter as much as people think. what matters is the efficacy and the vaccines are effective. >> 49% of people, who haven't been vaccinated, say it being fda approved would matter. >> i don't believe that. i think that's an excuse. >> that's what the number is. >> i know but i try to argue the numbers the other night. and you were saying, oh, it's perception. and so, maybe, that's part of perception, as well. >> what are you talking about? >> i was trying to give you facts, the other night. and you said, what mattered was -- the facts didn't really matter. perception was reality and it was a whole thing. whatever. i don't want to -- whatever. >> don. >> but it's the same thing about this. if the -- the facts of the matter is that the efficacy is what makes -- what makes a difference when it comes to the vaccine. not someone's idea about fda approval, when there is no research or facts to back it up. so maybe, 49% believe that. but what they are believing is not, actually, the truth. and our job
people are putting too much emphasis on fda approval, when the fda approval, really, doesn't matter as much as people think. what matters is the efficacy and the vaccines are effective. >> 49% of people, who haven't been vaccinated, say it being fda approved would matter. >> i don't believe that. i think that's an excuse. >> that's what the number is. >> i know but i try to argue the numbers the other night. and you were saying, oh, it's perception. and so, maybe, that's...
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Jul 16, 2021
07/21
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CNBC
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fda is movin >> i'm not sure the fda is moving slowly. my prediction was that it would take the fda three months from the time the applications were submitted from the agencies to issue full approval. pfizer submitted its application the end of may moderna submitted early june, so we're coming up about three months as we enter into the end of august. so i think that time frame is likely to hold i think it's likely to see the fda approve the vaccines somewhere around that three-month threshold. that was my assumption just understanding the fda process. >> the fda said today that vaccines for kids under 12 expected early to mid-winter that's a long way out. are you worried about the threat to kids between now and then especially in school >> well, look, the best protection we can afford kids is by controlling the spread of infection in adults. what we see in other countries is that when the rate of infection goes down the rate of infection goes down in children as well. if we can control the infection in the adult population, children are g
fda is movin >> i'm not sure the fda is moving slowly. my prediction was that it would take the fda three months from the time the applications were submitted from the agencies to issue full approval. pfizer submitted its application the end of may moderna submitted early june, so we're coming up about three months as we enter into the end of august. so i think that time frame is likely to hold i think it's likely to see the fda approve the vaccines somewhere around that three-month...
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Jul 15, 2021
07/21
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CNBC
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that was always my assumption based on just understanding the fda process. >> the fda said today that vaccines for kids under 12 expected like early to mid winter that's a long way out. are you worried about the threat to kids between now and then, especially in school >> well, look, the best protection we can afford kids is by controlling the spread of the infection in adults. what we have seen in other countries is when the rate of infection goes down in the adult population, the rate of infection goes down in children as well. if we can control the infection in the adult population, children are going to be less vulnerable the vaccine for children under the age of 12, so the vaccine being formulated for children ages 5 through 11, is a different vaccine in so far as it's a different dose. the dose that the adults are using and a dose that are being used in children above the age of 12 is a 30 microgram dose the vaccine pfizer is formulating for children ages 5 through 11 is a 10 microgram dose that's going to go through a separate evaluation process. fda typically views children 12
that was always my assumption based on just understanding the fda process. >> the fda said today that vaccines for kids under 12 expected like early to mid winter that's a long way out. are you worried about the threat to kids between now and then, especially in school >> well, look, the best protection we can afford kids is by controlling the spread of the infection in adults. what we have seen in other countries is when the rate of infection goes down in the adult population, the...
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do you agree with the cdc, the fda? they came out quickly saying this was simply too early to declare this. >> we've got to be guided by science and evidence and the science is clear, two shots offers a very high degree of protection. i haven't seen anything that says we need a third shot right now. obviously that might change, but right now, two shots is plenty. >> but you're not ruling out the possibility of a booster shot. >> no, in fact next year that may be a possibility. >> dr. jha, thank you as always. >>> in the meantime we move on tonight. the tropical storm elsa slamming the northeast with heavy rain and winds, gusting up to 60 miles per hour. look at the pictures tonight. drivers navigating through washed out roads in new york. torrential rain. we showed you some of this in new york city last night here. part of the subway system under water. the question, what comes next? across much of this country, the dangerous heat moving in. troubling lake levels already. let's get to sio ac hey, rob. >> reporter: hi, d
do you agree with the cdc, the fda? they came out quickly saying this was simply too early to declare this. >> we've got to be guided by science and evidence and the science is clear, two shots offers a very high degree of protection. i haven't seen anything that says we need a third shot right now. obviously that might change, but right now, two shots is plenty. >> but you're not ruling out the possibility of a booster shot. >> no, in fact next year that may be a possibility....
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Jul 10, 2021
07/21
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KGO
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do you agree with the cdc, the fda? they came out quickly saying this was simply too early to declare this. >> yeah, we've got to be guided by evidence and science on this and the data so far is very clear. two shots offers a very high degree of protection. i haven't seen anything that says that we need a third shot right now. obviously that might change, but as of right now, two shots is plenty. >> but you're not ruling out the possibility of a booster shot. >> no. at some point down the road, maybe next year, that may be a possibility. >> dr. jha, thank you as always. >>> in the meantime, we move on tonight. tropical storm elsa slamming the northeast today with heavy rain and winds, gusting up to 60 miles per hour. look at the pictures tonight. drivers navigating through washed-out roads in suffolk county, new york. flood waters rushing through new haven, connecticut. we showed you some of this in new york city over the last 24 hours last night here. parts of the subway system under water. the question, what comes nex
do you agree with the cdc, the fda? they came out quickly saying this was simply too early to declare this. >> yeah, we've got to be guided by evidence and science on this and the data so far is very clear. two shots offers a very high degree of protection. i haven't seen anything that says that we need a third shot right now. obviously that might change, but as of right now, two shots is plenty. >> but you're not ruling out the possibility of a booster shot. >> no. at some...
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Jul 8, 2021
07/21
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CNBC
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what the fda can do to help. stay with cramer >> announcer: don't miss a second of "mad money." follow @jimcramer on twitter have a question, tweet cramer, #madtweets send jim an email to madmoney@cnbc.com. or give us a call at 1-800-743-cnbc miss something head to madmoney.cnbc.com. it's another day. and anything could happen. it could be the day you welcome 1,200 guests and all their devices. or it could be the day there's a cyberthreat. get ready for it all with an advanced network and managed services from comcast business. and get cybersecurity solutions that let you see everything on your network. plus an expert team looking ahead 24/7 to help prevent threats. every day in business is a big day. we'll keep you ready for what's next. comcast business powering possibilities. ♪ ♪ ♪ digital transformation has failed to take off. because it hasn't removed the endless mundane work we all hate. ♪ ♪ ♪ automation can solve that by taking on repetitive tasks for us. unleash your potential. uipath. reboot work. well, would ya look at that! it was an accident. i was— spe
what the fda can do to help. stay with cramer >> announcer: don't miss a second of "mad money." follow @jimcramer on twitter have a question, tweet cramer, #madtweets send jim an email to madmoney@cnbc.com. or give us a call at 1-800-743-cnbc miss something head to madmoney.cnbc.com. it's another day. and anything could happen. it could be the day you welcome 1,200 guests and all their devices. or it could be the day there's a cyberthreat. get ready for it all with an advanced...
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9.0
Jul 10, 2021
07/21
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KDTV
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de tal manera que, la fda pueda aprobar la vacuna. ramÓn: muchas gracias por su participaciÓn, doctor. gracias por acompaÑarnos. ♪ ♪ [mÚsica] ramÓn: ayer por la tarde informamos del temblor registrado entre los lÍmites de nevada y california. suheily tiene mÁs informaciÓn. suheily: saludos. la actividad sÍsmica continÚa en la sierra nevada. tuvimos tres dÍgitos en el este de la bahÍa. 93° en santa rosa. fin de semana para prestar atenciÓn. aviso de calor extremo hasta las 11:00 del domingo. advertencia de calor en morgan hill y santa rosa. hay que tomar descansos en la sombra el fin de semana. evitar salir al aire libre en las horas de mÁs calor. la semana entrante con una mejorÍa en las temperaturas. hablamos de la actividad sÍsmica de ayer. el temblor de 5.9 fue ajustado a 6.0 no tenemos peligro relacionado. amanecemos con temperaturas en 60° para maÑana. el domingo con 85° en san josÉ. 96° en concord. vamos a la pausa. ♪ ♪ [mÚsica] aún queda tiempo en el reloj. willingham se acerca peligroso al área
de tal manera que, la fda pueda aprobar la vacuna. ramÓn: muchas gracias por su participaciÓn, doctor. gracias por acompaÑarnos. ♪ ♪ [mÚsica] ramÓn: ayer por la tarde informamos del temblor registrado entre los lÍmites de nevada y california. suheily tiene mÁs informaciÓn. suheily: saludos. la actividad sÍsmica continÚa en la sierra nevada. tuvimos tres dÍgitos en el este de la bahÍa. 93° en santa rosa. fin de semana para prestar atenciÓn. aviso de calor extremo hasta las...
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Jul 10, 2021
07/21
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KNTV
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. >>> the head of the fda calling for investigation into a controversial alzheimer's drug >>> a new twist in the billionaire space race just hours before richard branson hopes to blast off into history. >>> and the 14-year-old who made history of her own at the national spelling bee. and that's not the only talent making her a star >> announcer: this is "nbc nightly news" with lester holt >> good evening. i'm peter alexander in for lester we begin tonight with two major headlines in the fight to combat covid. the cdc releasing new guidance for schools, urging them to fully reopen this fall for in-person learning, saying those who are vaccinated do not need masks, and those who are not should wear them after the news we told you about last night, that pfizer is developing a booster shot to target the delta variant, the fda and cdc now say those who are fully vaccinated do not need a booster. i just asked dr. anthony fauci about all of it. we will have that in a moment but we begin with late-breaking details from miguel almaguer. >> how you doing >> reporter: when fully vaccinated students
. >>> the head of the fda calling for investigation into a controversial alzheimer's drug >>> a new twist in the billionaire space race just hours before richard branson hopes to blast off into history. >>> and the 14-year-old who made history of her own at the national spelling bee. and that's not the only talent making her a star >> announcer: this is "nbc nightly news" with lester holt >> good evening. i'm peter alexander in for lester we...
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Jul 21, 2021
07/21
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CNNW
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why isn't there full fda approval and is there a way to fast track it? >> based on the analysis the fda has done so far, there's three vak si neighs and they are very safe and very effective. that conclusion is not going to change as a result of the full approval of a vaccine. the full approval is for making this vaccine available not just in the public health emergency but for all time. hopefully one of these days we get to a point where we got covid under more control. it's in the background. it's something we need to make sure we have immunity against. the fda wants to be sure the vaccine is safe and effective for long times and requires a lot longer term data. studies how long the vaccine can last in storage on the shelf. it's a lot of long term issues. it's not going to effect the short term use of the vaccine but very important for making sure this is going to be there and something we can count on for the long term. i hear you. i have done panels for vaccine l he has tants people and they said they won't feel comfortable until there's approval. >>
why isn't there full fda approval and is there a way to fast track it? >> based on the analysis the fda has done so far, there's three vak si neighs and they are very safe and very effective. that conclusion is not going to change as a result of the full approval of a vaccine. the full approval is for making this vaccine available not just in the public health emergency but for all time. hopefully one of these days we get to a point where we got covid under more control. it's in the...
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Jul 25, 2021
07/21
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MSNBCW
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could full fda approval convince enough people to get vaccinated? >>> also, a nationwide ban on evictions is about to expire. what can people do. we will get into that with former hud secretary julian castro. from nbc news world headquarters in new york, i'm joshua johnson. welcome to "the week." p let's start this saturday night with some new developments in the prosecution of the so-called qanon shahman, one of many people facing charges over the january 6th riot at the u.s. capitol. attorneys for jacob chancelee tell nbc news they're working toward a plea deal. mr. chansley faces charges of civil disorder, obstruction and disorderly conduct. according to the government's aorder the government has acknowledged he neither led the charge into the capitol nor behaved violently during the riot. meanwhile as we said former president trump is holding a rally tonight in phoenix. rioters like jacob chansley say they attacked the capitol because they believed the baseless claims of a stolen election. but we gained new insight this week into donald trump's
could full fda approval convince enough people to get vaccinated? >>> also, a nationwide ban on evictions is about to expire. what can people do. we will get into that with former hud secretary julian castro. from nbc news world headquarters in new york, i'm joshua johnson. welcome to "the week." p let's start this saturday night with some new developments in the prosecution of the so-called qanon shahman, one of many people facing charges over the january 6th riot at the...
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Jul 25, 2021
07/21
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CSPAN
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>> they aren't fda's contracts. my understanding is it is possible under eua to do exports and that could be possible. but we can get back to you on that, because it really isn't an fda issue. >> sounds great. next, as regards dr. fauci or dr. walensky, it does seem to me this issue of whether or not we need a booster would be ascertainable by whether or not we can see a response of antibody to rechallenge within the window period of four days for the virus between exposure and onset of infection if the antibodies shoot up rapidly we've got protection. are any studies taking place along these lines? >> absolutely, both within the government and within the companies. we certainly are -- the government as a whole, the agencies involved are monitoring this very carefully and we're sharing all the data. >> these are very simply done and don't have a lot of time frame. obviously the window period is only four days. >> right. >> i've asked about this before but there doesn't seem to be any answers. what is the delay? >> a
>> they aren't fda's contracts. my understanding is it is possible under eua to do exports and that could be possible. but we can get back to you on that, because it really isn't an fda issue. >> sounds great. next, as regards dr. fauci or dr. walensky, it does seem to me this issue of whether or not we need a booster would be ascertainable by whether or not we can see a response of antibody to rechallenge within the window period of four days for the virus between exposure and...
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Jul 1, 2021
07/21
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CSPAN2
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i know that pfizer and madonna have provided data to the fda and the fda is working on an expedited time frame but doctor fauci, you might want to talk about the experience we have with the vaccines, the hundreds of millions and what that can tell people about their safety and efficacy. >> as always we don't want to get ahead of the fda. they have their process where they need to cross all the keys and not all the eyes but if you look at the history of emergency use authorizations, they use for a wide range of emergency approval of interventions. often the criteria is to the benefit appears to be better than the risk involved. very infrequently, do you have such an extraordinary amount of data of literally hundreds of millions of doses and a lot of real world effectiveness data as well as safety having been cumulated. so again, although it's understandable how some people will say we really want to wait for full approval, and have an emergency use authorization is to have this amount of extraordinarily positive data , one would say again, be happy, you never want to get ahead from the fd
i know that pfizer and madonna have provided data to the fda and the fda is working on an expedited time frame but doctor fauci, you might want to talk about the experience we have with the vaccines, the hundreds of millions and what that can tell people about their safety and efficacy. >> as always we don't want to get ahead of the fda. they have their process where they need to cross all the keys and not all the eyes but if you look at the history of emergency use authorizations, they...
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Jul 13, 2021
07/21
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KPIX
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the fda says the johnson & johnson shot could be linked to a rare disorder. how it attacks the nervous system and the number of people affected so far. >>> there is nothing special about this special session. this is a suppression session. >> texas revolt. democrats leave the state to block a voting restrictions bill. how long they plan to stay away. >>> confrontations in cuba. president biden weighs in on the historic mass protests on the island nation. >>> good morning. good to be with you. i'm anne-marie green. we begin with the fda's new warning about the johnson & johnson covid vaccine shot. the agency says the single dose vaccine is possibly linked to a rare autoimmune disorder that could lead to paralysis. but it's still urging people to get inoculated as the daily number of covidhe country by 30. laura podesta is in new york. laura, what more do we know about this rare side effect? >> reporter: good morning, anne-marie. it's called guillen-barre syndrome and symptoms present as tingling in the hands and toes. a small percentage of people die and most
the fda says the johnson & johnson shot could be linked to a rare disorder. how it attacks the nervous system and the number of people affected so far. >>> there is nothing special about this special session. this is a suppression session. >> texas revolt. democrats leave the state to block a voting restrictions bill. how long they plan to stay away. >>> confrontations in cuba. president biden weighs in on the historic mass protests on the island nation. >>>...
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Jul 19, 2021
07/21
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CSPAN
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the fda can help small businesses and entrepreneurs drive in rural areas. i am the ceo of the rural community partnership. a network of nonprofit partners providing a technical assistance, training and resources to rural and tribal communities in every state, territory and tribal land. through regional partners, more than 300 technical assistance provider's capacity to strengthen for all areas. our approach is grounded in long-term trusted relationships with thousands of rural communities across the country. last year we served 3.4 million rural and tribal residents in 2000 community's. with an average population of 1500 and median household income of half the national average. people of color represented 21% of world population and 83% of rural population growth. it's increasingly diverse. innovation and resiliency of america's rural areas will play a central role in the future of u.s. capitol. covert exacerbated challenges for rural communities as they have not fully recovered get from the 2008 recession. now is the time for real sustained change. small b
the fda can help small businesses and entrepreneurs drive in rural areas. i am the ceo of the rural community partnership. a network of nonprofit partners providing a technical assistance, training and resources to rural and tribal communities in every state, territory and tribal land. through regional partners, more than 300 technical assistance provider's capacity to strengthen for all areas. our approach is grounded in long-term trusted relationships with thousands of rural communities...
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Jul 29, 2021
07/21
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CNNW
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but erin, for the reasons that you said, fda that people -- the fda is not cutting any corners on this. it's like working 24/7 but doing the full load. i want to make clear, though, that emergency authorization, what we have now is not -- it's not experimental authorization. so the fda is going to be using the same evidence that has already been incorporated or showing that these vaccines are very safe and effective. it's just taking extra steps like making sure the vaccines can sit in a freezer for a year safely. other things for normal times. this is not normal times, erin. >> you're saying that there is no difference between emergency and actual authorization when it comes to safety or efficacy. >> that's right. and all of the information, all of these very large clinical trials, data on millions of people already being incorporated and updated in the guidance that the fda puts out, that the centers for disease control puts out, all of that is being taken into account. so people have a lot of confidence, even now. >> israel announced it's rolling out a third dose of the covid vaccin
but erin, for the reasons that you said, fda that people -- the fda is not cutting any corners on this. it's like working 24/7 but doing the full load. i want to make clear, though, that emergency authorization, what we have now is not -- it's not experimental authorization. so the fda is going to be using the same evidence that has already been incorporated or showing that these vaccines are very safe and effective. it's just taking extra steps like making sure the vaccines can sit in a...
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Jul 21, 2021
07/21
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CSPAN
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that is more of an fda. dr. woodcock: basically, to do that, we need to get the manufacturers to change how they are manufacturing the drug and what the storage conditions might be and things like that. i think a rogue efforts are being made to try and get vaccines that don't acquire deep freezing storage conditions and that could be open up into smaller groups and stored in pediatricians offices and refrigerators. that is the ideal here. so that pediatricians and others could -- primary care, at the pharmacy, the nursing home pharmacy, as new people come in, they can vaccinate them without wasting large amounts of vaccine or having to break into something in a deep freeze. those efforts are arduously going on. they are highly technical and they are not simple. i think the government is uniting with manufacturers make this a reality as necessary. >> thank you for being here. dr. walensky, you have been in your post since january. you have surely for critiques of the job. you usually learn from some things that h
that is more of an fda. dr. woodcock: basically, to do that, we need to get the manufacturers to change how they are manufacturing the drug and what the storage conditions might be and things like that. i think a rogue efforts are being made to try and get vaccines that don't acquire deep freezing storage conditions and that could be open up into smaller groups and stored in pediatricians offices and refrigerators. that is the ideal here. so that pediatricians and others could -- primary care,...
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Jul 29, 2021
07/21
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CNNW
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the head of the fda and other senior people at the fda have come out and said the best thing you can do is get vaccinated. so, they're not neutral on this. they're out there advocating, and yet they've fallen short of approving the entire vaccine, which has precisely the problems you've laid out. it raises doubts among people who maybe they're looking for reasons to have doubts, but it raises doubts. and second of all it makes it harder for companies and organizations to mandate the vaccine. if the fda says we don't know yet, this is an emergency product, that would be one thing. but instead the leaders are out there endorsing the vaccine loudly at the same moment they're not doing the most important thing that would lead people to do exactly what they're telling people to do, which is get vaccinated. that's just not clear speaking. >> david's also written about the need for clarity with break through data, which is, by the way -- i apologize -- not to david. he knows everything -- but to you watching wherever you are. that is a confusing term. we've never used it before and we just
the head of the fda and other senior people at the fda have come out and said the best thing you can do is get vaccinated. so, they're not neutral on this. they're out there advocating, and yet they've fallen short of approving the entire vaccine, which has precisely the problems you've laid out. it raises doubts among people who maybe they're looking for reasons to have doubts, but it raises doubts. and second of all it makes it harder for companies and organizations to mandate the vaccine. if...
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Jul 9, 2021
07/21
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CNNW
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pfizer is going to have to give the data to the fda. the fda is going to have an external advisor who is going to look at that data and give them their advice and in the end, the fda and regulators make the rules and will determine how and when the vaccine doses are used. >> okay. so i totally understand what you're saying, you know, and i'm not asking you to weigh into politics but dr. fauci saying the cdc and fda saying if you've been fully vaccinated at this time, you don't need a booster shot. it's problematic. it sends a signal that the science is confusing and i think that's troubling and may be a messaging issue on the part of government. i mean, do you think that when they see this information they're going to go oh, wait a minute, guess what? pfizer is right? >> you know, for those of us that are making vaccines for a long time, it is not unusual for immune responses after vaccination to wayne over time. what is the crucial point, though and which we don't know the answer to right now is even though that immunity wanes over tim
pfizer is going to have to give the data to the fda. the fda is going to have an external advisor who is going to look at that data and give them their advice and in the end, the fda and regulators make the rules and will determine how and when the vaccine doses are used. >> okay. so i totally understand what you're saying, you know, and i'm not asking you to weigh into politics but dr. fauci saying the cdc and fda saying if you've been fully vaccinated at this time, you don't need a...
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the cdc and fda say it is not needed now. studies show that the two shot vaccine can protect people from the variant. >>> a sign people are getting back to normal. bart system wide will be back to prepandemic scheduling. that means trains every 15 minutes between 5 a.m. and 12 midnight. >>> number seven, a world report could be broken today in concord, the two men vying for the title of the longest teeter-totter ride, expected to hit 216 hours today. that is the existing record. >>> british billionaire richard branson is days away from a launch into space on the virginiaen galactic space ship. >> reporter: counting down to the billionaire blast off. richard branson is set to beat jeff bezos by just nine days in what has been dubbed the billionaire space race. i pnteda ra. i don' think of us feel that way. >> reporter: there will be five employees for the flight. abc spoke with astronauts on the international space station days ago. >> i think it is good. i think you need momentum and being competitive is kind of part of the p
the cdc and fda say it is not needed now. studies show that the two shot vaccine can protect people from the variant. >>> a sign people are getting back to normal. bart system wide will be back to prepandemic scheduling. that means trains every 15 minutes between 5 a.m. and 12 midnight. >>> number seven, a world report could be broken today in concord, the two men vying for the title of the longest teeter-totter ride, expected to hit 216 hours today. that is the existing...
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Jul 9, 2021
07/21
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CNNW
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the fda and cdc said, to be clear, we're not quite there yet. the two top federal agencies issued a joint statement claiming that more data is needed before authorizing a third dose of the vaccine, saying, quote, americans who have been fully vaccinated do not need a booster shot at this time. that's a key message. joining me now, cnn's senior medical correspondent elizabeth cohen. elizabeth, i wonder how folks at home should look at this, particularly those already vaccinated. i mean, could this be pfizer preparing for the worst here if these variants get worse, right, but the fda and cdc saying, listen, the data shows that for now those vaccines protect you? >> jim, it's a little bit unclear what is happening here. usually drug companies and especially the fda are very sort of coordinated in their messaging. so it is unclear what's happening here because this is the big picture. the big picture is that one-third of americans have chosen not to get vaccinated, and so obviously they have some concerns about these vaccines. and so now pfizer is s
the fda and cdc said, to be clear, we're not quite there yet. the two top federal agencies issued a joint statement claiming that more data is needed before authorizing a third dose of the vaccine, saying, quote, americans who have been fully vaccinated do not need a booster shot at this time. that's a key message. joining me now, cnn's senior medical correspondent elizabeth cohen. elizabeth, i wonder how folks at home should look at this, particularly those already vaccinated. i mean, could...
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Jul 10, 2021
07/21
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KNTV
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previous was when the fda fully approved one of the vaccines. stanford health care is requiring staff to be vaccinated by august 15th, saying in statement we join increasing number of health systems nationally taking this action with urgency, particularly in light of the emerging threat of highly infectious variants. the mandate will save lives. >> hospitals push that again. that is you shouldn't be in a hospital as health care worker if you're not vaccinated. risk to yourself and sick people. >> reporter: he also says as the virus continues to spread, highly contagious delta variant won't be only threat. >> you're producing billions of viral particles because you're not immunized. some will become variants that survive. >>> parents are asking whether children have to wear masks returning to school next month. cdc is dropping requirement to wear masks indoors if people are vaccinated. but state health department and many school districts in california require them to continue wearing masks despite the vaccination status. most elementary school s
previous was when the fda fully approved one of the vaccines. stanford health care is requiring staff to be vaccinated by august 15th, saying in statement we join increasing number of health systems nationally taking this action with urgency, particularly in light of the emerging threat of highly infectious variants. the mandate will save lives. >> hospitals push that again. that is you shouldn't be in a hospital as health care worker if you're not vaccinated. risk to yourself and sick...
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Jul 10, 2021
07/21
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BBCNEWS
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they all submit all of their data to the fda, the fda will massage it for a while and then there will be a select committee that is not part of the fda but advises the fda, that will then massage it further and will make a recommendation. and almost always, but not always, the fda follows that select committee's recommendation. then it goes to the cdc where the cdc will massage the data. they have another committee that's independent of the cdc, that advises the cdc, called acip — they'll do the same thing and, ultimately, give their blessing, or not, to the cdc. so it's somewhat serpentine, how they're going to get there. this comes amid rising cases of the delta variant causing concern here in the uk, also across large parts of asia. there are also variants which are of interest, not yet of concern, but of interest, such as the lambda variant which we've heard about. how important is it to update vaccines to keep up the pace with these variants? well, the good news is that to date there is no variant that reliably, or predictably, will escape the vaccines — the immunity we get f
they all submit all of their data to the fda, the fda will massage it for a while and then there will be a select committee that is not part of the fda but advises the fda, that will then massage it further and will make a recommendation. and almost always, but not always, the fda follows that select committee's recommendation. then it goes to the cdc where the cdc will massage the data. they have another committee that's independent of the cdc, that advises the cdc, called acip — they'll do...
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Jul 11, 2021
07/21
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FOXNEWSW
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, still it will be fully fda approved. that is one of the main issues that many americans who are not vaccinated are waiting for. there are a small amount of americans that are not vaccinated or do not want to be, majority of us are vaccinated or willing to. the most important thing is understand that vaccines save lives, i have seen it first hand. this past month, every one of my patients that tested positive for covid was not vaccinated. i have not had one patient who had to be hospitalized after being vaccinated if they did contract the virus. remember if you are unvaccinated, you are vulnerable to the virus, especially the delta virus which is circulating, we're seeing states like alabama and arkansas, they have low level of vaccination rates, that is where we are seeing the outbreaks, vaccine hesitancy is a real global health threat it results in outbreak and disease and death, one of the greatest obstacles we are combating on a daily basis, misinformation and irrational distrust of the vaccine. we're working day and
, still it will be fully fda approved. that is one of the main issues that many americans who are not vaccinated are waiting for. there are a small amount of americans that are not vaccinated or do not want to be, majority of us are vaccinated or willing to. the most important thing is understand that vaccines save lives, i have seen it first hand. this past month, every one of my patients that tested positive for covid was not vaccinated. i have not had one patient who had to be hospitalized...
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Jul 21, 2021
07/21
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CSPAN2
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it is not fda approved. president trump should be proud of the accomplishment his administration made along with vice president pence, they worked very hard on it and it's a miracle for them to come up with the vaccine in such a short amount of time. what i am saying is it should not be forced or mandated. information needs to be found out. there are reports of side effects and obviously reports of death and i think these are important things to check out before it fda approved. here we have requirements for students to be vaccinated before students can return to college. we just had this young lady who lost her scholarship, i believe $200,000 scholarship and flew lost her scholarship because she doesn't want to get the vaccine, her doctor said it would put her at high risk because of the medical condition she currently has. there is a 13-year-old boy in michigan who just recently died after taking the vaccine. you see, there's a lot of things happening and i think it's important for us to analyze all of thi
it is not fda approved. president trump should be proud of the accomplishment his administration made along with vice president pence, they worked very hard on it and it's a miracle for them to come up with the vaccine in such a short amount of time. what i am saying is it should not be forced or mandated. information needs to be found out. there are reports of side effects and obviously reports of death and i think these are important things to check out before it fda approved. here we have...
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Jul 9, 2021
07/21
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CNNW
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>> certainly they need to the cdc and the fda. the fda being the regulatory authority that has control over this. and the cdc will make the recommendation. certainly pfizer is doing their own studies, which is good. i'm pleased they're doing that. as they have indicated, they will ultimately apply to get authorization to give a boost. however, right now, as said by the cdc and the fda in their joint statement that they came out with last night, that right now people who have gotten the doses of pfizer, the prime and the boost as well as the prime and the boost of moderna or a single dose of j&j do not need to get a boost right now. having said that, the fda, cdc and nih are gathering information through studying to determine if and when we might need boosters. but that's not right now. nothing is changed with regard to the cdc's recommendations. so we respect what the pharmaceutical company is doing. but the american public should take their advice from the cdc and the fda. >> the former surgeon general of the united states, dr. j
>> certainly they need to the cdc and the fda. the fda being the regulatory authority that has control over this. and the cdc will make the recommendation. certainly pfizer is doing their own studies, which is good. i'm pleased they're doing that. as they have indicated, they will ultimately apply to get authorization to give a boost. however, right now, as said by the cdc and the fda in their joint statement that they came out with last night, that right now people who have gotten the...
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Jul 13, 2021
07/21
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MSNBCW
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the fda warning of an increased risk for a rare neurological disorder. this hour i'll be speaking with dr. anthony fauci, the president's chief medical adviser, but first to our top story, voting rights. joining us now texas state representative ann johnson one of 50 lawmakers to protest against republican state efforts against access and who will be with president biden for his major voting rights speech. welcome to both of you. ann johnson, great to hear from both of you. you had a late night, your escape from texas. you and your colleagues are going to be arrested and that the house voting moments ago, in fact, for the sergeant at arms to track you all down. >> a number of my colleagues and i watched as an arrest was put out for us not recognizing that we are in d.c. because this is now the only place where we can do our job. governor abbott said let's get down to business and that's where we wanted to be, but he's not interested in getting down to the business of texans who want to talk about the failing power grid, who want to talk about covid. inst
the fda warning of an increased risk for a rare neurological disorder. this hour i'll be speaking with dr. anthony fauci, the president's chief medical adviser, but first to our top story, voting rights. joining us now texas state representative ann johnson one of 50 lawmakers to protest against republican state efforts against access and who will be with president biden for his major voting rights speech. welcome to both of you. ann johnson, great to hear from both of you. you had a late...