fda concurred with both. the globalization of drug manufacturing recent fda with new challenges many of which have been exasperated by the pandemic. while the agency has taken steps to adapt, further action will be needed to ensure it can continue to fulfill its oversight responsibilities in the future. thank you, chairman bishop, ranking member fortenberry, and members of the subcommittee for holding this important hearing. this concludes my prepared remarks and i'm happy to respond any questions you may have. >> the hearing will start at the order of seniority. after that i will recognize members who were not present at the time the hearing was called to order. each member will have five minutes in each round to please be mindful of your time. at this time i will yield to myself for the first round of questions. i tell you what, i will defer my questions to the chair of the full committee, ms. delauro, and i will follow mr. fortenberry who will follow ms. delauro. >> hanky very, very much mr. chairman. and

but they do the fda and how will fda prioritize this additional funding it. janet: certainly, overslept me say this is a huge priority for me personally. and i believe that we really need to get the clinical trial infrastructure out into the communities that wherever a senate is located, they have a chance to be in a cancer trial they have cancer, they have als, the object to be in an als trial. and as far as what we have done, as you recall, a decade ago, it was women in clinical trials people were very concerned. we been publishing on the snapshots programs and currently this past five years, women have been the majority participants in clinical trials. that's probably how it should be because women it need healthcare more. and as far as minority populations though, we are not doing very well. and much more needs to be done. the office of minority health and health equities focus on this issue of getting more diverse enrollment in clinical trials. i have been working with the director because it also is a really an issue that is very important to me. so the

before joining the fda, dr. califf was a professor of medicine and vice chancellor for clinical and transitional research at duke university in durham, north carolina. position of director of transitional medical institute and director of clinical research institute. he's also worked to move the promising field of transitional science forward as the director of the clinical trials transformation initiative. dr. califf currently is the head of clinical policy and strategy for verify life science and google health at alphabet, google's parent company. his experience also includes serving as vice chancellor for health data science and director of duke fortune and donald f. fortune m.d. professor of cardiology at the duke university school of medicine. dr. califf's unique perspective as fda commissioner coupled with his understand partnerships of the private sector and academia that assist in fuelling innovation will be vital if kwmpld as the next fda commissioner. dr. califf thank you for being here to answer quest

to the fda, i would say this. no matter what your decision is on juul's pmt i, you know the problem doesn't end there. two and the use they think epidemic, you would have to deny applications for all products with the same characteristics that made juul so popular with the generation of children because we watched in real time whenever popular flavor is removed from the market, other flavored high nicotine products take their place. i safe to acting commissioner what crops, i believe you want to do the right thing, you want to keep nicotine out of the hands of children. when you decided to ban mental cigarettes, who took a strong action to strengthen public health and racial equity. when this committee exposed toxic heavy metals and vaping foods, you make that a priority created closer to zero initiative and we are appreciative.n however, now fda has the opportunity to step up and finish the fight against youth vaping epidemic. don't let any flavored products from any e-cigarette companies stay on the market, not

by the fda. thank you. >> juul dominates the pre-filled pod market and ibts growth in market share has driven the rise in youth vaping rates. yet juul's pmta application proposes lifting marketing restrictions after just one year even though juul is currently on trial for marketing addictive and harmful products to children. juul has proven untrustworthy to continue selling its products and greatly contributed to the epidemic that we face today. so madam secretary, is the fda considering allowing juul products to be marketed again or has it made a decision to ban that practice or continue to ban that practice? >> those products are subject to a marketing application something newly introduced in to the market would have to go through the review process, as i understand it. >> has that happened yet? >> well, again, i can't discuss any single action that we might take. >> all right. thank you. >> if an application cannot prove with scientific evidence that the product will not contribute to or incr

gao has included the fda on the high risk series since 2091 of the main problems fda gives foreign drug manufacturers but not american ones advance notice of inspections 12 weeks of advanced notice and i and they will fabricate that or secretly repeat test before the fda inspectors arrive. by contrast investigators have find evidence that they could not hide important records tossed in the trash bin birds or insect infestations even urine puddles on the floor clearly that is not a safer sterile manufacturing area. these shoddy practices resulting drugs with unimproved ingredients toxic impurities dangerous particulates making their way into american medicine cabinets in 2007 and 2008 hundreds of americans died from contaminated heparin and anticoagulant drug manufactured overseas and in 2018 andnd 2019, dozens of blood pressure drugs were recalled because it contained more than 200 times the acceptable limit of a known carcinogen because of the pandemic the fda has stopped all overseas inspections and unfortunately this means the fda work to prevent potentially tainted drugs from enteri

the fda can lead the way. it needs to work, as we mentioned, with senator romney in conjunction with the nih. >> absolutely. we're seeing a crisis now and i think covid has already exaggerated what already existed. trrs but as you say the misinformation that's out there in social media and the regular media as well. around not just prescription drugs, per se, but the fda's role and i think there's -- we discussed a number of the movie treatments and television episodes around obviously the opioids and the issues there with the sackler family have been well covered. but it's larger question of mistrust between fda employees going in and working for the large pharmaceutical companies and back and forth. how do you go about rebuilding people's trust in the system? >> well, you know, trust once lost is hard to regain. that's an old statement and i think it's true. we're going to have to be much more aggressively out going and work on every single aspect of transparency we can. again, if confirmed, i do think, as a

the fda inspections. but there are significant deficiencies that give the inspection regime a c-grade. we talked about implementing new ways to augment the inspection regime such as virtual inspections. then the question becomes, are our drugs virtually safe? so we need to be careful about such matters. we also have highlighted, and i think dr. harris did a very god job with this, that we have an uncompetitive playing field. state-owned enterprises enter into partnership with american companies or other companies, that's a state-owned enterprise subsidized by the government. and again, we've had lax environmental and labor standards around the world that have resulted in incentives for american and other foreign-based companies to enter into places in the world that's hard to inspect. and this is the reality of where we are. so, again, i want to highlight the importance of the possibility of the grade for companies and give one other comment. a long time ago, i used to be on the city council where i live.

fda. she appeared before a senate appropriations subcommittee to answer questions about covid-19, new drugo research, and agencies new drug approval process. this is and hour and ten minute. [inaudible conversations] [inaudible conversations] [inaudible conversations] >> good morning. i want to welcome everyone to our first budget hearing of the subcommittee for fiscalud year 2022. and, dr. woodcock, thank you so much for being here this morning.g. we are looking forward to your testament and having a good discussion about the needs of the fda. the responsibilities at the fda are vast and have an impact on every american. that's been made even more clear during our response to covid-19. we must continue to invest in safer drugs, safer medical devices and the safest food supply in the world. and for now and for the future. dr. woodcock, i'm looking forward to hearing your visions for theou fda and what this committee can do to support your vital work. that works begin now with the fiscal ye

. >> the acting head of the fda dr. janet woodcock testified about president biden's 2022 budget request before senate appropriations subcommittee. wisconsin senator tammy baldwin chairs the hearing. [inaudible conversations] [inaudible conversations] [inaudible conversations] >> good morning. i want to welcome everyone to our first budget hearing of this subcommittee for fiscal year 2022, and dr. woodcock. thank you so much for being here this morning. we are looking forward to your testimony and having a good discussion about the needs of the fda. the responsibilities of the fda are vast and have impact on every american. that's been made even clearer during our response to covid-19. we must continue to invest in safer drugs, safer medical devices and the safest food supply in the world. and for now and for the future. dr. woodcock, i'm looking forward to hearing your visions for the fda and what this committee can do to support your vital work. at work begins now with the fiscal year 2022 budget request that's in fro

we presented evidence from our investigation to fda and fda agreed that juul was breaking the law. it sent juul a warning letter regarding its marketing practices and declared them illegal. now juul's fate is again in your hands at the fda. juul's products and all e-cigarettes need fda's approval for their products to stay on the market through what's called the premarket tobacco application process, also known as the pmta process. fda's decisions are due by september. juul's marketing to children was simply unacceptable. the attorney general of north carolina is taking juul to trial over that as we speak, but beyond marketing juul hooked kids for three other reasons, first, kids were attracted to the flavors juul cigarettes came in. second, kids got hooked because juul came in nicotine levels much higher than anything else on the market. and third, juuls were easy to conceal from adults. companies copied juul's model. when you look at the list of products that are on -- that are the subject of pmta applications, there are many, many even now in kid-friendly flavors. there are many

fda must keep pace with this. with that in mind, our budget request focuses on investments r in three main categories to ir support our modernization.cy the first is the critical public health infrastructure. the agency's infrastructure is fundamental to every aspect of our work and our budget requests a total of $185 million to support it. we will invest this funding in a several areas, including data modernization, maintenance repairs to our facility, and expanded laboratory safety efforts. i want to take a moment to ti discuss our data modernization requests in greater detail. while some may not consider this data modernization as exciting as vaccine development or food d safety science, i cannot overstate how critical it is to our success as an agency.uc we are requesting $76 million to support much-needed data modernization efforts and as we saw firsthand during the pandemic, technological advances have and will continue to vovo revolutionize human and animal health. scientific breakthroughs have enabled the

fda to my letters. i fear they are going to once again overvalue the unproven potential benefit of cessation for adult smokers while undervaluing the clear evidence of what's happening to our kids. only 4% of it up i don't use e cigarettes. 20% of high school students, kids who never would have picked up a tobacco product are vaping. it's simple, any product for the history of increasing youth use must be rejected by the food and drug administration,nc especialy flavored products we know hooks kids. this is a super bowl for the fda's tobacco effort. i'm afraid they're not ready for prime time. i hope they prove me time wrongd if announced plans to advance menthol cigarettes, important. i want to commend acting commissioner sitting behind me when she called mean with the news. just like a that, the time is nt for fda to take action and how it applies to public health standards and e cigarettes. we know fda after-the-fact enforcement warning letters in the game of lacrimal doesn't work. to put it bluntly,

another failure by the fda. now we approach one of the biggest milestones in the tobacco regulation history and the agency is going to fail again. after years t of delay by the administrations of both parties, under court order they finally required the tobacco manufacturers to submit applications from the products on september 9th, 2020. this is the long-awaited opportunity for the fda to apply a public health standard that congress passed as long-ago as 2009 and the tobacco control act to evaluate whether a product can stay on the market and whether it is, quote, appropriate for the protection of public health. that is the high bar. it requires them to balance the risk of the youth initiation with potential benefit. the burden is on the manufacturer. to show the products do not harm the user and to show they actually help adults quit smoking. remember the claim made over and over again, prove it. they can't. they know they can't. once again, overvalued while undervaluing the evidence of what's happening to our

fda can build. on the steps it's taken so far by prohibiting the sale of remaining favorite products, capping nicotine level in e-cigarettes, and pulling illegal product like those solved by puff barr off the market. i strongly urge the agency to take these common sense steps. let me conclude by commanding the leadership of chairman krishnamoorthi and the subcommittee on economic and consumer policy. the subcommittee's investigation has brought to light the dangerous practices of e-cigarette manufacturers across the country and it has underscored the urgent need for the federal government to act on america's youth vaping epidemic. thank you for your leadership, chairman krishnamoorthi. i look forward to hearing the testimony from or of our distinguished witnesses today, and i yield back. thank you. >> thank you chairwoman maloney, and thank you for your distinguished leadership. thank you for your opening statement. now i would like to begin by introducing our first panelist, someone i know very wel

another failure by the fda. now we approach one of the biggest milestones in history and i worry the agency is going to fail again, after years of delay by an administration of la courtties the fda under order, under court order finall- required e-cigarette tobacco manufacturers to submit applications for vaping products on september 9, 2020, this is the long-awaited opportunity for the fda to apply a public-health standard that congress passed long ago in 2009 in the tobacco control act to evaluate whether product can stand the market and whether it's appropriate for the protection of public health, that is a high bar and f requirs the fda with the risk of youth initiation with potential benefit bottles and the burden is on the manufacture to show their products will not lead to use and show their products too not harm the user ensure that they actually help adults quit smoking, remember that claim made over and over again, prove it, they cannot, they know they cannot i'm deeply troubled from the response of th

most assume it is fda approval we may never have fda approval on any vaccine especially but the ongoing phase three clinical trials. and we are learning as we go in the real world. it seems eua is the new standard with variance popping up there will be an endless market for endless booster shots. and at the public giving true consent that they investigational and may not stop transition has not impacted on with those immune deficiency now we see celebrity politician from answers joining in on the mass vaccination ever telling the public the shots are safe. how do we know these adverse events are taken seriously? so we have seen in the shortn st term are being dismissed and accepted as the vaccine is working as priming the immune system. they take the proper reporting measures to the fda and cdc to this day none of them have been contacted or followed up by the companies. weeker earlier this first months of shots of no safety issues with pfizer or the teethree vaccine. we haven't seen immune system fertility or other health issues ultimately the real world clinical trial it is one big hu

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

as soon as the vaccine is authorized by the fda. so the first step in the process, that's when we will begin to ship pending the cdcs -- cdc's decision. we'll ship about 15 million doses out nationwide in those next few days with millions more going out each and every week to make sure that we're matching the doses with where they're most needed, where there's the greatest demand. so to put the first week's allocation in perspective, the 15 million going out all in that first week, it took 12 weeks back at the end of 2020 and into 2021, it took 12 weeks to get enough supply out into the field to vaccinate half of the eligible adult population. so we will be doing all of that upfront with millions of more doses each week. so we're in very, very good shape here. so the bottom line is there will be plenty of supply and we look forward to parents having the opportunity to vaccinate their kids pending the fda and cdc decision-making. dr. fauci on jeremy's second question. dr. fauci: yeah, jeremy, you bring up a good point. you know, mont

full fda approval could occur within a few days. this would be the third coronavirus vaccine approved by the fda. the johnson & johnson vaccine can be given as a single dose. with the biden administration now leading the federal response to the coronavirus pandemic, follow the latest at cspan.org/coronavirus printed search cspan's coverage of news conferences as well as remarks from members of congress. use the interactive gallery to follow the cases in the u.s. and worldwide. thirty cspan.org/coronavirus rated and trent. tuesday fbi director christopher wright testifies before the senate do just a rere committee regarding the fbi security and planning in advance of entering the attack on the capitol on january 6th. watch our live coverage at 10:0n three. also cspan.org or listen live on the c-span radio app. while in texas yesterday president biden's coronavirus vaccinations site as the stadium

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

and families have faced turmoil and tragedy and we see the extraordinary encourage and resolve, the fda has been at the center of the government's efforts with the public up emergency and it is staged professional personal challenges. we have worked hard to meet these challenges with unprecedented scientific effort and diligence. the agency workload increased significantly to methinks ordinary demand of covid-19 on the order of approximately doubling our normal work in our workforce responded in kind taking on the new challenges walk continuing to fulfill our regular mission critical responsibility, i would like to address aspects of this commitment and i'll start by giving you a small sampling of our non-covid related achievements from the past year, our foods team worked diligently to address food supplies during the crisis and to support employers inc. covid industries to resume safely and we all know food security is national security and the significant component to that, at the same time the career staff also advanced initiatives related to food safety generally in july we announc

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.

why the fda goes line by line. we aren't just going to rely the number provided to us by sponsor in what we want to do is look at the data from one large randomized trial and we are going to look at those data into our own number crunching and make sure we are confident that whatever numbers is boris efficacy and safety comes of the trail we are confident that the data represent separate in general that's what it v-8 does and we will absolutely stick with that during my tenure and after that i have confidence the agency will do so. >> one last quick question from matthew. >> dr. de leon six thank you for taking questions. for many months you've emphasized the importance of datata in science and fda decisions and it's clear you've worked veryy i hard to make sure that's the case but over the years there have been proposals for ways to insulate the fda from those political forces making a a separate agency outse of hhs into a fixed term. as you near the end of your tenure and reflecting on your time on the job do you

at the same time, obviously defer to the science and the the fda. and i think we learned that lesson, as i said earlier from the prior administration where the decision was made by the fda and cdc and the operations weren't ready. and that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. and this will enable us to be ready for kids. on vaccinations for kids and requirements, first i'll just start by that's really about schools and vaccinations and practicing, as dr. walensky said, proven health measures including masking, distancing, and ventilation is the best way to keep scho have been around for decad at the state and local level. we know that in general requirements work and we support states and school districts taking actions to ensure that vaccinated. but again, those decisions should be made at the state and local level. one more question, kevin. dr. murthy: [crosstalk] can i actually add one thing to your last comment? mr. zients: please. dr. murthy: so cheryl, to your question, i'

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

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

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

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

the fda and cdc are pouring through the data. this is what europe was criticized for, and abundance of caution around a small number of cases in the context of a large number of vaccinations that have taken place. same question will be asked to the fda and the cdc as well. tom: i've got the number here. it is essentially meaningless. it is 0.000000882%, and sam fazeli said astrazeneca is at a much worse one and 100,000. jonathan: jack, have we heard from the administration yet? do we expect to see anything this morning? when can we expect to hear from the white house on some important developments around the vaccine effort in america? jack: there hasn't been enough time to get much of a reaction out of washington, let alone the white house specifically. this does seem like the kind of thing we could hear a reaction to relatively soon. i would look for responses to how this affects the timeline, and immediate response out of washington this morning, but it will probably be a cautious response because so much of it hinges on what f

today we are talkingng about fda and cdc's advisory committees. a senior writer with staff use here to talk about these two advisory committees, let's begin with the fda. what is there advisory committee? >> the advisory committee helps them on issues related to the approval of vaccinations, vaccines vaccines and related biological products advisory committee, mostly people -- [inaudible] >> they are set to meet this week. what are they expected to talk about? >> you remember when the fdada s under political pressure to fast-track the vaccines and then commissioner stephen was trying verywa hard to safeguard the process to approve vaccines, make sure they were based on science, not political expediency, made the commitment that it would reach every time there's a new covered vaccine to be considered for emergency use authorization. since then, he's kept that promise every time, he's no longer in office but the fda has kept that promise everyy time a new covered vaccine is ready by fda to continue to consider whether or not tode issue emergency use

and then urge the fda to approve today. two, urge fda to approve medicine for the subgroup today. three. and that expands access today. impasse the promising act to have rapidly progressing fatal diseases even beyond als. spent tens of thousands of patients are watching this from their homes wheelchair-bound some on life support, watching this today. there hope this in this hearing. some have waited and postponed their decision for suicide to see this hearing. i don't thank you understand what this hearing means to us. please do not let another generation of als patients die in pursuit of the purpose. please let this be the first generation to survive we want to live. you have the power to make it possible. thank you. >> i think there is applies from the entire als community offering your testimony. we are so in debt to you thank you for your clarity and your courage thank you for the patients you have exhibited today and i don't think that every single member of the subcommittee is moved by what you said and that we are determined to pursue exactly what you set out to do in your

most assume it means fda approval. we may never have fda approval onany of these vaccines , especially related to placebo-controlled roots on the ongoing phase 3 clinical trials. these vaccines need to continually be framed as investigational and we are learning as we go in the real world. with all the risks that entails. it seems eua has become the new standard with new variants popping up there will be an endless market for potential leadership. work speed testing, then deploy and hopefor the best seems to be the new accessible strategy . is the public being given true informed consent and made aware of these vaccines are still investigational and may not transmission , may not stop there life, have not been tested on all people like those with immune deficiencies and pregnancy and now we are seeing politicians and influencers joining in on the mass vaccination efforts while telling the public the shots to take. how can the public be assured harmed adverse events are being taken seriously western mark the adverse eve

was it the fda, were all the fda processes followed, or has that been resolved? >> so the contamination event was identified through our quality control procedures and checks and balances. when we were informed and made aware that the contamination occurred, as we always do, we opened up an investigation to determine the root cause of that contamination event, that information was shared with the fda as soon as the investigation report was completed in early april. >> so you followed those fda processes. did any of the contaminated doses get out of your facility? were any put in the arms of people or was this internal discovery that stayed internal? >> importantly ranking member scalise, our internal quality control procedures identified the specification in the contamination. none of that material left our control. the production lot was quarantined, set aside, and never left our facility. >> and i know we're going to have a second round of questions. i do want to get into this, though. i understand there are some batches that were made that were not contaminate

>> the fda, thanks for the question first. the fda authorization was the trigger that would allow -- that allowed for the beginning of the packing and shipping process and that started immediately within minutes of the fda decision. people have been working 20 47. we expect that several million doses are in route to sites around the country. across the next week or so, 15 million doses will be around the country at convenient and trusted sites. that is why we are planning on some vaccinations toward the end of this week. the program for kids ages five to 11, really hitting full strength of the week of november 8. next question, please. >> thanks. on kids, i'm wondering if you can tell us your thoughts about the need for younger kids. we asked the fda about this on friday and dr. marks suggested it would be a few months off, mainly because of the kids in the trial. but also the risk benefit is different, there is less risk of severe disease. i am wondering about the sense of urgency for vaccination among kids under five. >> dr.

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

i think it's important that we have here the fda and fda is the gold standard for ensuring the safety and effectiveness of the vaccines and today's action i think is clear evidence that they're taking every step necessary to ensure the american people have clear and transparent information about the safety and effectiveness of these vaccines. so the bottom line is the vaccines, moderna and pfizer that are now being administered, are clearly safe and are saving lives and every american should get vaccinated when it's their turn. >> thank you. jeff, is j&j production going to continue during this pause? and secondly, is the biden administration considering ordering more doses of pfizer and moderna, given -- just in case this problem with j&j becomes prolonged? >> so the j&j production issues in baltimore, obviously, are a completely separate set of issues and those are being worked out through the fda process with the company, the production of those vaccines can begin if and when the fda authorizes that. the second question was, we really have thought of this as a war-time effort from