fda has issued five related euas previously, including the eua for biontech covid-19 vaccine for children 12 years of age and older with or without compromised immune systems, and it's a booster dose. each dose has 30 micro grams of mrna. the biontech covid-19 vaccine, as it's also known during development, bnt192b2, with active immunization in preventing covid-19 in individuals 16 years and older. it is also a two-dose series, three weeks apart. i'll discuss the study design. study 1007 is an ongoing placebo-controlled study in children 5 to 11 years of age. this slide provides a dose finding of the study which evaluates the safety of three dose levels at 10, 20 and 30 micrograms. formulation used in study 1007 was the currently authorized formulation, to administer the 10, 20 and 30 microgram dose levels. there is one component to place in the u.s. and enroll children who were not at high risk of sars cov 2 and did not have a sars cov 2 infection. sars cov 2 15% equalizers were set. approximately 42 participants were enrolled in phase 1 portion of the study. we enacted the data for the

the balance of the benefits and risks is essential to any eua request and decision. nor more so than in today's discussion. benefit risk consideration and consideration on data to support emergency use authorization of covid-19 vaccine, the use in pediatric age groups were discussed at the june 10, 2021 meeting. the benefits of vaccination can be assessed via clinical efficacy trial that generates data to demonstrate kobe to infection or covid-19 disease. we can rely on established regulatory approach in which immune response biomarkers in a pediatric age group are compared to thosey elicited in a reference group or comparative group for which clinical and efficacy of the same vaccine was previously demonstrated. for example younger adults who were enrolled in efficacy trial. in terms of risk, these are assessed and pediatric age groups by safety evaluation and pre-authorization clinical trials and rolling participants of that age. and also, these risks are considered in the context of the safety profile and risk described in older age group. duringer the june 2021 m

read page two of the memo from the fda this is the pfizer vaccine is still under eua and you are notowed to compel or force anybody to take in eua treatment by medical ethics. >> laura: real quickly, what's next for you? are you filing a lawsuit? >> we are looking at our legal options, don't want to give my hand up too much but we are certainly looking at those options. >> laura: we are going to be following your case as well as many like you, a lot of people around the country for whatever reason it's not right for them at this time. this is wild. we are going to lose a lot of great doctors and health care providers out there. thank you. and if you are one of the thousands left grounded by southwest airlines this weekend, the company would have you believe the cancellations have nothing to do with the employees who protested its vaccine mandate. somehow only impacted one airline really. as the ap notes, the widespread disruption began shortly after the union asked for a federal court on friday to block the airline order that all employees get vaccinated. joining me meat out, stand p

they already issued an eua for 12 to 15-year-olds and the state is saying this will only take effect when it is fully approved by the fda. if anything, the fda only goes on the side of doing everything possible to ensure the safety of the individual. they are a conservative organization. what i would say to parents is these are very safe and by the time they are approved you can be sure they are going to have a lot of person safety data. >> how do you distinguish what's supposed to be the authentic science that you should be looking at and not something that you pick off some random website? >> this is actually what is happening right now with the mrna vaccines, period. i will say a lot of information that you can get off a website is that they front safe. i will tell you they have been around ten years. they started envelopements for something called mers, a coronavirus like this, they have been used for tumor vaccines and now they became the most powerful vaccine we have for the coronavirus because we happened to have the pandemic when we have the technology. they are safe. one thi

the mandates might come in. >> in terms of the mandates, now we're really starting to now that the eua floated as to whether a coronavirus vaccine could be added to the list. away is the sense from officials that you're speaking with as to how that can go and if it's an eua that would do that or await full approval. >> i think what i'm hearing is this could really be a state by state thing and that it really would be sort of something to do later when there's full approval. school children are required to get all sorts of vaccines, but those vaccines have approval, not authorization. so there is this tradition of requiring the children get vaccines before they go to school. let's take a listen to something that the surgeon general ha h had had to say about this. >> part of the reason you're going to see states move in that direction is because we all want our kids to go back to school and stay in school and to be safe. many people think that covid is not a big deal, but i will tell you we lost hundreds of children to covid. thousands have been hospitalized. and with could prevent a lot

he did say eua. when we look at this, we know we have this timeline for the advisers for when they're supposed to meet. could the fact that they're officially asking for this eua now, could that in any way change the timeline? >> i think that now that we have this application, that means that the advisers will meet somewhat quickly. that's what happened with the adults and so we can bet it will happen, it is not going to be a long time. >> well, it is all very good news to start off the day. elizabeth, thank you. >> thank you. >>> there is more breaking news this morning. it is a busy morning. several former trump aides are now facing a deadline to answer subpoenas from the january 6th house committee. the group expected to defy the request for documents tied to their communications on the day of the insurrection. >> and also just within the last hour, the senate judiciary committee releasing a damning report detailing how trump and a top doj lawyer attempted to overturn the 2020 election. cnn's seni

expanding the eua for children is unnecessary, premature and will do harm than good. slide two. there is no emergency for children especially healthy oneness whose risk of severe illness or death is almost nothing. kids with pre-existing conditions and prior infections will not be included in pfizer's study, so including them in the eua. slide three, correction, 2268 members for all subjects. pfizer's trial is woefullyth underpowered for the safety concerns such as myocarditis just like the adolescent study was. and if they were not able to detect an unexpected a safety concern there, they wouldn't be able to hear. in pfizer's study, only .5% of the controls were dropped due to important protocol violations versus 3% in the treatment group. the odds of that happening by chance are one in 10,000. this deviation ispe poorly explained at of the study is not double-blind and may be subject to bias. most safety monitoring programs have not reported results. why not wait? slide four. the cdc reports, we can expect that for every 18 child hospitalization prevented, at least 43 will end

do i think it's sufficient to allow an eua, yes, i do.e of benefit and risk tips in favor of granting the eua for kids 5-11. liz: well, let's just put this up because i want our viewers to know, i know some of you are in the car, so you can't see, but it's important to put the banner up that says that the voting is happening right now for this. the benefits, obviously, outweigh the risks, that's what i'm hearing you say. however, there are risks, the myocarditis, higher incidence in males in their upper teens. anything to worry about there? >> yes. i mean, always. whenever you have a side effect, you want to know more about that. and, in fact, even for adults and older kids the fda has required ongoing studies. that's appropriate. actually, they go out about five years looking at consequences of myocarditis9 and per car diets. but you put that in real estate to covid which probably causes a 7 to 11-fold higher incidence of covid, and it becomes an easier calculus to do. now, one proviso. if this current trend continues where we really hav

let's start with this j&j request for an eua for a booster shot to its one dose vaccine.olks? do you see any reason that it would not be granted, that emergency use authorization for a booster? >> no, i think it will be, erica. i think really the data, it suggests that, you know, one dose may not be sufficient. in fact, this could have easily been a two-dose vaccine. and the reality is the question then is it a booster? are we completing a series? it is unfortunate because it is nice to have a one-dose vaccine against the disease, but it may be we were asking for too much. >> i want to look at new data here that relates specifically to the pfizer vaccine, which is, of course, the one that most -- the vast majority of americans have been vaccinated have gotten. it shows two things. good and bad. hospitalization after five, six months remains the protection, i should say, against hospitalization remains very strong. but the protection against infection wains over time to 47% six months after the second dose. for folks at home, who may have been vaccinated like myself with p

already, they have applied theya eua.here were no group at all and there were eight deaths in the other. kristen: are basically four capsules twice a day for five days. >> a lot of pills, but a short course. kristen: i know it is cheap compared to the monoclonal treatments, but still, the fear is people will see this as if i get it, i will take this but that costs a lot to the federal government than just the vaccine. >> didn't we all learn this asri children -- an ounce of invention is worth a pound of care. there is no question preventing infectious diseases so much better than treating it. but there are two groups where this will be useful. one is we haven't gotten everyone vaccinated. so it will be used for the unvaccinated and there's hope in the future if you have a mild-to-moderate rate through infection, that you get this pill and go on your way. you get tamiflu when you have flu, you take the five day course and you went home. so there is a lot about an oral pill. right now, the government govert committed a bill

and that is, vaccinating school children but not going into effect, of course, until the eua for 5 to-olds takes place. what do you make of this mandate? how could it change the game? >> well, you know, we talk a lot about the concept of herd immunity and for better or worse, that number always includes children. it's not -- we don't and cannot achieve that with adult vaccination and adult infection alone, yasmin, so you know, the pfizer's data is sitting with the fda right now. they are meeting in two weeks, the advisory committee, to review the data and will presumably grant or recommend authorization to the fda, and if the fda agrees on that, then the cdc has a meeting planned, actually, for the week after so we're talking about three weekends from now where the 5 to 11 group could very well begin to be vaccinated. i wasn't sure if scott said they could mandate it until it receives full approval as opposed to an eua so i think they're going to get a lot of pushback from those conservative pockets and those parents who feel that it is, you know, going against their rights, but it is

on tuesday the fda advisory board will meet to discuss eua approval officials in some states already getting ahead of an expected authorization. >> in just a few days' time, millions of parents all across the united states should be able to breathe a sigh of relief. >> reporter: pfizer says its two-dose pediatric shot, which is one-third the adult dosage is more than 90% effective. while moderna just announced its covid vaccine for children triggers a robust immune response with mostly mild to moderate side effects. near ly 30 million children could become eligible but being eligible and being vaccinated are two different things only 30% of parents say they would get their children vaccinated right away. this mom of four in kentucky is not one of them. >> it's so mild in kids like why why even risk it on them >> reporter: university of indiana sociologist looked into the underlying factors with a group of 80 moms from different backgrounds. were you surprised by how many parents in your group are vaccinated themselves but aren't going to get their kids vaccinated right away? >> absol

concerned about safety and they will ensure it's safe before they put the final approval on it from euaall right. hey, i'm gonna ask you to do something very difficult try to forecast the the future at least the near future. okay. now that the cases are going back down in all 50 states. leave and the delta search appears to have subsided. do you think that we may get another way this winter or do you think we are now winding down looking good and perhaps moving from pandemic to endemic? i really do think it's the latter and i know people will all say oh, she said that between alpha and delta, but i was wrong. i mean that wasn't totally wrong that it delta, you know, we got protected in the state of california because we had higher rates vaccination. but the reason i'm just gonna do the quickest reason to tell you we had a 62% sour prevalence rate by the which means antibodies in the population by the lowest possible estimate before delta 62% we have had 38 million additional vaccines then that brings us up. 75% are prevalence we've had unfortunately at least 30 million new infections, p

if you look at a a this this person should be getting booster, however, i said june and the actual eua for the pfizer booster is six months after the shot. it is not been six months since june. oh and we are allowed to mix and match vaccine. so modern is okay if you look at b this amazing video game player who lives at home got modern on march. that is the correct time. in more than six months, but the modern boosters actually half no it's not full dose. okay, and that is important if you're gonna run out if you're gonna run out and you need to specify that you're getting a booster and you're not getting your primary series if you're gonna get more darna and see see is important because it comes down and making sure that you know your options. is a valid is a valid decision if you're going to get the j&j sean you all the sudden want to get a different one because of what you've heard with data. so this 19 year old it doesn't matter above 18 two months after the j&j shot and it is absolutely acceptable to mix and match there. you have it. oh boy, there were so many details in each of th

could this official request for an eua, could that change the time line at all?i really hope not because the fda has already said that they're approached authorization for the vaccines for 5 to 11-year-olds with urgency. this is the reason why they already set an advisory committee meeting for october 26th, pending pfizer submitting their application on time. submitting it now, today, gives the fda enough time to review the data, and i think there's a real possibility we could have the first shots going into arms by the end of october if all goes according to plan. we have to remember, too, in theory, it's possible the fda could come back and say, we need more data or that maybe only a smaller group of children, perhaps those with higher risk may be immediately proved. this is not a given, but i do very much trust the fda going through a rigorous and careful process to ensure safety and effectiveness. >> dr. wen, i'm eager for my children to get this vaccine as well as myself. it is understandable that some parents might be less in a rush to do so for their kids

a reminder that an eua is not a permanent situation and it could change based on either additional sideta or depending what happens with the pandemic. >> thank you. >> thank you, dr. monto. i guess for me it's always nerve-racking i think when you are asked to make a decision for millions of children based on studies of only a few thousand children. so i guess the way i try and deal with this is it is never one you know everything, you never know everything. the question is when do you know enough? we certainly know there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sickened or hospitalized or die from it. then regarding the mio carditis issue i think there are a number of things that are reassuring. it is reassuring we're giving the lower dose, the incidence of mio carditis in 12015-year-olds is less than the 16 to 29-year-olds and that the general -- it was not generally a phenomenon in a pre-pubital child or less so. we have efficacy data 91%. that will hold up i think. i know enough to move forward with a yes vote but it

keep in mind that moderna was approved and eua approval after pfizer and there's delay in the data and additionally the pfizer data comes from israel which was way before in terms of authorizing the vaccine and so they have a much longer history of data. look, this is an opportunity to get in front of it and to buy it because i also expect mix and matched to be approved later on today when the panel votes and why would you ever take a j&j, bo booster or a pfizer so i'm not concerned by this. >> that's one investor's opinion, someone who is long moderna and let's just throw that out there and make that clear that it's your opinion >> well, actually, it's not my opinion in order of it being effective. that's in the data >> i understand. it's why would you ever comment. i've got you no, that's true. i agree. >> we'll have more on this, if we do have more developments on this certainly moving forward. by the way, i don't see much of a negative impact and maybe the dow's lost 20 or so points over the last 90 seconds since we started talking about the moderna delay as being reported by "the

we get this eua, authorization for the pfizer vaccine most likely coming out in early november.nt to see another surge and the vaccine is key to that. >> heidi, quickly for folks listening or watching on sirius satellite radio. does the plan call for direct distribution to pediatricians? will i be able to take my child into the pediatrician and get the shot in the doctor's office? >> they do say they will have that access either at pediatrician offices, pharmacies or in clinics set up inside children's hospitals within days of the authorization. they say they have enough supply secured already for all 28 million children between the ages of 5 and 11. >> all right. great news. doctor hills, your initial reaction to the administration's plan? what do you think? >> i think it's really smart to have a plan to set things up in advance to be able to give these families access to this vaccine. it's one of the major gaps we have in our coverage right now. this pediatric population, and that's 22% of the u.s. population. that's showing up in our infection rates. right now 25% of our case

million courses over the next several months and they're already producing the drug -- getting ready for eua and potential approval. >> but it doesn't take the place of a vaccine, right? >> no. >> and are you concerned that this could give people who are still vaccine hesitant having gotten vaccinated with a false sense of security and one more reason, one more excuse to not get vaccinated? >> i am concerned about that and i think ultimately it's better not to get infected than to try and treat an infection, but it's another tool in our toolbox. we're never going to be able to vaccinate everyone in this country. we're just not going to be able to penetrate folks who are so resistant, and having a very active antiviral drug as this drug appears to be will go a long way to reduce the mortality rate further. one thing i'm frustrated about is, you know, we did as you mentioned in the lead-in, we've lost 700,000 americans now and fully 200,000 of those folks have died since vaccines have been available almost to everyone in this country, and every one of those deaths is unnecessary. so even thoug

their deliberation is although it was almost unanimous that they endorsed the authorization for the eua, what was not necessarily implicit there is that they recommend blanket vaccination for every child in this age group. you know, one of the members we've had on air, paul offit, sometimes you have to make a decision when you don't know everything but know enough. in terms of side effect profile, it appears to be well tolerated. sometimes we don't see rarer side effects like myocarditis, it was really are we concerned about this in this age group. we don't start to see that until the vaccine rollout happens in kids. the great thing that the administration has done is really tried to prepare pediatricians' offices and schools as well as pharmacies and hospital systems to be the ones to deploy the vaccination. we're not going to see this at the javits center. parents need to have a conversation with their health care provider so they feel their decision is informed, they understand the fda has come to the conclusion that the safety and efficacy profile and the benefit does outweigh any p

we know that pfizer has submitted a full eua for children 5 to 11.e group. it will help to prevent and break the chain of transmission of this virus in of virus in this community. >> that could not come enough. doctor, thank you for the clarity this morning. >> earlier in the show, we asked why are you awake? >> meribeth writes these two are up too early. >> we are up way too early, heading to atlantic this weekend. it will be fun. the weather will be good. >> now we know here that bill karen is famous running the best ties in the network. i assume it's for bill. there is a possibility maybe this one. we like it. i am open to any suggestion. up next, a look at one big thing. we'll hear on firsthand account for a school board official facing hostility. >> steve van zandt is our guest this morning. "morning joe" is moments away. g "morning joe" is menomts away. lisa here, has had many jobs. and all that experience has led her to a job that feels like home. with home instead, you too can become a caregiver to older adults. apply today. ♪ ♪ your new phar

they're starting a full court press ahead of that meeting for potential eua recommendation and the fact that they are driving home this point that they are targeting 25,000 doctor office community health centers. this is all about making parents more comfortable and putting it in a setting that they know. >> yeah, good morning. thank you for having me back. there are several things going on here. one is just the logistical stuff. these are different doses than the ones for adults. what we don't want to do, what happened with the trump administration is there was no plan for implementation. we don't want to do that. we want a plan ready for implem implementation, so the day after the cdc signs off on it, kids can start to get vaccinated. a lot of parents are extra careful about their children and want to turn to their trusted voices, pediatricians among them. the white house is working with pediatricians among others to make sure vaccines are available where parents want them. >> in addition to expanding the age group that will be approved for vaccination, we're also expanding the groups

so this really opens the way, hopefully, for full fda -- sorry, for eua, actually, of the children's vaccine for pfizer. and we have about 28 million 5 to 11-year-olds who are eligible. >> dr. uche black shock, thank you very much for being with me this morning. appreciate your time. >>> back to washington. the president said during a cnn town hall last night that he thinks that there will be a deal soon. he also provided more details about what will likely be in the reconciliation bill and what may not make it. the president shared more about where arizona democratic senator kyrsten sinema, who hasn't spoken publicly about her views on the bill, stands on key areas. >> she's smart as the devil, number one. number two, she's very supportive of the environmental agenda in my legislation. very supportive. she's supportive of almost all of the things i mentioned relating to everything from a family care to all of those issues. where she's not supportive is she says she will not raise a single penny in taxes on the corporate side and/or on wealthy people. period. and so that's where it s

suggests it may [inaudible] in addition, the 5-11 years of age is lower than the previous under rsthe euait may be lower with age 5-11. the vaccine safety [inaudible] [inaudible] for the next, i will present scenario one. i will remind you [inaudible] the week of september 11, 2021. the vaccine efficacy, 70% against the cases and 80% against hospitalization. the rate of excess myocarditis from optimum data for ages 12-15-years-old. for males age 5-11 covid-19 the vaccine has been authorized [inaudible] on the left side, there are four endpoints. prevent cases, hospitalization, icu stays and death. on the left side, there are the endpoints with minor cases. hospitalization, icu stays and death. when we compare the data, we need to keep in mind hospitalization andd icu stays due to covid-19 [inaudible] do to those vaccine related myocarditis. [inaudible] to monitor the patient conditions as precautions. looking at the tab on the top, age 5-11 years, it prevents about 45,000 covid-19 cases. 200 hospitalizations, 57 icu stays and one death. in the meantime, the vaccine may cause 179 minor cas

and they're already producing the drug getting ready for eua and potential approval. >> well dr. and the medical communer as a whole stressing while the pill could be a game-changer, it is no substitute for vaccines that will prevent most of the serious illnesses. and spread for that matter. since the pandemic, it is just been so confusing for many women and their child bearing years. and men. especially when vaccines became available under emergency use authorization. pregnant moms worried if it was safe for them and safe for their babies. now the cdc wants to make it crystal clear, if you are pregnant, please get vaccinated. and joining me now with more is fertility physician dr. natalie crawford. dr. crawford, good to see you again. we love having you as a guest on the show. the cdc director rochelle walensky said just 31% of pregnant women in the u.s. are vaccinated. what do you make of that number? why is this such a concern? >> i think to put this in perspective, what we know is about 75% of the population has received at least one dose. so this is staggeringly low for preg

between the submission of the data for pfizer for children under 12 for vaccines, and getting that euathe polling of parents who say the majority of them, that they're not going to immediately get their young children vaccinated, you're a pediatrician, also focused on vaccinology, what is the work that has to be done? how do you inform or get those parents to want to get their children vaccinated? >> thank you for that, victor, and that's really a critical question. i think it starts with trusting our process. we have a good process here in the united states and the fda. not a perfect process because we're all human beings, and humans are not perfect, but a very good process that compares very favorably with other countries. it's transparent. the briefing documents are posted publicly. we look at safety and efficacy. i don't pre-judge the data. i take it as it comes. the last meeting we had at the fda, the advisory committee decided not to advise authorization of boosters for everybody 16 and up, rather at this stage to recommend pfizer booster for 65 years and up and those with medica

. >> this is a stop on the train of the eua process. the cdc will have to give its final approval when it comes to the emergency use authorization. you've got parents already asking pediatricians questions, me being one of them, are you going to be offering this vaccine. you're asking your school board, your pta, will you be offering this vaccine inside schools, how quickly is this thing going to get approved and when will we be able to see shots in arms for young kids? >> i think it's going to move pretty quickly, assuming the fda vrbpac committee, the advisory committee, signs off on it in the coming week, and it goes to the centers for disease control, which i expect it will. how eager parents are going to be to get this vaccine is going to be depend on a number of factors. i think you'll see a lot of regionalzation. in the northeast, where the majority of the 12 to 17-year-olds are vaccinated, that's a sign that parents are all in and they'll probably want to vaccinate their little kids as well. here in the south, where it's the rat

why that is important, well as soon as that eua comes out, pfizer could start shipping the smaller kideet tuesday and if the cdc director then signs off, we could see shots going into little arms as early as wednesday. guys. >> nick watt, thank you. >>> buckingham palace said the queen will need at least two more weeks of rest. a lot of questions about her health. we'll have a live update from london. >> and any minute we're expecting to hear from the albany county sheriff's office for an update on the criminal complaint against former governor andrew cuomo. we'll be right back. actually here they are now. this is the albany county sheriff's department and we're waiting to hear about this criminal complaint against former governor andrew cuomo. they're saying they need another minute here. and so -- okay, we're going to get in a very quick break. we'll be back in one minute. (birds chirping) ♪ (upbeat music) ♪ (phone beep) ♪ ♪ ♪ ♪ ♪ ♪ >>> thank you for coming out. i apologize for making you druf drive out to clarksville. but things get restricted down in albany. >> this is charges agai

days away from a full fda authorization when it comes to johnson & johnson boosters and moderna -- euahow soon could those shots be in arms for folks? >> yeah, they could be ready as soon as probably after the cdc committee meets, which is next thursday. so, remember, the sequence, the fda gives its emergency use authorization language, the cdc, which is meeting next thursday on covid vaccines, picks that up, and then gives further guidance, and it's -- that's where kind of the details come for what to do, what not to do for physicians such as myself. so, you could see something literally, yasmin, the next day. now, remember, the moderna boost is half the dose of doses one and two. the pfizer boost is exactly the same as one and two. and then the johnson & johnson boost is exactly the same as the first dose. so you could imagine that, you know, friday, j&j recipients, which is anyone over the age of 18, and so let me emphasize. it's confusing because it's not the same for moderna and pfizer. but if you got johnson & johnson, you should be getting a second shot at least two months from

. >> i'm not talking about the eua. specifically about approval which governor newsom mentioned. about full fda approval. if and when it does have full fda approval for children, would it be added to the list of vaccinations that are corrurren required in public schools? >> we'll see. first i'm waiting for the emergency use authorization. it will tell parents now is a good time to get your younger kids vaccinated. let's start with that. we'll see when we get the full approval what we have to do next year i think. >> as you know, a lot happening and yet not happening at the same time in washington these days. the infrastructure bill that's essentially stuck right now, as we look at i believe connecticut was set to receive some $5 billion over the next five years. what does it mean for your state? what's at stake here if this bill doesn't pass? >> yeah. come on, president trump knew how important infrastructure was, couldn't get it over the finish line. let's let the congress get it over the finish line. that first bill means the world to a state like connecticut which has pretty o

like i said, it would completely be a game changer and merck will seek emergency authorization, the eua sanjay gupta, who has now written a second book during covid. the author of "world war c, lessons from the covid-19 pan pandemic and how to prepare for the next one." that comes out on tuesday so you can preroorder it now. so, sanjay, i know there's been much done about these companies and how they have such horrible names for all of their products. but i -- in all -- in all seriousness, i remember at the beginning there was this whole well someone will get a pill from for this and it will be fine. it's miraculous that something could be on the horizon at this point but how significant is it? >> all we are hearing from so far is the company. and i have no reason to doubt this but this has to be validated. and then, we also have to look at safety data. it's -- it's a -- it's a type of medication that basically decreases the way that the virus actually replicates within the body. so we got to make sure it's safe for all the other cells in the body, as well. again, no reason to suggest t

you could see an eua made by merck to the fda five days, two pills a day and again, it's for those thatrate -- you need to take it early. previous trial indicated it's not helpful in a hospital situation. where this drug has had efficacy is in the early days of covid. you show symptoms, you take it, it decreases markedly your ability to be infectious as well stops the spread and you're looking at how many courses of treatment. they have the manufacturing, they have the supply chain they've been getting ready for this they're on course to have 12 million treatments ready and u.s. government said we'll pay a billion and a half for 1.7 billion doses. and there's an option to acquire more courses of treatment, should it acquire to do so and again, benefitting merck and having a negative impact on some of theother players in terms o the vaccine world or regeneron, which has an antibody effective in treating covid as well. moderna down almost 13%. earlier this morning, i had an opportunity to speak to doctors, founders and leaders of a comp an that actually licensed or took the drug from emer

the government is expected to order some 1.7 million courses of the drug if the eua is granted. shoulder, they developed a drug cocktail that's very effective. the government has just ordered another 1.4 million doses of that. they already have 3 million that they've ordered. so you can see there's a lot of demand. now, all of this is coming as local, state and federal officials are talking a lot about vaccine mandates, but it's becoming increasingly clear that therapeutics need to be part of the equation. well, that's at least what one regeneron scientist told us. listen. >> i think we learned a very important lesson with now delta showing us that vaccines, which undo you wantedly are absolutely -- undo you wantedly are absolutely critical, they do not protect everyone, and some individuals are still at risk of severe outcome. you cannot substitute a therapeutic for a vaccine, but you can also not dispense with therapeutics. >> reporter: so hhs spokesman telling us that they are shipping twice as much of the monoclonal antibody treatment in september as they did in august, so t

pfizer does not plan to produce any product with these new version over the next few months while the eua authorized products still available. it doesn't sound like comernity is still going to be available. are we going to mandate and force members of the military to take a vaccine not fully fda approved? have you secured enough product of the comernity to utilize in the forced vaccination program? >> senator, i believe the answer is yes we have sufficient holdings of the approved vaccination. but i will double check on that and circle back to your staff. i believe that is the case. >> okay. i would definitely appreciate that. a quick followup what are you going to do with members of the coast guard that refuse to take the vaccine? what is your procedure? >> senator, what we're trying to do right now is drive folks toward understanding the benefits of the vaccine, the risk to force from a readiness standpoint, education. we've had folks come in and want to see the vials. we bring them in and show them the vials and make the chief of medical staff available to answer questions. we are abou

merck and its partner ridgeback announcing the submission of an eua for the oral covid 1 treatment. could be ready for americans by late this year, and pill is the operative term with the regeneron, you have to feel you're ill, get test, got to the hospital and get it infused. this, you just take a pill >>> southwest airlines cancelling more than 1800 flights, citing bad weather, air traffic control issues, and staff shortages. it disputed speculation that the cancellations was due to pilot and employees protests of the vaccine mandate. i don't know, though we'll see. where there's smoke there's fire, usually, but the union denies it. we'll talk more about it later this hour. >>> apple has asked a judge to delay changes to the app store the changes stem from the cases involving epic games, scheduled to go in december. apple is asking its appeal to be played out >> nice try, nice tries, it's only 8:04:34 >> man. >> good thing we have other things to talk about, too. mike santoli, again, yields are climbing that's generally good news what do you think this time around >> probably will

. >> probably worth pointing out to people it has not been approved by the fda yet for eua, emergency's available. great news overall for getting covid under control. >> remember the regeneron trip is amazing right now but that is considered to be obviously laborious versus the pill our country likes pims, not drips. david faber has been concentrating on this forever. again merck has way under performed. if you bought merck and came in, it's a very good company with a very good balance sheet. it has under performed like a lot of other drug stocks, including bristol. the game is very excited because we do have an interview, david is right here. we have an interview with the people really doing. it's a phenomenal company that did it it doesn't matter, pfizer we can say never did it pfizer is the one that gets credit so what matters to us is it seems like it really does work that is very exciting. >> it is, hey, jim, i know this is a big day for you we got the announcement of the cnbc investing club. we talked about it earlier i know you will talk more of this i don't want to steal your

when you look at when the eua is expected the first week of november, it comes weeks before the thanksgiving holiday rush. what we saw this last month was september was one of the worst months for children and covid. the white house wanting people to take this seriously, to get their kids vaccinated as soon as possible before the holiday rush. >> yeah, that would make a big difference. >> it would. thank you so much, heidi. greatly appreciate your reporting. we thank you so much. mika, when there are people who in the past asked, shouldn't have asked it, but wait a second, why should kids get vaccinated if kids don't get it as much? of course this is silly. >> especially the delta, they do. >> why do we vaccinate children for polio and all the other vaccines they get before going to school? you want to do it and make it as widespread to provide as much protection as possible. but in this case, you and i have a family member who had a granddaughter go to party. came back from that birthday party and gave her mother, father, grandmother, grandfather, and a grandparent on the other side, gave t

an eua is not necessary. in closing, all eyes are on you. if there is any hesitation in a committee member's mind about this vote, then at the very least, you should state for the record that you do not believe an eua should lead to mandates. our kids are not for sale. leave parenting to parents. thank you for your consideration. >> thank you for the comment. next speaker is luke yamaguchi. >> hello, my name is luke yamaguchi. i have no financial conflicts of interest to disclose. from march to october of last year, children 5 to 14 years old had a 1 in a million chance of dying with covid-19 in the united states. for perspective, children in this age group were about ten times more likely to die from suicide than covid-19. a recent article in "the new york times" cited data showing unvaccinated 5 to 11-year-old children are actually at less risk of hospitalization from covid-19 than fully vaccinated older adults. for children 5 to 11 years old, the weekly rate of covid-19 associated hospitalization has ranged from zero to a peak of 1.1 per