one urge fda to approve am x today. urge fda to approve neuron for the sub-35 group today. and three, pass act for als which funds expanded access today. four, pass the promising pathways act to provide a conditional approval pathway for rapidly progressing fatal diseases beyond als. i beg of you, there are tens of thousands of patients watching this from their homes, and wheelchairbound and watching this today, and many are postponed their suicide waiting for this hearing, and i don't think that you understand what this hearing means for us, and please do not let another generation of als patients die in pursuit of the perfect. please, let this be the first generation to survive. >> we want to live. you have the power to make that possible. >> we want to live. you have the power to make that possible. thank you, chairwoman. >> i think that there is a sound building across the country of an applause of the als community listening to you offer your message to this committee. we are so in debt to you. we thank you for your clarity. we thank you for your courage. thank you for

hopefully from the fda this afternoon. dr. anthony fauci will be joining us to talk about the advisory meeting at the fda on boosters plus, senator marsha blackburn's team is talking with the facebook mwhistleblower behind that bombshell facebook report about instagram and facebook's impact on young jusers. senator blackburn will be with us to talk about her new probe into the company and what congress can do about it >>> first, mike tracki ing all h market action. meg terrell has the latest on that fda manual meeting on boosters what are you watching with all 11 sectors lower right now heading into the close >> this is a downside test in the market that to a degree, a lot of people have been looking for. the s&p 500 has been choppy with the downside bias for the last two weeks, since september 2nd today, we did cut below, just by a little bit right now, the 50-day average that's about the seventh time this year that we actually have hit or gone slightly below the 50-day average that's been an occasion for these dip buy opport

the fda also plays a key role. the agency is responsible for the safety and efficacy of all drugs and treatments in development, including those to treat brain disorders. fda also provides guidance to industry on clinical trial design, meaningful end point considerations to determine whether a treatment is beneficial and market approval. it also works with physicians and patients when treatment options may be unavailable. through both the 21st century cures and the fda reauthorization act, this committee has encouraged greater guidance on the use of novel clinical trials and the inclusion of patients in the drug development process. these are all promising steps but it's clear that a lot more must be done to support the discovery and development of safe and effective treatments and cures and to provide quality, affordable and equitable care to patients and their families. in order to protect patients, caretakers and the american public it's important that we understand the current state of science for neurodegenera

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

the fda focuses on that pretty well. but are you doing that -- but are you also focusing on efficacy to such an extent that you can't really standardize it? something like stem cell therapy, which is very clearly safe, is the fda getting in the way of it, trying to standardize the efficacy of it in a very unreasonable way? is it worth looking at a paradigm shift on that? >> when it comes to unmet medical needs, we take an approach where we want to be as flexible as possible. understanding that there is a higher tolerance for safety. and we also -- like the situation when we use accelerated approval, for instance, we also accept when, in the appropriate instances, the fact that there may be some residual uncertainty about efficacy. this is actually an inherent element of the accelerated approval pathway, which we have used in many situations. and for unmet medical needs. for example, infectious diseases. >> okay. thank you. i yield back. >> gentleman yields back. the chair is pleased to recognize the gentlewoman from wash

is the winner's job or the fda. there any thousand that subject. >> i will jump into answer that, i don't know i do think that from the beginning that the message to these borrowers was if you use it the right way, you will be forgiven and i think that is the message that so many of us heard as borrowers. and i think independence, were happy to review that message when it does happen. we are happy to do this and in basically for the employee training to our borrowers so that they understand. to understand that they have going forward with that. >> with that i yield back. and i think you all again for being with us today.>> >> now we recognize the gentleman from new york. >> thank you for having this hearing and thank you to the witnesses as well and we appreciate your testimony so far rated i want to start with mr. fisher, because he sort of a follow-up to vote you were talking about and how you've been dealing with the customers looking for forgiveness. in the processing application and whatnot read have you come a

are you at the fda aware of any efforts from the fda to utilize the data at the registry. >> i can't think of any instances right now. this is something i would be happy to get back to you after the hearing. >> i would appreciate that very much. i'll just underscore, brought up by mr. butterfield and chairman upton, that one of the most substantive victories achieved in my time in congress was the passing of the 21st century cures act. it did provide hope for so many families who had been suffering from a long, life altering illness. i want to point out during the work on the cures, i felt fortunate to include a stand-alone bill to establish a national neurologic conditional surveillance system. prior to us passing the cures act there was no official structure in place to provide surveillance of neurologic diseases. i'm grateful that's been established. now we need to take the next step. we need to utilize that information and deliver the benefits for our patients. thank you, madam chair. i'll yield back. >> the gentleman yields back. the chair is pleased to recognize the gentlewoman

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

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

hands of the fda. they described the plan that they're going to use to analyze those data and make sure that these vaccines are both safe and effective for kids. what we heard is it's likely that if the data are as expected that the authorization, the emergency use authorization for kids will come as early as halloween. i know that's what my kids want which is a candy bar and a shot, but it may come a little bit later into thanksgiving, but we're going to get this done hopefully in the next few months. what i'm focusing on now is turning to the cdc to make sure they have a plan to actually deliver the vaccines. vaccines don't save lives, chris. vaccinations save lives. we have to actually get the shots into arms and that means the cdc needs to have a plan to do that. >> so is what you're saying right now with the boosters, does this inspire to say to them you need a better process. i don't want to hear from the fda and the cdc, you have to do better and come up with one set of recommendations. >> that'

the fda leaving the door open for the potential to add other groups incrementally. but up first, 65 and older, suggesting you get the booster six months after that second dose. and on the larger question of boosters for everyone 16 and older, they voted no, saying more data is still needed. of course all of this goes to the cdc next. dr. jha standing by tonight. what likely happens from here, and where to get that booster. and what if you had the moderna or johnson & johnson vaccine? i'll ask the doctor. >>> also, the pentagon admitting the deadly drone strike in the final days of the u.s. withdrawal from kabul was a, quote, tragic mistake. ten civilians, including seven children, were killed in the blast. martha raddatz reporting tonight. also, the chairman of the joint chiefs, general mark milley, and his first public comments about his communications with china in the final days of the trump presidency. what the general said today. >>> tonight in the nation's capital the fencing and the warning. authorities now warning of threats of violence and of concerning cha

the fda reauthorization act of 2017 required fda to hold a public meeting on clinical trial inclusion and exclusion criteria, which was held on april 16, 2018. a report was issued shortly thereafter. putting these inclusion and exclusion guidance measures together in a comprehensive way can present unique challenges, as you know. researchers have to evaluate populations with different phases of disease progression, which is complicated, and determine how to maximize the clinical benefit brought to bear at each stage. as fda noted in its report, there's a tension between balancing the desire to minimize statistical noise, which can mask a finding of the affect for certain populations. on the one hand. and then the desire to generate data that can be applied to a wide patient population on the other hand. doctor, can you summarize why this tension exists and what developers in your view should consider in order to balance the tension, especially when it comes to neurodegenerative diseases which we are discussing today? >> thank you for the question. i acknowledge the fact that there is

the fda says not a good idea. voting against recommending a covid booster for people who are 16 years or older. but it's not quite that simple. owing to the confusion about what the medical community thinks, they're having a revote an a reframed question, which most of the medical community seems to think would allow or be open to those with extenuating circumstances or compromised immune systems of the elderly to get this booster shot. it's big news right now on top of the tragic news about the devastating drone strike that claimed so many lives. i want to bring you up to date on this fda development. welcome. i'm neil cavuto. this is "your world." it was the president's push to make sure that those even already vaccinated get an insurance shots, a booster shot, a third shot that will protect them. the companies behind making these boosters and the only one that's been cleared is pfizer. moderna is working on one that could get approval very soon. the rub is that it might not offer the great benefits that either

late today, the fda now weighing in. >>> also tonight, parts of the u.s. now bracing for up to 20 inches of rain with a major tropical storm that could become a hurricane, slamming into the u.s. authorities now warning of life-threatening flooding tonight. ginger zee in texas with the timing and the track affecting several states ahead. >>> tonight, the arrest in washington, d.c. an armed suspect outside dnc headquarters. the suspect's truck painted with nazi symbols. capitol police allegedly finding a machete and a bayon net inside. and the arrest coming just as the fencing goes back up around the capital, ahead of a rally supporting the septembers in the janua january 6th attack. >>> tonight, secretary of state antony blinken defending the operation in afghanistan, saying, quote, we inherited a deadline, we did not inherit a plan. >>> will california's governor survive a recall on the eve of the high stakes recall election there? president biden campaigning for governor gavin newsom in these final hours. the leading republican candidate, conservative rad

psaki: it was the fda acting head who endorsed boosters. reporter: the point is the fda itself -- [indiscernible] the question is does the administration have any concerns coming out and recommending was to shots before they are recommended by the fda, that might be seen as unduly influencing. ms. psaki: no. it is the acting fda head and eight of our health and medical experts from agencies, not the white house who put out this statement making this recommendation because they believe you need to come forward and we support with data when it is available and make that available to the american people. make sure the american people understand and know that there could be a winning efficacy of these vaccines and that is where they recommend it. imagine if they had not come out and shared that was their view and this is where it might be headed. it needs to go through a process. they have said that in every single statement they have made publicly. we believe the american people are smart and they are paying attention and they would want to kn

tonight, the fda now releasing the numbers on pfizer. and news on moderna, too. >>> first, that gut-wrenching testimony from some of america's top athletes. olympic gymnasts simone biles and aly raisman among the athletes testifying before congress, saying they were betrayed by fbi agents. they say they buried their sexual abuse allegations against former team doctor larry nassar, allowing for more than 100 additional victims. tonight, fbi director chris wray and you will hear his apology to the gymnasts. rachel scott live on the hill. >>> also tonight, the fda releasing pfizer's data on its booster shot trials. and tonight, pfizer now recommending a third shot for those 16 and older. about six months after receiving your second dose. tonight, you'll see what their data shows. how much does the vaccine wane over time? moderna releasing its findings on a booster shot, too. so how would this work, if you got pfizer, a full shot for a booster, if you got moderna, a half shot. dr. jha is here tonight answering your questions on the likely pa

the data submitted by pfizer to fda for kids 5-11 is supposed to arrive in fda's hands later this month. i know they will work 24/7 to go through it and try to assess whether it's time to grant an approval and that will happen in weeks, not months. giving a precise date, i don't think that will be a smart idea. it will be coming certainly and i know many parents are worried about that. i'm glad we're talking about this as well. the best way to protect those kids right now is to have the people around them vaccinated so, chris, before we left off, before we leave off here, could we appeal to those 75 million unvaccinated people who have not gotten their first dose, i know you've been very positive about the need for that. let's not miss the chance, one more time, to say that's the most important thing we should be doing about covid-19 right now today, sunday, september 19th. chris: dr. collins, thank you. thanks for your time and we'll be tracking what happens next with those booster shots. thank you, sir. >> thanks, chris. good to talk to you. chris: up next, a logjam of work on capitol

but the fda advisers did seem to support boosters for older americans. let's bring in cnn's elizabeth cohen. we knew today's meeting would be contentious. did anyone expect a no vote, though? >> you know what, some people did expect a no vote. as i was talking to sources this morning, it was starting to not look good. the fact that it was so dramatically no that the vote was so overwhelmingly no, i think that was surprising. but let me talk about why they voted no or one of the reasons they voted no. the sort of theory put out there was if you give everyone boosters, you're going to cut down on infections. so younger people won't be infected. and we know that younger people after they're vaccinated if they get infected they're usually fine. but the theory was, oh, maybe those young people will spread it around, and that will be bad. and i think a lot of people question that theory. people question the theory of whether it was worth giving boosters to people under the age of, say, 60. so let's take a listen to dr. paul offit, an infectious disease special

few days, the cdc's advisory committee on immunization practices got emergency authorization of the fda for the booster doses of a pfizer biontech-pfizer -- vaccine. this is a moment of great important health to many americans. analyzed the data to make concrete regulations. they are tasked -- their task was not easy and their resulting discussion reflected the tension of the moment. between the individual alkylation of risk and benefit and the impact on society. i listened intently to all of this. i listened to opinions and perspectives and i applaud the committee's perspective commitment -- commitment. i endorse the recommendation that all people 65 and older and those 50 to 64 years old with underlying medical conditions should receive a pfizer booster shot if they received the primary series. i also endorse the recommendation to allow 18 to 49-year-olds with underlying medical conditions to receive a pfizer booster shot. these recommendations will help strengthen protection against severe disease in those appellations who are at high risk of severe complication from covid-19. at the

then the data will be presented to the fda and the fda will make a determination whether they will grant that under an emergency use authorization or some other mechanism. they should be getting the data at least in one of the companies by the end of september. >> do you think it will be authorized before thanksgiving? >> i hope so, wolf. you know, you don't want to get ahead of the fda. they're an independent organization. they'll do their thing. they do it very well. they preserved our safety of people in this country with interventions like vaccines and they make a determination if it's effective. i hope that gets done quickly so we can get those younger children vaccinated. >> i hope so too. dr. fauci, thanks for joining us. thank you for all you're doing. >> thank you very much, wolf. thank you for having me. >> thank you. >>> just ahead, texas enacts the most extreme abortion law in the united states. what it means for the future of roe versus wade. that's next. where we've just lowered our auto rates. ♪ ♪ ♪ ♪ and savings like that will have you jumping for joy. now, get ne

i don't want to get ahead of the fda deliberations. the fda suggestions this will be the case and i understand, sanjay, you're laying out the data but dr. jha, it is a little jar jarring, i think for a lot of people that they kind of don't know what to do or what to believe. >> erin, thanks for having me back. dr. gupta is completely right about the data. the data is that people over 65, people otherwise are high risk should get a booster and that's where the fda panel landed and that was exactly the right call. you know, in terms of young healthy people, the data is just not there yet. i suspect at some point they will need a booster. if you think about the eight-month math that the white house has laid out eight months after your second shot, most of those young healthy people probably got their second shot in april or may, they may not even be due until december or january. we'll have more data by then and see where things go. starting with high risk people make sense right now. i think that's really the group that requires it and i

to gerri willis who's been keyed into the fda's hearing all day long. what's at the center of the debate, i guess, that could swing one way or the other? >> reporter: it could. we're going to know in short order whether this particular panel okays the booster shot. but let me tell you, six and a half hours in, it's not at all clear what they want to do. but let me give you some takeaways here. lots of complaints about pfizer's application. it was based on studies of less than 400 people, that no young people were included and that the period of time studied super short, just a couple of months. her using data from israel -- they are using data from israel and other places. the fda has said haven't had time to independently verify some of these studies, but i want to give you a sense of the conversation. so listen to what we've been hearing all day long. >> there is clear rogues of vaccine -- erosion of vaccine protection over time against covid-19, and emerging data indicates loss of protection against hospitalization. we need to maintain high vaccine e

that is what the fda is waiting for currently. they have what looks like enough data for pfizer to make a recommendation, but for moderna, they don't have such because they received ua approval much later than pfizer. so i would caution maryland about going out and getting a pfizer vaccine and waiting for the moderna day to return. >> dr. lahita, this viewer question is one we've gotten quite a few times recently. about the covid vaccine and flu shot. margaret is asking can covid booster shots or initial vaccinations be given concurrently with flu shots? >> what's the recommendation? >> get one or the other and wait two to three shots. both of the shots have adverse reaction for some like headache, fever, muscle aches. i'm advising her patients to get the flu shot right away, when it comes out, then wait two to three weeks to get the booster shot if the booster shot is available and recommended by the fda. >> our next viewer question is another one we've been getting a lot. this is deb. do we have any updates on a johnson & johnso

but it's something the fda still has to green light, and now two retiring fda vaccine scientists are part of a group of efforts who say data does not support getting booster shots right now. cnn medical correspondent elizabeth cohn joins us with this. this is the latest chapter in the debate over boosters. walk us through it. >> it really is interesting. when you think about the discussion at the end of last year, about whether or not to approve a covid-19 vaccine. there was no debate. everyone was on the same side. these vaccines are a great idea. there's a lot of debate about the booster shot programs. i'm detecting bitterness when i talk to people involved in the decision making. let's look at the big picture. why would want to get a booster, you want to get a booster if the vaccine's strength has diminished over time, or if the delta variant came in, and the vaccine wasn't designed for the delta variant. there's various studies that slow whether or not a booster would be needed. an article by two fda scientists, as well as hopes from the world health organization and other places

and the fda and the cdc they got to officially weigh in on this. and i think there's a lot of back and forth on this. jeff ziens was asked specifically about this and here is what he said. >> we have also been very clear throughout that this is pending fda, conducting an independent evaluation and cdc's panel of outside experts issuing a booster dose recommendation. >> so kaitlan, they always said that, they always said we have to listen and hear from the fda and hear from the cdc but they put a date on the booster, september 20th. so i think it's confusing and i think that's led to some of the back and forth within these organizations. >> yeah. when you put a date on it like that, even though you're saying, well, if the fda and cdc say it's okay, september 20th you're going to get the booster shots, that puts a lot of pressure on the scientists who have to make that decision. >> yeah. raises a lot of questions, too. now people think i'm getting a booster starting september 20th and the fda and cdc looks like they are but no one said the t's are cr

now it goes to the fda. the cdc advisory board meets next week. but right now the administration feels at least for this high-risk population it is on track for boosters potentially as soon as next week. >> let's bring in cnn's chief medical correspondent dr. sanjay gupta. their announcements weeks ago were coming for everyone, that that did not get ahead of the science and did not put political pressure on the fda. but listen to the fda's former chief scientist this morning talking to cnn's brianna keilar. >> the cnn's committee of outside experts will be ready to start this booster program during the week of september 20. it will be easy. just show your vaccination card and you'll get a booster. >> that obviously was not the bite i wanted to run. the bite i wanted to run, the former chief scientist said what i do think was backwards and not helpful was that the white house made an announcement with a certain date before really all the data had come in before fda had had a chance to review it and before there was this public discussion that we're

tech package went to the fda and again are mr. announcement was for people who got pfizer rated and aside from the process of worked and there's a vaccine advisory board to the fda, that met with scientific and the fda authorized it. my vaccine advisory board, the immunization practices the advice and then i made the recommendations and for the most part, we were doing a lot of consensus so after listening to all of this science and fully endorsed, the same boosters and for people longtime care facilities and for people in high-risk illness pretty and people with underlying medical conditions. and we listen to the science and also going with fully aligned with what the fda panel said. and many in our state advisory panels and as well which was the visitors for people or in high-risk settings rated these were health care workers. [inaudible]. in our frontline workers. >> these recommendations very specific. there were certain people who should give boosters that includes the over 65 crowd, older group with comorbidities and their b

those are decisions made by fda and cdc. as i said before, what we have done is purchase the boosters so we are ready so we don't see this horrible spectacle we saw in december where vaccines were approved but you couldn't get them, you didn't know where to get them, we didn't have the supply, we hadn't purchased enough vaccines for every american to be vaccinated in december. we're ready to go once the science says go. >> i just want to clarify, it sounds like what you're saying is it is possible september 20th, that week will come and the boosters might not be ready to be approved. >> dana, let's not play games about this. so what i'm saying is we will go when the fda and the cdc say go. i think the reports out of both agencies are that at least some of the boosters for some people will be ready that week. but we are going to go whenever they say go. >> got it. okay. let's talk about unemployment benefits. at least 7.5 million americans are going to lose expanded unemployment benefits when that program expires tomorrow. pr

senior team and the whole staff at fda, especially during the pandemic fda has strong leadership in dr. woodcock and peter marks >> acting commissioner coming out with a memo to staff saying in part we put together a plan that will allow us to continue prioritizing science while meeting timelines that are important to ensuring the end of this devastating pandemic. there's a lot on the fda's plate when it comes to covid vaccines. the boosters ahead of that september 20th plan for potentially making them available broadly. vaccines for kids. pfizer's vaccine for one age 12, that's expected to come up in the november-december time frame and they have moderna's application for full approval. a lot for the fda to be doing on vaccines right now >> meg, you didn't answer your question about whether there was concern about politicalization or concern about the cdc what's the scuttle but >> he was reading from a paper he reiterated their confidence in the fda but the reporting i'm doing suggests there's concern about political pressure and a similarity to the way the biden administration handle

the fda should be handling these issues. i think in my perspective, i was in congressional relations officer treasury for 12 years, i've seen bureaucracy a little bit. and i think that this is a move of the fta trainer get some control of the ppp program while it was run well by the banks. they see the writing on the wall that if we turn over the -- where we can minimize fraud and do better for our customers, that they are going to lose some of their power. so i think that this may be not so much to help everybody but just as a bureaucracy looking out for itself i want to do some housekeeping items with you madam chair. when do you think that we're gonna get secretary of treasury yellin to fulfill your duties and testify before the committee in person? >> we are working to get her to come as well as the administration. back discuss to discuss the ppp forgiveness. we are working on the reconciliation package right now. so my guess is right after that we are going to have the administration come in. >> to your credit, i know y

how quickly do you anticipate the fda to make a decision? i think that they will make a decision rather soon particularly because there's been so much momentum so much pressure ucs. that's dr. george rutherford explains. once the decision is in the hands of the cdc boosters could be rolled out within a week. i think very quickly actually. again, this is a recommendation for emergency use authorization not full approval the fda of course will consider it and then make a formal recommendation to the cdc which is expected by next week in the newsroom stephanie sierra abc 7 news something. i'm sure we will continue to follow stephanie. thanks now. we do have an entire vaccine team dedicated to getting you the latest information. you can ask them your questions by heading to abc 7 news.com slash vaccine and click on that big blue box the fourth day of the theranos trial in san jose featured internal documents. indicating former ceo elizabeth holmes knew the blood testing machine was faulty, but the issue was not disclosed to patients or to invest

a final decision won't be made until the fda meets with the cdc this week. a lot of people left wondering what they're supposed to do. >> one of the greatest errors that took place at the beginning of this was mixed messages. >> reporter: meanwhile, a whole new age group could soon be authorized to get the shot. pfizer says a smaller dose of its vaccine triggers a strong immune response in 5 to 11 year olds. authorization for those younger children could come before halloween. >> this vaccine could not only prevent school closures t could actually get us out of one of the most horrible phases of the pandemic we've experienced yet with the delta variant. >> reporter: health officials warn that although children are at far less risk of getting severe covid, 30,000 kids were hospitalized in august. >> all you need to do is to go to pediatric hospitals around the country, particularly in the southern states, and you will see that there are many children that are hospitalized now for covid-19. >> reporter: pfizer now saying its vaccine is a safe and powerful tool

infighting at the fda has led to a lot of concern. the fda won't say whether or not it plans to back pfizer's covid booster. the fda says it hasn't independently reviewed all the available data and the studies. what does that mean for all of us? there appears to be some debate over how effective it is over time. some say it declines over time, others say it does not. pfizer is recommending potential booster shots eight months after your second shot. just today, pfizer said a booster shot six months later restores protection from infection to 95%. so who do we believe? what do we listen to here? bringing with us here our covid expert, dr. peter chin hong from ucsf. why the infighting at the fda? people are resigning because of this booster debate. can you shed some light to this? >> yeah, it all depends, raj, on what your definition of efficacy is. if you look at anti-bodies, sure, they're going to decline, they don't stay up high because they're just going to clog up your blood. we have other immune cells elsewhere like in the lymphat

we'll talk to two of the top doctors alongside the fda and cdc coming up. plus the latest on the humanitarian crisis at the southern border. as dhs secretary prepares to answer reporters' questions in del rio, texas moments from now amid the scramble to to handle the people. >>> welcome to meet the press daily. i'm garrett haake in for chuck todd on a busy monday. we expect to hear from homeland security secretary on the influx of haitian migrants on the southern border. we'll wring it live it happens. >>> this morning the first step in the news so many people have been waiting for. pfizer says the covid-19 is safe and isketive for children ages 5 to 11 and says it will submit the data of the fda by tend of the month. this is welcome, welcome news for parents. and we'll have much more on that in just a moment. it's also a development that the white house and democrats in congress would love to be celebrating today. but they find themselves in a web of interwoven standoffs where nobody is blinking. i'm thinking like reservoir dogs. and if they don't figure a

but some at the fda are questioning whether they're truly needed for everyone. others making the case that boosters may only be justified for older americans right now. >> this data is persuasive. it's quite persuasive to me that it will be wise to give boosters to people over the age of 60. i am not convinced that this data is persuasive to give boosters to everybody. >> reporter: if the fda gives pfizer boosters the green light tomorrow, a cdc panel will address the matter next wednesday, meaning those third doses could be available by late next week at the earliest. moderna is expected to seek thunderstorms for its boosters within the next few weeks. >> we have to vaccinate the 80 million americans who are still unvaccinated. giving more vaccine to the 180 million americans who have already been fully vaccinated is not going to change that. >> reporter: and the pandemic still raging in the u.s. 2,000 deaths reported on wednesday, the highest single day total in seven months. officials in idaho calling the situation dire, all hospitals can now ration care if n

where does the fda stand? y nglel getting a little bit better. we're better cooks... better neighbors... hi. i've got this until you get back. better parents... and better friends. no! no! that's why comcast works around the clock constantly improving america's largest gig-speed broadband network. and just doubled the capacity here. how do things look on your end? -perfect! because we're building a better network every single day. >>> three, two, one! >> ignition -- >> thrilling to watch history being made tonight. why this space mission is unlike any other. >>> plus -- and good news for firefighters. i'm tracking some rain headed towards northern california and what our bay area rain chances are. >>> and finding the miracle cure for covid. is there a delay? we investigate research bottlenecks that are delaying potential treatments. >>> and the growing confusion over covid booster shots and whether or not you should make an appointment for one as early as next week. good evening. i'm raj mathai. a simple question with a complex answer. do you nee

but first, they need that green light from the fda and cdc. that approval of the children's pfizer vaccine is expected late next month. the goal is to offer at least a first dose to 75% of kids in marin county. >> so in order to do that, we are working very closely with marin county office of education todentify opportunities to have both school-based clinics as well as some one-day larger clinics to make it easy for families to access the vaccine. >> marin county will also work closely with pediatricians to resolve any refrigeration or storage issues. the vaccine will be optional. public health officials say they have seen no long-term side effects among kids 12 and older who have received the vaccine already. >>> we're following some breaking news now in the south bay. a deadly shooting in san jose. it happened at colmar and story. this is in east san jose around 8:00 this evening. police sources tell us a woman was shot and killed. it's unclear what led to this shooting. we are following the very latest both on air and online at nbcbayarea.

as a vaccine advisory board for the fda, that meant scientific to liberation and fda authorized it. my vaccine advisory board immunization practices went and they gave me advice and i made some recommendations and for the most part, there is a lot of new so after listening to all of the science, i fully endorsed vaccine boosters for people greater than 55 and people who live in long-term care facilities and for people high risk of severe illness for people with underlying medical conditions where there was a scientific close call, i listened to the science and ultimately ended up going with fully in line with what the fda advisory panel said and what many in our cdc advisory panel said as well which was to endorse boosters for people at high risk settings because of where they work or live, healthcare workers and grocery workers and frontline workers. >> to clarify that a bit, the language was very specific, there are certain people who should get boosters including over 65 crowd, older groups and comorbidities and people who make it boosters, delineation between recommended and bei

i think the fda today is going to say, one, is it safe to get a third dose? number two, does it actually do what it's supposed to do, which is rev up that immune response or antibody response and the third key question is, what you highlighted, who should actually get it? i think what they're trying to tease apart is who really is at risk for not having a booster dose, and who is end p up in the hospital? who is ending up with severe disease, and who would stand to benefit the most from a booster dose? >> dr. fauci said that he strongly believes and the data strongly suggests that pfizer booster will be recommended. we also have those two outgoing fda officials who say that there is no evidence that the general population needs a booster. this is not like a slight, nuanced disagreement. these are polar contradictions. should we have expected this? because we've not followed this process of fda approval and authorization closely like this in recent history. is this common? if not, why are we seeing a contradiction like this? >> i think it's necessary. i think

do you think the fda officials should ignore the advisory committee's recommendation? >> no, not at all. jake, i don't think they made a mistake, and they -- the fda absolutely should not ignore them. as we said in the beginning, we would want to plan for the possibility of vaccinating all those who have gotten their initial vaccination with pfizer, and it was always pending the evaluation of all of the totality of the data, from the united states, israel and dmi bit of data we could get by the advisory committee to the fda. they did that in the proper deliberative process and they came up with a recommendation which i think is a good recommendation because if you look at everyone over 65, and people from 18 to 64 with underlying conditions that make them more likely to have a severe outcome, and those who are 18 to 64, who by either institutional or occupational situation put them at a higher risk for exposure and infection you're going to get a pretty good chunk of the population. i don't think they made a mistake but the one thing i think people need to realize that

that is who the people the fda and the cdc said should get that booster. president biden is in the category of people who should get the booster. and there are people who the fda and cdc are saying they are allowing to choose to get the booster if wish. that is people over the age of 18. so all adults with an underlying medical condition or high risk of occupational exposure. they could make a decision with their doctors if they're six months out on whether they should get a booster versus you can and are allowed. those who should should try to do it relatively soon in the next several weeks, everybody else could wait and think through the risks and benefits when it comes to their own risks of getting covid and whether they want to get a booster at this time. >> is there any risk to getting the booster too soon. if you get it at six months instead of eight months, is there any risk? >> well right now the cdc and the fda are recommending after six months. soft eight months is what is the biden administration said. that is par of the confused messaging. but

they're waiting to hear what the fda and cdc are going to do. but if they're hitting that eight-month period now, what should they do after the decision is made? >> so, listen, i'm among them. i finished, i got pfizer, i finished my second dose in early january. i am fully eight months out at this point. i am waiting for fda approval. in the meantime i am masking when i'm in public locations. i am eating outdoors if i go to a restaurant. and i am being careful about who i spend time with, making sure that they are fully vaccinated. if you do those things, you are going to remain protected. again, if you're immunocompromised, go out and get that third shot because it's already been approved for you. but, remember, even the current doses of vaccines still protect you so well from hospitalization and death. we are not back in early 2020 or even early 2021 for those of us that have not received boosters yet, we are still protected against the worst effects of this virus. >> i think that next meeting is september 17th. so we'll wait to see what they

too late. >> pfizer got the full fda approval and your father was already sick. evan, talk to me about your final good-bye to your father. did you have a chance to spend any real time with him? >> not really. i was already staying at another house, and he was just coming by to pick something up and he didn't want to get too close because he was too worried about getting me sick so i didn't even get to hug him before he left, and then before i knew it, he was gone. >> you guys are vaccinated now, evan. what was the message ultimately that your father wanted to spread about vaccines? >> he wasn't anti-vaccine. he was just hesitant and now that, you know, pfizer has been fda approved, i don't think he would have anything wrong with telling people to get that vaccine. >> his final words to my stepmom on a facetime call was that he wishes, he wished that he was vaccinated. >> those were his final words? >> to my stepmom, the last call that she had with him, he said that he wished that he was vaccinated. >> katie, you said from one media source in particular he was get