the purpose of the fda. i think you can standardize safety pretty well. the fda focuses on that. are you also focusing on efficacy to such an extent that you cannot really standardize it? with something like stem cell therapy, which is clearly safe, is the fda getting in the way of it trying to standardize the efficacy of it in a very unreasonable way? are we looking at a paradigm shift on that? dr.cavazzoni: we take that approach where we want to be as flexible as possible, understanding that there is a higher tolerance for safety. we also, as a situation like accelerated approval, we also accept when in the appropriate instances, the fact that there may be some residual uncertainty about c. this is an inherent there's about advocacy. this is an inherent element of the accelerated approval package which we have used in many situations. and, more medical needs such as oncology, read to see this, and infectious in the this -- where -- herrera --rare diseases, and infectious diseases. >> the chair recognizes a gentlewoman from washington state, dr. schreier for five minutes for que

fda vaccination approval. >> and thank you for joining us. i'll turn to doctors walensky, fauci, and murthy after i provide a brief update. we havee progress on vaccinations in just seven months, with more than 200 million americans now with at least their first shot and 171 million americans fully vaccinated. but we can't and we won't let up. we're now in a pandemic of the unvaccinated, and the way to end this pandemic is more vaccinations. more vaccinations that's exactly what we're getting done. nationwide, we've gotten a total of 6 million shots in arms in the last seven days. that's the highest seven-day total in over a month and a half. and at the end of last week, for three straight days, we got more than 1 million shots in arms each day. that's the first time that's happened since june. importantly, we've dramatically increased the number of people getting their first shots each day. back in mid-july, we were averaging 260,000 first shots in arms per day. today, we're getting 450,000 first shots a day more than a 70 percent increase.

if fda had a similar authority for conditional approval pathways, or that give the fda more flexibility in getting, saying therapies -- in getting promising therapies to patients that are dying sooner? does the fda seek that kind of legislation in congress? for conditional approval? >> thank you. that is an important question. when it comes to approaches to development of a drug. we think we have a lot of tools at our disposal. the limiting factor in applying the tools we have is the lack of understanding of the biology of the diseases. we are eager to work with sponsors to identify some of the biomarkers and markers of the disease that would allow us to realize our expedited pathway including accelerated approval in neurodegenerative diseases. >> my time is expired. the chair now recognizes mr. guthrie, a ranking member. -- our ranking member. >> as you know, the nih brain initiative is intended to produce a revolutionary new my dynamic map of the brain that can show ohio individual cells -- how individual cells interact. how would this initiative improve our knowledge of neurodegenera

pfizer today granted full fda approval for its vaccine. the hope now is that americans who have been waiting for a

the fda approval is the gold standard. as i just said, now it has been granted. those who have been waiting for full approval should yogo get your shot no. the vaccination is free, easy, safe and effective and it is convenient. for 90% of americans, there is a vaccination site less than five miles from your home. and you can get. the shot without an appointment so, please get your shot today. julian: we are joined now by ucsf infectious disease specialist dr. monica, a steady voice throughout's entire pandemic. thanks for joining us. let's start with the big news. 200 million pfizer doses have been administered in the u.s. hundreds of millions more under the emergency provision worldwide since december. what is this full fda approval that we heard the president talk about mean for all of us? >> i think it is an exciting day. it is a big deal that i got approved for two reasons. one is what president biden said is true, there are some people waiting for this full approval together vaccine. there was a psychological kind of impediment to signing a consent form for

let's talk about this fda decision. what factors led the agency to conclude that this vaccine, pfizer, is ultimately safe and effective for everyone? >> kate, when they first got the emergency use authorization the fda used two months of data for all the different vaccines to give them that temporary emergency use authorization which would expire when the pandemic expired or ended, hopefully very soon here. but when they started doing this full approval, they actually started back in may giving six months of data after their volunteers got vaccinated. looking at the six months of data it took the fda three months to go through the data and looking at safety and efficacy and the effectiveness, but also looking at the manufacturing process to make sure the quality is going there and making sure that the manufacturer is going to have continued follow up. because as president biden said, this is a full, this is a full approval, a permanent approval. not something they're going to easily rescind. so, moving forward like we m

big news from the fda. the federal agency has granted full approval to pfizer's vaccine, making it the nation's first to move beyond the emergency use authorization. here's the possible impact here. this full approval might prompt a lot of those skeptical people to finally get vaccinated, and this coul a

let's begin with the big news today, with the fda finally approving the pfizer vaccine. does that really open doors for mandates across the state now? >> not only across the states, but i'm thinking that this will lead to a seachange globally as well. a lot of countries actually look up to the u.s. fda in terms of guidance. >> now let's talk about this new cbs news poll that finds that 69% of parents concerned their children will get covid in school, many schools now fully opened in person learning. cases among kids 12 to 17 up almost 1400% since june. what can fully vaccinated parents do to protect ei

the fda giving full approval now to the pfizer vaccine and what this could mean for vaccine mandates in this country. and the news coming in from afghanistan tonight. the evacuations. how many americans, how many afghan interpreters remain? and will the president extend that august 31st deadline? tonight, the taliban with a warning if he does. >>> first, the coronavirus and tonight, pfizer now the first covid vaccine in the u.s. to be fully approved for americans 16 and older. until now, it had been given emergency use authorization, now full approval. found to be 91% effective at preventing the virus. federal authorities have long hoped this moment would help with the unvaccinated, providing additional proof of the vaccine's safety. what this could mean for vaccine mandates moving forward. what new york city has done. and companies, too. the united airlines tonight giving employees five weeks from today to be fully vaccinated. and all of this comes as more than 180,000 children get covid in just one week. dr. jha standing by, answering questions on all of this and the booster and wh

governor newsome responding to the fda's announcement today saying, quote, the fda's full approval further confirms that the pfizer vaccine meet a rigorous scientific standard for safety and efficacy. >> protecting against serious illness hospitalization and death with covid-19 cases rising across the nation due to the delta variant. i encourage all californians to trust the science and protect themselves and their community by getting vaccinated. a boost of confidence for booster shots. recent studies showing now a 3rd dose of pfizer's covid vaccine significantly improves protection again. serious illness, especially in people over the age of 60 people are 4 times less likely to catch covid after 10 days compared to having just 2 doses of the vaccine and for your health tonight, you're more likely to spread covid if you're showing symptoms. that is according to a study from the university of georgia. >> researchers found a 30% increase in transmission for symptomatic patients. the study also found symptomatic people increase the chance of others becoming symptomatic themselves. the city o

pfizer today granted full fda approval for its vaccine. the hope now is that americans who have been waiting for a full fda sign-off will have the reason they need to roll up their sleeves. but the news is also strengthening the hands of companies and institutions that are moving to require workers and students in some cases to be fully vaccinated americans still playing catchup with a virus that infected 180,000 people just this past weekend and took almost 1,200 lives. miguel almaguer has details. >> reporter: expected but still historic today's full approval of pfizer's vaccine for people 16 and older marks another major milestone in the pandemic, coming 97 days after the fda began its official review the first covid vaccine to move beyond emergency use authorization. the new announcement expected to move the needle on future vaccinations >> those who have been waiting for full approval should go get your shot now. the vaccination is free it's easy, it's safe, and it's effective >> you're going to feel a little pinch, okay >> reporter:

the fda is prioritizing the evaluation of covid-19 vaccines. this is the top priority for the fda. but in order for the fda to evaluate a vaccine for under 12s, it has to get an application first from the companies, which means they have to complete their trials, put the data together, and submit them to the fda. the trials are still underway right now for kids under 12. and my hope is that they will come to a conclusion soon and that we will get that application from the companies to the fda because i will tell you that they will move fast to evaluate that, to determine, again, if a vaccine is safe and effective tomorrow for our kids. if everything were to go well, i think it's possible that we could see a vaccine before the end of the calendar year for kids under 12. but, you know, everything would have to go well in that circumstance. but make no mistake, the fda will move quickly on this because they recognize what's at stake. it's the health of our children. and there's really nothing more important than that. >> you're absolutely 100% right. as you know, president biden is lo

senior team and the whole staff at fda, especially during the pandemic. fda has strong leadership and their critical work continues as we continue to get safe and effective vaccines to the american people. the booster decision which you referenced, that decision was made by and announced by the nation's leading public health officials including dr. wolinsky, dr. fauci, dr. murphy, dr. collins, and others. as our medical experts laid out, having reviewed all the available data, it is in their clinical judgment it is time to prepare americans for a booster shot. we announced our approach in order to stay ahead of the virus and give states and pharmacies time to plan. and to be transparent with the american people as to the latest data and expert clinical judgments from the team, to give them time to do their own planning. . we have been very clear throughout that this is pending fda conducting an independent evaluation and cdc's outside experts. the bottom line, this virus has proven to be unpredictable and we want to stay ahead of it and plan for every sce

the fda approval is the gold standard and as i just said, now, it has been granted. today's announcement from the fda makes the pfizer vaccine the first in the united states to move beyond the emergency. you status and gained full approval good evening, everyone i'm frank somerville and i'm heather holmes in tonight for julie president biden called the approval a sign of the overall progress being made against the pandemic as ktvu rob roth reports tonight. the president hopes that it will make way for more vaccinations. today. uh we've hit another milestone that milestone came with the announcement monday that the food and drug administration for the first time is granted full approval to fighters covid vaccine for those 16 years of age and older prior to that, the fda is given the vaccine emergency use status the fda approval is the gold standard, and as i just said, now, it has been granted fda officials said in a briefing that while the review is relatively fast, it was also. thorough their efforts to move as quickly as possible have in no way sacrifice scientific

the fda tweeting you're not a horse. you're knot a cow. seriously, y'all, stop it. you're not a horse. you're not a cow. seriously, y'all, stop it. so let me get this straight. think about this, okay? you won't get vaccinated. you won't wear a mask. you said you're worried about the fda approval you don't know what's in the vaccine but you'll take a drug meant for deworming livestock? really? you'll trust your health and life to rumors and misinformation? just the latest in the hall of shame of covid misinformation. >> supposing you bright the light inside the body, which you can do through the skin or in some other way and i think you said you're going to test that, too. sounds interesting. then i see the disinfectaing where it knocks it out in a minute. is there a way to do something like that by injection inside or almost a cleaning because you see it gets in the lungs. >> the former covid misinformation in chief right there. but even he can't control the misinformation anymore because this weekend he told a crowd of supporters in alabama to get vaccinated and gu

. >> reporter: pfizer's covid vaccine is the first to be given fda approval. it is 91% effective in preventing disease. many predict the approval will be enough to convince holdouts to finally get the shot. >> at the individual level we know from the kaiser family foundation that one third of the unvaccinated folks may be more willing to get a vaccine if it's fda approved fully. >> reporter: public health experts say the fda's decision has more wide-ranging implications as the state struggles with a surge in covid cases driven by the more-infectious delta variant. >> it will lead to more mandates among employers, governments and schools, and that will have a much bigger effect. >> reporter: the pentagon is already saying it will require the vaccine for more than a million service members starting next month. >> we're going to move forward making that vaccine mandatory. we're preparing the guidance to the force right now. >> reporter: there's another possible impact. >> it does lead to off-label potential use by clinicians across the country, now that it has fu

. >> fda approval. do you believe this could be something that creates a massive catalyst among people who haven't been vaccinated to date? >> chris, it's a really important day in our fight against covid-19. i don't know about the word "massive," chris, but i certainly hope for those who have been waiting for this full approval that this is the impetus for them to get vaccinated. we have clear evidence of the safety and effectiveness of the pfizer/biontech vaccine. it's undergone full approval and full vetting by the gold standard, the u.s. fda. >> you used full there twice. the hate parade is already marching and saying they took shortcuts. this isn't real approval. they hedged it just to make you take it. do you believe any of that? >> no, i don't, chris. we heard from the fda today that the application for the pfizer/biontech, biological application license for full approval was over 300,000 pages. the fda career staff went through it, they did the number crunching, they know. so not only was this d

this is a clinical judgment and there is no way the cdc or the fda or dr. fauci are going to be able to specifically define that term when it comes to making the decision do i give this patient a dose, a third dose or not? and unfortunately, this is the reality in clinical medicine. it's like when do you go to the next step? it's not clear. the other thing of course, i wish we were getting a lot more caveats about this is what we know today and may not be what we know next week. so there is a lot of variables here that are influx, in play constantly in this whole debate. chuck? >> all right. i'm going to personalize it. is age a line here for you? would it be everybody over the age of 75? you know, at some point, the age of somebody makes you automatically -- your immune system is a bit more compromised. what is that definition? is it really the definition of if you feel vulnerable, get the shot? >> no, it's really going to be more about does your doctor, your personal physician think that whatever conditions you have and your age, do they in total make you

to get this vaccine by the fda. so what president biden said today was kind of in line with the cdc guidance of what they had issued about kids going back to school, saying that make sure everyone you can around your child who isn't vaccinated and can't be vaccinated is vaccinated. that means parents and other teenagers who are eligible to get the vaccine. and he said make sure your kid is wearing a mask when they leave the house. >> all right, kaitlan collins, thanks so much. >>> meanwhile, covid cases and hospitalizations continue to rise. in florida the number of people dying from covid every day is at its highest point of the entire pandemic. and as cnn's nick watt reports, more local officials all over the country especially in florida are denying governors' block on mask mandates. >> reporter: the pfizer vaccine now fully approved for people 16 and over. >> this is a pivotal moment for our country in the fight against the pandemic. the public can be confident that this vaccine meets the fda's gold standard for

prior to that the fda has given the vaccine emergency use status the fda approval is the gold standard and as i just said, now it has been granted fda officials said in a briefing that while the review was relatively fast it was also thorough. their efforts to move as quickly as possible have in no way sacrifice. scientific standards or the integrity of our process, president joe biden said he hopes the fda approval will help give confidence those who are hesitant about getting the vaccine the kaiser family foundation released a survey that found about a third of the unvaccinated say they would be more likely to get vaccinated with full fda approval those have been waiting for full approval should go get your shot now vaccinations free. it's easy it's safe, and it's effective. but president and biden also had an appeal to employers to make vaccines mandatory for their workers. if your business leader a nonprofit leader, state or local labor, who has been waiting for full fda approval to require vaccinations i calling you now to do that you csf infectious disease specialist dr peter jin

yet with the fda approval of the pfizer vaccine, dr. fauci suggested he thought 20 million or so might now get it. what is your sense of that how this official fda approval may change the trajectory here? >> reporter: i think a lot of us thought that would be sort of what pushes it over the top. certainly the doctors told me they believe this is a game changer. but the kaiser family foundation did a study before the approval by the fda asking those who were hesitant and it was about 7 in 10 said they won't get vaccinated even with the approval. 3 in 10 will get vaccinated. that's a significant number of people. in fact, i met a woman, amanda, who decided, even though she has heard now that it is approved, that it's just not for her. on top of this, her uncle is right now in the icu, a doctor held up a phone and her uncle pleaded with her to get the vaccine. and even as he's there dealing with coronavirus, in the icu, listening to the video, well, listen to what she had to say. >> you have those close to you that have coronavirus. >> rig

fda for pfizer's vaccine. we are standing by waiting for that. the news continues next with alisyn and victor. stay with us. and there you have it- woah. wireless on the most reliable network nationwide. wow. -big deal! ...we get unlimited for just 30 bucks. sweet, i get that too and mine has 5g included. that's cool, but ours save us serious clam-aroonies. relax people, my wireless is crushing it. that's because you all have xfinity mobile with your internet. it's wireless so good, it keeps one upping itself. ♪ ayy, ayy, ayy ♪ ♪ yeah, we fancy like applebee's on a date night ♪ ♪ got that bourbon street steak with the oreo shake ♪ ♪ get some whipped cream on the top too ♪ >>> today -- >> here is president biden speaking on vaccines. let's listen in. >> in our nation's fight against covid. food and drug administration, the fda, announced it has fully concluded its now thorough independent scientific review after a strict process, the fda has reaffirmed its findings that the pfizer covid-19 vacci

would that be a deadline when the fda comes out? >> yes, yes. >> reporter: and universities like louisiana state have said they would mandate the vaccine quickly after authorization. some public health officials have said they were surprised it has taken so long for full approval. white house officials have maintained they will not put pressure on the agency. >> the fda is the gold standard for vaccine review and approval they'll run independent and rigorous scientific process. when that process is complete, the american people can rest assured that the fda maintained this world class standards throughout this period. >> reporter: but for some, it stale may not be enough. >> the pfizer shot is about to get full fda approval. would that change your opinion on it at all? >> not until they do a whole lot more investigating on that. >> reporter: that woman went on to say it would probably take ten years to do the investigating to get her to take the vaccine. cheerily look, not everyone will be convinced. some administration officials he

>> i think some people will get vaccinated as a result of the fda approval. but i think what really is going to get people vaccinated are -- are consequences. sticks, at this point, if you will. when employers tell people, you know what? if you want to step foot in this office, you better have a vaccination. if you want to be able to go to the football game, you bitter h better have a vaccination. i mean, this is what is going to get people vaccinated. you have to impose consequences on people for their reckless behavior. some people don't get vaccinated because their dogmatic. some because they're -- >> so, let me -- let me ask you this. i said that and i have heard others say that. and people say, oh, commy and this is, you know, america and we don't do that here, in america. where -- what do you say to that? >> well, i -- i had to get my kids vaccinated to go to school, last i checked. you know, it's been a while for me. and we have all gotten vaccinations. we put our arms out and i say to all of them, you know, in this country. you know, we -- we are very

as the first fda-approved covid-19 vaccine, the public can be confident that this vaccine meets the fda's gold standards for safety, effectiveness, and manufacturing quality that we require for an approved product. >> words that could not come a day too soon. that is because, as of this weekend, the country's back to averaging a thousand-plus deaths a day from covid. that grim figure hasn't been this high since march. in florida, over the weekend, hospitalizations set a new record for the entire pandemic with more than 17,000 men, women, and children in covid units, icus, and ers across the state. nationally, new cases are, once again, averaging close to 150,000 a day. that's nearly ten-times what they were in june and experts on this program have predicted they'll hit 200,000 a day before this latest surge is over. even as cases soar, vaccine hesitancy or even outright hostility remains. and while today's announcement might not persuade the hardest-core vaccine refusers, recent polling from the kaiser family foundation suggests one in three unvaccinated americans would be more likely to

first, in 2017 from a former fda commissioner scott testified before the committee and set fda approves expanded access to 90% of time and wanted to know two questions. so, why did i still have difficulty accessing trucks under the program? what recent manufacturers have for declining to participate expanded access. >> thank you for that question. i confirmed that we are still approving the overwhelming majority of expanded access application in between the past five years we have approved 8%. there are reasons for companies not making the investigation of drugs available through expanded access. the first one is the fact that there might be clinical trials and the patient's who are asking for expanded access for that clinical trial. make the concerns about slowing down recruitment of the clinical trial docket provide important aspects on the drug. for small companies what we have also seen as they may be financial constraints in supporting an expanded access program sometimes we see some issues with limitations in the drug supply drug supplies for an ongoing clinical trial. oregon and

vaccine is safe and effective and the fda has given the full and final approval. so let me say this loudly and clearly. if you have and if you are one of the millions of americans who said that they will not get the shot until it has full and final approval of the fda, it has now happened. the moment that you have been waiting for is here. it is time for you to go get your vaccination, and get it today. today. it an important moment in the fight against the pandemic. you know, i want to thank the acting commissioner janet woodcock and the entire team at fda for the work. janet woodcock is a true scientist and serving under the democratic presidents and republican presidents. she has ensured that the team follow the science above all, and looked at the mountains of clinical trial data and the safety and the efficiency day and concluded without question that the vaccine was safe and effective for emergency use in december. that same thing that we have those shots in the arms at the time, and 350 million in the united states, and billions across the world. they kept

fda had to put something on that. now we're having to have people put out statements please don't take your cow's dewormin' medicine. >> we can check that off. >> the at the same time people that are taking their cow's dewormin' medicine, they are not taking a vaccine that nearly 200 million americans have already taken. a vaccine that science shows, medicine shows will actually significantly cut the likelihood of you getting covid and getting bad side effects from covid down to like .005. more of a chance to get struck by lightning. more of a chance to die from a tree falling on you than actually about having a negative side effect, serious negative side effect from this vaccine. now please, go ahead, take the horse dewormin' the. no, don't do that. what's wrong with you? can you show us the fda plea again that looks like it's straight out of the onion. this pretty much tells you where we are in 2021 where we have people who are dying, loved ones are watching dying, who aren't taking the vaccine, people who are -- we

pfizer gets full fda approval in the race to fight the coronavirus. how some companies are wasting no time with new vaccine mandates. >>> drawing a red line. the taliban warning if the u.s. keeps soldiers past tuesday's deadline. >>> midnight ceremonies. a new chapter begins for new york state with its first ever female governor. >>> good morning. good to be with you. i'm anne-marie green. more americans are now facing vaccine requirements less than 24 hours after the fda granted full approval of the pfizer covid vaccine. within hours of yesterday's decision the pentagon, retailer cvs and the new york city school system among others announced they will require employees to get shots. president biden called on more companies to step up vaccine mandates. elise preston has the latest from new york. good morning. >> reporter: good morning, anne-marie. in addition to the mandates, the hope is americans will feel more eased to get the shots. pfizer's covid vaccine is fully approved for americans 16 and older. >> this approval now furthers our confidence tha

the fda formally approves pfizer's covid-19 vaccine. but will it change minds and what will that mean for vaccine mandates. thank you for joining us here on kron, 4 news at 10. i'm pam moore and i'm ken wayne, an important milestone in the fight against coronavirus in a summer surge fueled by the dangerous delta variant the fda today formally approving pfizer's covid vaccine our grant lotus standing by here in the studio tonight with the latest details grant pam ken, the 2 dose pfizer shot was of course, first authorized for emergency use. that was back in december for people 16 in up now. 12 and up can get it. and since then, it has been administered and. >> something of an experimental phase, but that all changed today, full fda approval carries the agency, strongest endorsement of a product that we have that now. and this comes after more than 188 million doses of the vaccine have been administered. so far in the u.s. in the fda had a lot of data to work with when determining just how safe the vaccine is the agency inspected. the com

pfizer's covid-19 vaccine now has full fda approval previously the fda had only granted emergency use authorization of that vaccine. that means the vaccine is no longer considered as being an experimental phase and local infectious disease. experts say the approval will likely lead to a slew of vaccine mandates outdoors. dan kerman has been talking to medical experts about all this and he joins us live from ucsf with more. dan. well, we've seen lots of places throughout the bay area and california already put in these mandates governments as well as universities. it's not the case necessarily all the way across the country. >> many corporations and businesses and universities waiting for this infectious disease. experts say now they say they will go ahead and put forth that mandate like we're seeing here. the fda's full approval of the pfizer covid-19 vaccine. >> could lead to a dramatic increase in the number of people vaccinated. >> businesses and institutions in the united states. a lot of them have been waiting for this approval before mandating vaccination. so i think we're going

and that's going to be an fda decision. it is entirely conceivable that they will judge, given the situation that we're seeing so many infections in children, and children going to the hospital, they may say that you can get it under an emergency or they may say given the safety concerns, not that there's any overly concerns, but given the safety precautions, they might want to wait a few more months. and again, we leave it up to them because that's a regulatory decision that when you're dealing with children, it's fundamentally based on safety. i don't think there's going to be any question that this is going to be effective in the children at that younger age. i have no doubt about that. it's going to be a safety issue. >> so you're talking really in the new year, you know, if it's october for the companies to get their data together, you said a little later for pfizer. >> no, a little later for moderna. >> for moderna, i'm sorry. so you're talking really it's unlikely we'll hear even if it's an emergency use authorizatio

to satisfy the fda moderna is expected to get its full fda approval in a few weeks at johnson and johnson before the end of the year. rob roth ktvu fox two news. the pentagon says is preparing to make the vaccine mandatory for the u s. military officials say it's an effort to ensure the health and safety of troops who often live in close quarters the defense department says guidance of the vaccines being developed and a timeline will be announced in the coming dares right now, the pentagon says about one million out of 1.4 million active duty military are fully vaccinated with the visor vaccine receiving fda approval today. the clock is now ticking for san francisco city workers to get their shots or lose their jobs as katie's christien kafton reports tonight this is part of the policy that the city announced back in june requiring all city workers to be vaccinated in just a matter of months. all city workers in san francisco will be vaccinated or risk losing their jobs the city announced in late june it would require all city workers to be vaccinated 10 weeks after the food and drug admi

the breaking news of the morning, the fda approved pfizer's covid vaccine. prior to that new york city is mandating vaccine shots for all public school teachers and all school staff. that is new york city. the time is up for me. neil, it is yours. neil: thank you, stuart, very much for that. that by the way many of the factors living the corner of wall and broad. particularly helping cruise line stocks, leisure stocks, airline stocks, drug stocks, you name it. nasdaq, s&p at record territory. not all that far away. we'll keep an eye on that, that despite maybe because of what is going on in afghanistan because things appear to be stablizing, at least in the market's eyes, not getting any worse. that is really in the eye of the beholder. there is vision among ranks of those who have people, britain, germany, and the united states all arguing about having to get on the same page but far from that, again the indication is the administration would love to have this all wrapped up by the end of this month, august 31st there is sort of decree by the taliban that t

but the way to solve this is to get it fda approved. i would say, and i urge president biden, the fda is a faceless bureaucracy to most people right now. it's really critical that he nominate a person of his choice, and have the senate confirm that person, so the american people know in a bipartisan way, we believe in the fda director. that commissioner could have le leadership and be the face of this. that's very important. we shouldn't overlook that. >> we have to get new numbers. the wave of people getting vaccinated for the first time is a good thing. but it may change our metrics in terms of how people feel. as of the last count a few weeks ago, over 50% said, if it were fda approved, i would feel differently. i have a question for you. this may be too in the weeds, so help me with it. the cdc puts out the mask change, people lie and say it's about the india study, but it was about what they saw on cape cod. they don't put out any adjoining data as to why they were worried. and then may 1st, the cdc put out that we're not counting

and also, how much data is the fda actually waiting for? the urgency to get the vaccines for younger children is quite extraordinary, now. i mean, right now, we're entering a period that is, arguably, the most dangerous time for children during the entire pandemic because we have the delta variant. we have 93,000 children, who are getting -- who have gotten infected in the last week. more than 200 kids are getting hospitalized, every day. and now, kids are going back to school. people are not using the same precautions, as they were before. and so, i think we need to raise the level of urgency and to really ask the question, how much data are we looking for? i mean, how many children need to be in these studies? what is the level of safety and the time period that we need? definitely, we want to make sure these vaccines are safe and effective. of course. we don't want any -- any corners to be cut. but we also need these vaccines pretty urgently, too. >> yeah. dr. leana wen, thank you. sanjay, appreciate it, as always. thank you. >>> coming

the fda grants full approval to pfizer's covid shot. and that clears the path for more vaccine mandates. but before we go to break, we want to know why are you awake? e-mail your reasons to way too early at msnbc.com or you can tweet me at kathy k underscore using the hashtag way too early and we will read our favorite answers late on in the show. on. you love your pet...but hate wearing their hair. did you know that your clothes can actually attract pet hair? with bounce pet hair & lint guard, your clothes can repel pet hair. one bounce mega sheet has 3x the hair fighting ingredients of the leading dryer sheet. simply toss into the dryer to bounce out hair & lint. look how the shirt on the left attracts pet hair like a magnet! pet hair is no match for bounce. it's available in fresh scent & unscented. with bounce, you can love your pets, and lint roll less. (vo) unconventional thinking means we see things differently, so you can focus on what matters most. that's how we've become the leader in 5g. #1 in customer satisfaction. and a par

telemundo mediodía la administración de alimentos y medicamentos (fda) aprueba la vacuna contra el coronavirus de pfizer hasta ahora para uso de emergencia solamente la pueden recibir mayores de 16 años, en tennessee siguen buscando a desaparecidos después de las lluvias caídas en minutos durante el fin de semana hay 22 desaparecidos y destrucciones en viviendas y vehículos, henri es una depresión tropical pero va a dejar lluvias en su desplazamiento al este new york sufrió su paso con inundaciones >>> no tenemos quién nos ayude con la enfermedad del covid-19 >>> miles de damnificados en méxico después del paso del huracán grace se sienten abandonados por el gobierno de andrés manuel lópez obrador 16 estados fueron alcanzados por el huracán que deja 8 muertos >>> (habla en inglÉs) >>> marca su jonrón 500 miguel cabrera de detroit y entra a un club con otros 27 jugadores lo hizo ante toronto blue jays (♪ música ♪) (♪ música ♪) >>> hola qué tal les saluda nicole suárez feliz inicio de semana es un hecho la aprobaci de la vacuna de pfizer para mayores de 16 años para d

the full fda approval of pfizer's covid vaccine for anyone 16 and older. local experts say that it could persuade more people to finally get a shot. it could also lead to more mandates across the state. full approval opens the door for more companies requiring workers to be vaccinated. >> be? about these vaccines was can you mandate the vaccine in any way. fda approval removes that question and puts workplace met vaccine mandates on very strong legal footing. >> moderna has also applied to the fda for full approval of its vaccine. johnson and johnson says that it hopes to do so later this year. >>> across california, more than 46 million doses of the vaccine have been administered, and in the past day the state recorded more than 10,000 new covid cases and three deaths. positivity rate has dropped again to 5.4%. >>> let's take a live look at san jose, where thousands of city employees are now facing some strict covid mandates. starting today they must show proof that they are vaccinated or get tested weekly. if they don't they could be fired. kpix 5's len

: fda approval also paves the way for more vaccine mandates. almost immediately after the announcement, president biden made the shot mandatory for active duty troops. new york city issued a mandate for school employees without the option for weekly testing instead. meanwhile, pfizer's ceo says the company is developing a vaccine that targets the delta variant, but he said he does not think it will be needed because the current vaccine is so effective. dan lieberman, abc news, new york. >> dan, thank you. >>> a spike in covid cases has prompted hawaii's governor to urge visitors to stay away. limited hospital space led the governor to say this is not a good time to travel to the islands. the city of honolulu is suspending all large gatherings for next month. >>> president biden has approved a disaster declaration for tennessee after that deadly flood west of nashville. the search will resume today for 10 people missing, 21 others confirmed dead. survivors are describing how they escaped a wall of water which destroyed entire neighborhoods after

vianey is tracking some relief. >>> full approval from the fda as soon as monday. the big announcement from pfizer could change vaccine hesitant minds. i'm morgan, and there's more to me than hiv. more love, more adventure, more community. but with my hiv treatment, there's not more medicines in my pill. i talked to my doctor and switched to fewer medicines with dovato. dovato is for some adults who are starting hiv-1 treatment or replacing their current hiv-1 regimen. with just 2 medicines in 1 pill, dovato is as effective as a 3-drug regimen... to help you reach and stay undetectable. research shows people who take hiv treatment as prescribed and get to and stay undetectable can no longer transmit hiv through sex. don't take dovato if you're allergic to its ingredients or if you take dofetilide. taking dovato with dofetilide can cause serious or life-threatening side effects. hepatitis b can become harder to treat while on dovato. don't stop dovato without talking to your doctor, as your hepatitis b may worsen or become life-threatening. serious or life-threateni

is the cdc getting ahead of the fda on this? and i think that's what's causing some of this frustration at the fda. >> yeah. well, i mean, the fda, they're scientists and doctors and the other people are politicians. >> right. and they need to look at data. they got to make the case. this isn't just about, hey, these shots should go to other places in the world. do we need them? that's going to be the question they really need to answer. >> a new study estimates that masking and testing in schools could help prevent covid infections, masking and testing. what does the science say? >> so this is looking at all the observational studies and all the modeling studies that you and i talked about last week. and they basically are saying when we put this all together, what is the modeling show? they say about 75% of students will be exposed to this virus and get these infections. so that's really significant obviously concerning. if you start to layer in these strategies, that's when they say that 24 to 50% with universal masking will

the fda had only granted emergency use authorization for the vaccine. the change means to the vaccine is no longer considered being an experimental or in an experimental phase and local infectious disease. experts say that the approval will likely lead to a slew of vaccine mandate. referees dan kerman spoke to medical experts today and has details. the fda's full approval of the pfizer covid-19 vaccine could lead to a dramatic increase in the number of people vaccinated. >> businesses and institutions in the united states. a lot of them have been waiting for this approval before mandating vaccination. so i think we're going to see a lot more institutions like universities. governmental and private enterprise. now mandating vaccination u c berkeley infectious disease specialist doctor john swartzberg says. >> it may also convince individuals on the fence to push ahead on their own. a lot of people who said i really genuinely want to see what the fda has to say where the real stamp of approval. >> and i think they're going to get vaccinated and that will

this is the first coronavirus vaccine given full approval by the fda. to this point, remember, it's been under what's known as emergency use authorization, still safe, and many millions of people have been vaccinated. however, big changes expected with this, include ing opening e door to more vaccine mandates. cnn's elizabeth cohen joins us now. i mean, in the scheme of things, this is pretty remarkable speed to get to full approval for a vaccine such as this. >> it is remarkable. they just started the clinical trials about 13 months ago. i mean, that is really amazing. people were talking, oh, it will take four or five years. they went from 13 months from starting the trial to full approval. that is really quite amazing. now, unfortunately, about a third of the united states hasn't seen it as amazing as this sort of medical miracle that we were given. some people see it as, wait a minute, that's a little too fast for my taste. i don't care that more than 40,000 people were involved in the clinical trial and that it was declared safe and effective. i wa