meeting will come to order today we're having a joint hearing of the health subcommittee and the oversight and investigation subcommittee and the hearing is titled h one n one preparedness and update  vaccine production and distribution we're going to begin with opening statements from the members of the subcommittee the chairman and ranking members of the two subcommittees will be recognized for a five minute opening statement followed by a five minute statements by the chairman and ranking member of the full committee and the chairman emeritus other members of the subcommittee will then be recognized for two minutes opening statement and i'm going to begin by recognizing myself and let me explain that the purpose of this hearing is to get an update from the main stakeholders involved in the manufacturing and distribution of the h one n one vaccine and to shed some light on where we currently are in the process and what we can expect moving forward  recent estimates from the centers for disease control are truly alarming over the past six months it is likely that twenty two million people in our country have been infected with the disease and about ninety eight thousand have been hospitalized to date it is estimated t thirty nine hundred individuals have lost their lives to h one n one unlike regular flu that affects predominantly the elderly population the vast majority of h one n one deaths have occurred in people between the ages of eighteen to sixty four even more tragically the c d c estimates that five hundred forty of these deaths have occurred in children and these numbers are significantly higher than earlier estimates and as we move further into flu season we can only expect to see them increase even more we now know that this virus and vaccine is unlike move x means that we've produced before and that it is extremely difficult to grow early estimates on vaccine amounts were based on how vaccines usually behave in the production phase to anyone involved in this process h one n one flu to be very different and though the manufacturers have been able to speed the growth of the vaccine by selecting the fastest growing strain we still are lagging behind where we originally thought we would be with our production numbers fortunately though this particular vaccine appears to be highly effective in creating an immune response in individuals and for adults one small doses of vaccine will produce enough of a response to protect from h one n one but these early delays in production are now rearing their ugly head as our country watches the disease spread and take flies while vaccine is still hard to come by to date nearly forty two million doses are available distribution which is about half of what we originally expected to have by this time it's no wonder therefore that story after story in the papers and on the news highlight the frustration that the american people are facing in trying to get a vaccine that would protect them from the disease we hear accounts of individuals waiting on lines for hours at clinics some cannot find clinics in their neighborhood at all areas are still waiting to receive even their first doses of the vaccine there's a school district in my hometown for example that is yet to receive the vaccine and understandably the parents are irritated and this frustrating is exacerbated by accounts in the country that seem to have more than enough to get vaccines you know in some areas we're getting this vital production from h one n one poses no difficulty at all so we're getting a lot of disparities from one place to the next and naturally people are confused and they're angry so that's why myself and chairman stu packer holding this hearing today i personally would like to better understand how the production of vaccine is going when for example we'll be able to expect enough vaccine so that all individuals who want to can get it and will this happen before flu season is over but also like to understand more about the distribution process and a stance of the states make their own distribution plans and do the ordering for their states through the c d c but how are these plans created and how does states make a determination where to start with vaccine distribution and which just just tribute to prioritise we have a number of very important individuals with us today who've been working around the clock on these issues and i'd like to welcome you all we appreciate your taking the time to provide us with this update today we understand how difficult this process has been you know we're not here to beat you up but we're here to try to get some answers and particularly where we go from here so what that i'd like to let me just thank you again bart stupak chairmans to pack for working with me to put this hearing together and i guess we're going to go to mr walden at this point for an opening statement well thank you very much mr chairman thank you for convening this important hearing h one n one has been dominating the news and parents and general public's concern for the last couple of months as we all know i'm hopeful this joint subcommittee hearing can help answer questions and discuss solutions to the challenges arising from the first flu pandemic in forty years as many of you know i have first hand experience with h one n one i think i was probably the first member of congress to go on record as likely  having been diagnosed as having h one n one i'd not been vaccinated because like the majority of my fellow members of congress i don't fall into the priority groups and like millions of other people across the country i've had one and one i felt rotten for a few days it's not something you want and it's not something you want to pass on to others but i did follow my doctor's advice and directions and stayed at home arrest for at least two days after  fact that this flu hit young children so hard in the constant news reports about rising pediatric deaths the daylights out of parents played out in the number of parents lining up with their small children in public vaccination clinics for hours at a being able to vaccinate their children by october or november originally projected forty million doses would be ready by the end of october ultimately only twenty three million doses were available instead parents hear reports every day on the also want to hear from h h s and the vaccine manufacturers about the reasons for the delay and what can be done now and in the future h h s secretary sebelius was before the full energy and commerce committee on september fifteenth and at that time she testified that by mid october a quote large scale campaign close quote for vaccinations would be underway she also stated repeatedly that there would be and i quote enough for everyone close quote secretary sebelius now says the vaccine manufacturers painted an overly rosy picture of their production is that or did the virus not perform as expected i don't think fingerpointing exercises are particularly helpful at a time when we're facing one of the biggest public health issues in recent years and a somewhat panicked public but there have been reppert no doubt about it i also want to learn about how h h s has assisted state and local health departments in preparing for this pandemic for example in my district hospitals are implementing their incident command plans to do emergency rooms being hit with waves of patients with flu like symptoms patients are coming at a time when doctors nurses and hospital staff are either home sick with the flu or taking their children that are home from school because of the flu so we're looking to a shot of increased patient volume and decrease staff capacity hospital administrators are monitoring staff levels and patients volumes in some cases on an hourly basis if they reach a tipping point the hospitals can cancel elective surgeries to ensure there's adequate staffing to care for patients in the emergency room and those admitted to the hospital when i called the eighteen hospitals in my district  one of them asked where's the vaccine that we were told was coming so let's get the facts on the table about the reasons for the delay and when h h s knew about it if there were production issues how can they be corrected and if there are this isn't the last hearing we have on this issue this is the first pandemic in forty years and the first since congress began providing funding in two thousand and six for pandemic preparedness and at that time we were deeply concerned about the possibility of a pandemic spreading a bird flu that could be in mortality fortunately this one has not proven to be as i believe congress has appropriated thirteen billion for this effort this is an area where we need continued oversight so we can figure out what worked what didn't and what we should do going forward so i'm particularly interested in the technologies for vaccine production and whether we can do better in the future i understand that one of the manufacturers mehta muniz been able to meet its delivery schedule in part due to the different kind of technology that company uses to make a live attenuated even though madam grows the virus in chicken eggs which is uncertain and unpredictable and yielding a sufficient supply they have better results i know that is part of it pandemic preparedness plan and h h s has awarded contracts to companies to look into production as well as other ways to improve production time so i'd like to know about the status of these efforts and whether we're doing enough to ensure that we're work with me in our own staff for putting together this hearing look forward to doing this joint hearing today and i think we have a good hearing lined up and as you say we're not here to try to find out how we can do things better and today we continue our committee's oversight of the two thousand  people have been hospitalized in michigan with flu like symptoms thirty thirty five percent increase over last week when eight hundred one cases were reported the oversight investigation subcommittee along with the health subcommittee have a responsibility not to rely by joining the manufacturers is dr david lakey commissioner of the texas department of state health services who will be the voice of the state health departments across the country and dr jeffrey leaves the executive director of distribution process number two why have there been productions specifically why and why has there been difficulty in growing the virus is it because  technology is because of process is it something else and then third of all i would like to touch on how does the u s compare in getting this vaccine out with other countries ak for holding this joint subcommittee hearings on the h one n one virus and how we're responding to it the reports on h one n one are so varying as of last week forty six states are now battling the disease c d c estimates that perhaps twenty two million people have been infected with h one n one and as many as ninety eight thousand have been hospitalized and about four thousand have died including five hundred forty children this is a harsh reminder that we don't need a bioterror attack or other man made disaster to threaten our health and make us worry for our children in several ways we have been well prepared the federal and pandemic for several years our surveillance worked and we were able to catch the h one n one relatively early and it spread federal and state governments have developed an exercise pandemic plans public education has been commendable there are five safe and effective f d a approved h one n one flu vaccines now available and that has the authority for a merge fighting but there are clear gaps in our preparedness we had widespread disease before we had vaccine and vaccine supplies have been more limited than we had hoped and at the same time hospitals and other health care providers have been stretched to capacity we know that the best way to protect ourselves from the flu h one n one or below is to get vaccinated because of this contracted to purchase one hundred ninety five million doses of h one n one vaccine they also picked up the full cost of the states for purchasing the vaccine the hope was that a robust vaccine supply w before inspections began to soar and everyone worked as quickly as possible to meet that goal these hopes were not met the past several weeks have reminded us that the process of making flu vaccines is unpredictable and challenging millions of chicken eggs have to be injected with virus and the virus has to grow unfortunately this virus initially grew much more slowly than anticipated and this lag is caused most caused most of the delay in producing delivering needed supplies there's understandable frustration in the face of a growing number of infections and long lines at vaccination clinics parents are understandably concerned about getting their children immunized as quickly as possible i want to make sure that everyone who needs the vaccine has access to it at the same time there have been unprecedented levels of collaboration among federal agencies the vaccine manufacturers and the states and according to experts the manufacturers ability to produce a vaccine within six months after a dentist buying the virus is impressive these efforts while significant are not enough for those people who are still seeking i look forward to the day's testimony so that we can understand where we are in the epidemic and the vaccination effort we also need to learn how the process can be improved  sincere prayers for those who have lost family and loved ones during during this illness and there throughout the country and and i think a lot of districts have been affected information has been good  as more people washing their hands more people covering their mouths greg walden mentioned staying at home and i think that that is a thing that information has been very very helpful information is also been harmful and  projection of information to the public because the public will respond appropriately i think the rosy expectations has really caused this dilemma that we're just the other thing that i think we should focus on is this is something that we've had a year to prepare for what is in our first pandemic after september eleventh is there is something that we cannot prepare for we do not you chairman like so many other members of congress day afternoon of april football game was interrupted with a notice of a public health emergency about a new we had a conference call later that day for members of congress i don't know how many were actually on the call but i remember thinking at that time our greatest danger here is not anticipating how aggressive this virus could be if we are truly faced with a novel influenza for which most of us do not have  preexisting immunity and that's sort of where we are today fortunately the story is not nearly as bad as it could have been and many of us feared that it might be but nonetheless it points up some of the difficulties that have been encountered mr possible pandemic than we had after we find ourselves in the throes of this illness now we do have to ask ourselves how could we have missed anticipated the ability to produce vaccine we saw this coming we knew it was coming we had reports over the summer from the southern hemisphere that it wasn't as bad as it could have been and yet there were some particularly vulnerable populations which would need perhaps aggressive use of vaccination protocols and we found ourselves in our district without being able to provide even the vaccinations for those high risk individuals in fairness i do want to say that i've had good cooperation from  the department of homeland security barbour health and human services my district in august and had a roundtable with school districts in my area so that they could be better prepared for work independent school district took a lot of heat last april and may texas department of health and he has also been good enough to do conference calls with members of the texas delegation as we work our way through some of the difficulties with the distributional issues of getting the vaccine where it's needed and i would also  october along with i'm sure probably all of my colleagues have received countless calls from constituents asking when they can get the vaccine lines of patients have been out the door the stomach reasons for this somewhat antiquated process we have today for more than half a century the united states has been a technology to create vaccine while it's safe and effective it's a slow moving process across europe developers are using the faster process of incorporating a million sales to grow vaccine as we begin to explore  technology i would pose the question will there be an adequate f d a approval process for these new vaccine but i'm also interested in hearing the vaccine manufacturers and how they ramped up production in some cases to ten times their normal production schedule we know that production has been delayed for h one n one a harmful but relatively moderate virus compared to something more lethal like the spanish flu but in the case of a stronger virus with a higher fatality rate what our country be able to produce enough vaccine for everyone is short time period so i look forward to questioning the witnesses welcome them again learning more about how we can improve vaccine production in our country and again thank the chairman joint and important here and i yield back thank you misess the gentleman from pennsylvania mr murphy mr chairman as we look at how we are handling this latest crisis in our government our reflect back on a few years ago when we were faced with the sudden  anybody else in town because the government's mismanagement of the whole issue now of course it begs the question who do we blame this time for where we are or should we stop that game and simply get down to the business of understanding we want to painfully candid and brutally honest assessment of what is happening what is gone right what has gone wrong do we have any weaknesses and what do we need to do about it i would hope it is this case instead that we use his h hearing as an opportunity to be honest with each other we are all deeply concerned of the thousands of lost lives the thousands who have been hospitalized and quite frankly the millions who are worried that they may be affected by this latest virus hitting our nation we recognize the incredible scientific achievements and quite frankly i'd like to compliment the manufacturers are working so hard in trying to develop the backs of nations and the nasal systems for sending out these things to help us deal with this virus but we still have a long way to go and we are having this hearing today quite frankly because we are concerned something is not going right was that the goals were set too high to one realistic was done somehow to assuage the worries the public but something we were not ready to do or can we really meet those goals i'm looking forward to hearing from all the witnesses say we have a very talented panel before us i'm excited to hear what you have to say but more than anything else let's use an opportunity be honest not political and we'll work for some solution and i yield back my time thank you gentleman from texas must agree thank you for holding this hearing today give us an update on h one n one vaccine production distribution texas has ordered its full allocation of three million doses of the vaccination but that orders not been filled due to the slow production and supply th chairman thank you and chairman stupak for holding this hearing is an important topic obviously and one we ought to be concerned about i've been concerned about both the vaccine distribution interested to hear the answers to those questions in missouri alone there been sixty school closings this year since the beginning of the year last year during the same period there were none since october the fourth approximately twenty one thousand seven hundred people a person died from complications with h one n one i want to know and the people i work for want to know where the problem  failure to understand the problem to recognize the problem the moon moved forward with the problem and with back delivery how long ago did we know that the vaccines were not going to be available and what we have done pennsylvania gentleman from pennsylvania mr doyle thank you mr chairman and i want to thank you for holding this hearing on the issue of h one n one preparedness at such a relevant time as the centers for disease control has recently reported the h one n one strain has now claimed over four thousand lives since april of this year of those over five hundred were children i'm very sad to report that just this past week a newborn baby died at children's hospital of pittsburgh located in my district of suspected h one n one influenza if confirmed as being an h one h one n one death this will be the first reported infant deaths in the state of pennsylvania alone ninety six hundred cases have been reported nearly eighteen hundred of them in my congressional district this is indeed a very serious problem this pandemic is different than what we're used to dealing with every fall was the target an unlikely and unusual population the strain is mostly affecting younger people with more than seventy percent of the reported cases in pennsylvania involving people under the age of twenty five antivirals are playing an increasingly important role in fighting this epidemic and i'm happy that the f d a has recognize by issuing emergency authorization for administration of these potentially lifesaving drugs i do have serious concerns about the reports of the difficulty doctors had in the training enough vaccines for their patients and i'm anxious to hear witnesses testified at this year's distribution plan for the vaccine was unprecedented and i'm extremely interested in the opinions of our panel of its effectiveness i think that this hearing will serve as an important venue to hear from all sides of this issue and help us all work together so that in the future we know what works and we know what must be improved upon i look forward to hearing from our witnesses and i want to thank you for your testimony today and again i want to thank the committee for holding this important appropriate preparations these are some of the questions we're going to want to get to today i want to talk with you about the delays and what you think is cause the communications process is where the breakdown have been between you all and h h s because we had different messages that were coming out that's confusing to the public i think also the processes that were in place for approval for distribution a then certainly looking at the diagnosis confirmation portion of that and then let's talk about lessons learned in how we move forward i had pulled a reuters article a commie you made in here where you say i think the key barrier to our immunization effort is really the fragility of the public health infrastructure i'd love to explore that with you thank you all thank you mr chairman i yield back thank you gentle california this compares favorably it is less than annual deaths that are expected from the seasonal flu i suppose that's good news but i agree with chairman waxman that this is our rehearsal for a major terror attack from some sort of biological weapon and i think our grades are very mixed in terms of preparing the public i think we do have done very well and i commend the panel and i commend others in our federal government for making the case calmly and providing lots of details for what the public is supposed to do give that an a in terms of preparing the vaccine we've had a lot of mixed results and i for having the energy and commerce committee held today on h one n one prepared over the course of this year we have seen the strain of influenza spread to a global proportion and lead to a declaration of national emergency according to the c d c as of november thirteenth two thousand and nine influenza activity was widespread in forty eight states almost all of which is likely one n one influenza furthermore there have been ninety eight hundred hospitalization twenty two million infections and thirty nine hundred deaths from the h one n one virus five hundred forty of which i've been confirmed pediatric deaths both public and private sectors have attempted to work together in an expedited effort to ensure adequate vaccine production and delivery to unfortunately such efforts have fallen short we have seen major delays in access to this much needed vaccine as a result we have thousands of individuals including those in high risk categories still waiting for the vaccine as we also deeply concerned about the impact of h one n one on our children in our schools during seasonal flu outbreaks ninety five percent of deaths are usually among those older than sixty five but for the swine flu ninety five percent of the deaths are occurring in those younger than sixty five and typically among those are younger than that my concern is that every parent who wants to get their child vaccinated should have the opportunity to do so the delays in getting the vaccine to the american people must be addressed and fixed now clearly there are problems with the current process in place that could have been that mr chairman i yield back thank you gentleman from pennsylvania mr pitts thank you mr chairman and thank you chairman stupak for convening this joint hearing i'm sure that all of us have received phone calls and e mails from parents wondering if they will be able to obtain the h one n one vaccine for their children i'm sure we've all been stopped by constituents back home wondering when the vaccine will be available in their area worried one and seasonal flu vaccine this is of great concern to me and i asked this of our secretary of health and human services when she last appeared before the committee it appears that we have five contract manufacturers for h one n one thank you mr chairman thank you for allowing this joint hearing today on the national h one n one swine flu preparations especially on the current status of the vaccine production and distribution i'm interested today in examining the lessons learned from  administration and vaccine manufacturers in terms of responding to this national public health emergency to date manufacturers have delivered forty eight million point by forty eight point five million doses of h one n one vaccine and the department of health and human services has hoped to have as many as one hundred twenty million doses by now obviously there is a large gap between the administration both the administration had promised and what they were able to coordinate and deliver i'm concerned that the administration's plan was overly optimistic and that this has led to confusion with the american public since september one eight hundred ninety oklahomans have been hospitalized due to complications from influenza and twenty seven persons have died ninety percent of the h one n one related deaths have been persons less than sixty five years old health officials in my state announced yesterday that all oklahomans who want to reduce their risk of h one n one infection are now eligible to receive h one n one influenza vaccine while vaccine supplies are limited demand from priority groups is to a point where all oklahomans can begin to receive vaccines h one n one influenza activity has been widespread in oklahoma since early september and even even throughout those statewide monitoring it as recently shown a decline in influenza lay tosca was a virus is expected to circulate throughout the winter months the possibility also exists that another surge of h one  one flu may fall the current one and we need to be prepared for this contingency i look forward to hearing the testimony of our witnesses and examining how we can continue responding to this public health emergency now you're back to  risk to combat the spread of the virus such as hand washing and the use of alcohol based sanitizers and i appreciate secretary visit to florida last week she visited the family health care center in brenton florida and we met personally with representatives from the health department community health centers and other providers throughout the area to review local distribution of the vaccine particularly to people in the high risk categories that have read something on the internet that has discouraged them from receiving the vaccine and after after talking with them i went online to see what is out there and the misinformation on the internet one website called it a complete load of nonsense that mainstream media and american public health officials state that the benefits far outweigh the risks they're our work cut out for us but it doesn't stop there in september a major cable news network did a segment with a so called infectious disease expert advising parents not to vaccinate their children and declared that he would not vaccinate his own children thank you the gentleman from illinois health thousand h one n one specific website that contains a wealth of information about vaccine availability and prevention information the city of chicago set up six free clinics to administer h one n one vaccine the college's chicago vaccinated nearly fifty one thousand people in the seven days following the opening of the clinic but there are a number of issues surrounding the infection and death rates in illinois that lack sufficient explanation maybe you have these answers why is the highest number of h one n one deaths among adults age twenty five to twenty nine all the things we previously knew about flu viruses do we have the correct distribution system is giving back to banks and companies like goldman sachs and the best way to distribute the vaccine our current lack of research data limits our ability to draw communities over six hundred twenty three hospitalizations due to the importance of this year as well as fourteen deaths our state is work with the federal government manufactures to make as many vaccines available as possible to our residents and i'm looking forward to hearing how we can better improve our strategy in coordination for responding to this public health crisis today the total of just over two hundred ninety six thousand doses and providers reported having administered just over one hundred seventy six thousand doses of the vaccine i'm working on legislation to proactively address the rising counterfeit medications my colleague mr boyer counterfeiting is a lucrative business and i hope that my colleagues will proactively work with me to address this issue any drug safety legislation to come before this committee tha in fact happening but more importantly i think it's important that we understand what we can do as a legislative body at this point to enhance our ability to manufactur distribute the vaccine in a better way we've obviously seen far too many deaths cross country certainly ohio in my congressional district has been the exception to that and also interesting air interested in hearing your  concern concerning other ways that we can combat this h one n one epidemic apart from administering the vaccine my colleague from florida reference the misinformation campaign that that seems to be occurring out there i'm curious as to educational component that that we can promote simple things like hand washing and people understand what is happening but it's also critically important that we do everything we can to affectively deal with h one n one from this point forward and frankly today for the record because i'm sure every single thing i had in there has been said by other members of the committee but let me just say this the oversight and investigation committee has had a number of hearings over the i think one of the difficult things for local school districts has been an inability to really get the best information regarding how they should approach small or larger sized outbreaks in school systems  process that have i think some real some real potential and i'm interested in whether you think any of those processes might come online this season or whether we're looking out in the next outbreak or to the next season for some of these alternative processes but again i think there are a lot of i think there are a lot of questions but i think that you've answered many of them so far i think you've done a great job in disseminating information getting information out to the public and i think that this hearing can just help you build on that back gentleman from the virgin islands miss christiansen were african american hispanic children which is considerably more than the percentage of the population i'd like to hear something about of what is being done to outreach to those communities as i have asked  represent the community around st francis prep which represents i guess the closest thing to the american ground zero for this virus you know frankly we have this is the problem of trying to deal with a complicated health thing in the context of twenty four hour news and a lot of people who look at this with a lens of their own experience we have swung wildly from pole to pole between this is an enormous problem that is going to smite us all to this is not that big a deal we have the very same people who have been traveling the country saying get government out of our health care are now saying how come government isn't doing a better job with our health care i certainly hope that you had a strong and stern talking to to those viruses that what the bottom line of all of this is to some degree we've all participated in a small way to dealing with this notion of frenzy around this even the vice president i think probably regret he would recommend his family members not get on a subway in new york city where you can catch things but i'm not sure swine flu is going to be at the top of your list the point is that to some degree and government to exaggerate our ability sometimes to be able to  be against mother nature on the laws of medicine and some degree chemistry and physics and the like and i think that you should be commended for trying to keep a low level conversation tone here even in the face of many different cross current we should try to learn each time we have one of these instances what we can do better and i to some degree a lot of what you've done now is based on lessons that have been learned but i think that and polluted with a lot of misinformation so i appreciate your being here to help us do that thank you the gentleman from georgia mr barrow i thank the chairman and with  high risk category college students but i'm very concerned about the delay in productions a vaccine and the shortages of both the h one n one and the seasonal flu vaccine in the process of vaccine distribution there have been severe shortages in my state of iowa which by the way is the number one egg production state in the country and i'd like to speak out on behalf of all eggs who've been criticized the vaccine shortages that led to the cancellation of flu shot clinics in my state iowans without access to the flu vaccine and left them vulnerable to the virus and as of last friday the i would apart in a public health confirm nine hundred eighty one n one related deaths and i'll include in one child an eighteen adults and those victims include people from dubuque and blackhawk counties both of which are in my district and more than five hundred iowans have been hospitalized with the h one n one virus that's why you can imagine how outraged i was to learn a couple of weeks ago that some of the biggest companies in new york mr wiener including goldman sachs citi group j p morgan chase and time warner were receiving large doses of this vaccine for their employees i don't think that it's appropriate or fair that big wall street firms be given priority access to the vaccine while thousands of iowans are going without it i sent a letter on november fifth to secretary sebelius expressing my serious concerns about the distribution process and urging her to ensure that the vaccine is distributed based on risk and need not based on wealth or profession or zip code i haven't received a response to my letter so i hope that you folks today can shed some light on this process what additional corrective measures if any have been taken and explain to me and my constituents why these companies were receiving the vaccine when so many of my constituents were forced to go without and i'm talking about seniors immuno compromised individuals and children i look forward to hearing the testimony the witnesses today and learning why the iowans that i represent who would like to receive these vaccines and would like to receive them soon will receive access and what is  to promote expansion of the availability of the virus thank you gone compared to where you thought they would be the last time we had a hearing at the beginning of this process you projections you talked about certain contingencies and i'm interested to know how the advance of the disease has panned out against those original projections because it helps it helps us make judgments as you project  further and that would be both with respect to dance of the disease and with respect to the way we're responding to it and i just want to echo what congressman braley just said and that is if there are going to be delays in the distribution and if what's been manufactured is less than what we hope to have at our disposal at this point in time it becomes even more critical i mean it's always critical that the distribution be done in a fair way but it becomes even more critical that it be done fairly because the larger context is that there are shortages and it makes people  much more resentful and rightly so when they when they see an unequal distribution and when that's not occurring according to the criteria that you've laid out so i think there's probably a lot of interest in having you address that that americans are asking lots and lots of questions and we're hearing that this is something that is easily spread and yet we were told several months ago that there would be adequate vaccines and there aren't and i know people have been contacting my office to find out where they can get vaccines and i think what happened here is that people's expectations were rising when the government announced that there would be no problem and people would have enough vaccines for use i think if that had not been stated or said perhaps people's expectations wouldn't be so high but the double whammy of not having enough vaccines plus the announcement that it would be enough for people has made people who have made people think that something is terribly wrong i've had some discussions with some of the people testifying today and they have helped me to understand what's happened but i think that we really need to ensure that something like this i really never happens again i know that people in my district have been wondering my my staff director had his two little boys just last week both come down with swine flu and people have been calling my office and wanting to know where they can get vaccinated and we've been trying to help them but the best we can but people are confused and angry at the same time so i look forward to the testimony to hear what the witnesses have to say and i thank you mr chairman for holding this very important hearing and i yield back thank you mr engel i believe we've concluded our opening statement so i will now proceed to the witnesses let me call or introduce the first panel starting with my left is dr anne schuchat i hope i'm pronouncing it right who's director of the national center for immunization and respiratory diseases at the centers for disease control and prevention and then we have dr nicole lurie who is the assistant secretary for preparedness and response at the department of health and human services and finally dr jessie goodman who is chief scientist and deputy commissioner for science and public health for the food and drug administration now in accordance with the policy of the oversight investigation subcommittee i have not done this before but because of the policy of the oversight investigation subcommittee all testimony at today's hearing will be taken under oath and am to advise you that you have the right under the rules of the house to be advised by counsel during your testimony and i have to ask you initially if you wish to be represented by counsel and if so you would have to state their counsel's and we'll start with the opening five minute opening statement from dr schuchat i think you all know that you can submit a longer statement for inclusion in the record but we'd like you to try to stick to the five thank you thank you chairman situation as you've heard we released new estimates for the toll the virus has taken in the first six months of the pandemic twenty two million infected or ninety eight thousand hospitalized and almost four thousand deaths the virus spreading in considered widespread in forty in many areas it is beginning to decrease the burden of illness but in some it is still on the upswing there's been no change in the illness pattern still disproportionately a younger person disease many people with underlying conditions are pregnant proportionally affected with severe complications so far no change in the virus that hasn't become more virulent or changed genetically we still think the vaccine is an excellent match with this virus circulating but unfortunately the trajectory that the virus will have is unpredictable we do not know how long this wave will last whether they'll be multiple layers of waves we know that  until usually we don't know how much seasonal flu strains will have many unknowns and that makes it even more important that we strengthen our response without the investments of congress in preparedness and strengthening our ability to we carried out epidemiologic and laboratory surveillance in the u s and abroad to understand what was going on and direct our interventions our aggressive response has been science based we have rapidly deployed life saving any viral medicines and other material from our strategic national stockpile laboratory kits were prepared in record time and disseminated to all of the public health labs here in the u s into one hundred fifty other countries we deployed field teams to support the state and local response and continue to support the state and locals in what is very much an implementation effort at the front line we've issued science based guidelines on prevention and mitigation we expected to increase before vaccine was available so we work very actively with other sectors to make the best use of any medicine in high risk people are in severe illness to work with education on ways to better intervene in schools without as disruptive effect as we saw last spring we focused on businesses and health care workers and so forth communication has been a priority for all of us and we've done outreach with new media and old media and many partners of course the heart of our responses the vaccination effort right it's been unprecedented in with which we've gotten this vaccine but of course like everyone i'm disappointed in the initial production and we've been held captive really to the slow growing virus however today i can announce that there are forty nine point nine million doses of h one n one vaccine that are available for the states to order it's not as much as we wanted to have by now or frankly what we needed to have by now but every dose that's coming out is being rapidly moved to places where it can go into people and be and help protect them at c d c we work to develop recommendations to prioritize the use of care for those at highest risk of disease or most likely to spread  we have a distribution system that gives a pro rata population share of the vaccine trying to have as fair a process as possible the states and local health authorities are the implement s they are deciding where that gets shipped they're working very closely with the provider community the local health departments hospitals with community health centers with other schools for instance where vaccination efforts can go forward rapidly thirty four states so far have initiated school located vaccination efforts to really reach large numbers of children probably not as many have been able to be completed because of the supply but more happening every day and we know that the state of forefront for many and so we've done this without cutting any corners on safety and of strength that our safety monitoring system to address any and then to support a problem we're working hard with partners across government and in particular with the state local and tribal authorities who are directing the program where they are they have been working tirelessly to make this and i'm happy to detail some of the efforts they've been making in the in the comment period when we have the opportunity to look back on this public health challenge will have time to reflect on the remarkable scientific accomplishments that made it possible to rapidly detect and track a previously unseen virus and get a vaccine developed in record time we'll have time to more systematically search for lessons in production and delivery that we can apply in the future pandemic and to rebuild the public health system that we all rely on but today we need to quickly adapt from our recent experience and maintain our focus on the days and months just ahead we will have more vaccine to put in the path of the virus and it is our commitment to continue to work closely with our state and local public health partners to ensure that it is as affectively delivered to those who need it most i look forward to answering your question interagency secondly to stimulate the development of and contract with for vaccines and and third to monitor and ensure that we can backstop states and communities if they get overwhelmed by request our help and finally to stay prepared for any other emerg y not to take our eye off the ball this whole response has been a public private partnership from the get go starting with vaccines as you know we developed a new vaccine with unprecedented speed and this was really made possible by investments in basic and clinical science manufacturing regulatory processes and would not have been possible at all without our partnerships with industry and while modest amounts of vaccine came ahead of schedule as the graphic over here details on the left a combination of poor production late completion of seasonal vaccine problems with new filling life decisions on the home country of one manufacture cost and the availability of vaccine not just for the u s but around the world and while the number of doses that are produced and distributed to ministers continue to grow we remain vigilant to ensure a steady supply of vaccines we talk with manufacturers almost every single day we constantly monitor the progress of every lot produced working to make up ground wherever possible and right now we have full time staff in the facilities of two of the manufacturers in addition secretary sebelius and i have spoken directly with the actually on several occasions seeking to identify opportunities to work together to be sure that there are no kinds of obstacles in the way and while these delays are really frustrating to everyone we do need to remember that the virus is the real enemy here and the way forward as we've been talking about this morning is to improve our country's domestic manufacturing capacity using newer faster and more predictable technology so that the virus of the future just not defeat us in a viral have been another critical aspect of our response and i just want to point out that we've supported the development of new viral issue in the first emergency use authorization for an intravenous and a viral and we have procured over thirty million to thirty thousand doses across three types of anti viral drugs we're also focused on ensuring the health care system and communities throughout the country we made able to care for those who need it c m s can now granted eleven thirty five waivers to decompress hospitals and other facilities when they're getting overburdened letting them use those emergency plans and we stand ready to deploy federal assets when necessary including vaccination teams clinical laboratory staff and temporary medical facilities and our first ever vaccination team is headed to delaware to do just that we've also partner closely with the private sector health care system including health insurers pharmacists big box stores and the public health community to find ways to pay for vaccine administration costs is not a barrier to people who want to be vaccinated let me shift for a minute to lessons learned clearly the support of congress in the fast past two years has been critical in enabling us to respond quickly to this pandemic and yet it is clear that chronic under investment of public health whether at the federal state or local level or in the manufacturing infrastructure has real world consequences and we cannot afford to let this happen again ever what we've seen in record time without cutting any corners in retrospect our original projections were based on the collective experience with seasonal flu and with five n one vaccine manufacturing and we're optimistic in the face of what it's proved to be a daunting challenge provided by mother frustration for everyone involved especially the public as an important part of this transparency and part of our public private partnership we will start releasing this week together with all five manufacturers the number of projected  sure the vaccine could be ordered so the clinics could go on as planned but we are far from done with the science of advanced development related to vaccines and with building manufacturing capacity in the united states we're excited that the first diseases until we all are i thank you for your support for public support for the f d a and your interest in this issue thank you very much thank you dr goodman and thank you to all of you the way we proceed now as we have five  minute period of questions from members going back and forth democrat republican from members who passed on their opening they get seven minutes to get their opening to the five start with myself and i want to start with doctor  the big concern the biggest concern that i hear from my constituents is about the distribution and i know that the c d c has guidelines for distribution of basically leave the distribution up to the states as long as they meet those guidelines and my concern is whether that's a good way to go about it i mean i suppose you know you assume that the states in the locality since they're closer to people would have a better would be the best way to but that's been seriously question the last few months or so and of course being from new jersey the biggest issue has been the wall street companies you know goldman sachs group i literally being about this constantly you know why is it that new york i guess you know gave goldman sachs and wall street firms the opportunity to do this i'm told that employer based distribution is  to meet your guidelines and perhaps it was assumed that you know they would be good they would do well since they have health clinics and you know have a good distribution amongst their employees but i guess the concern would be you know if you leave the distribution to those who do it best in the ones that do it best happen to be you know high powered wall street firms then it there are two concerns one would be does that make sense given that maybe a hospital or school might not do as well a job at distributing but there's a greater need and then the second thing is whether or not you know some of these firms would would only give at the high risk people and as opposed to maybe their c e o s or somebody else so i mean  that's a concern i mean my question really would be why does the c d c leave it up to the states to create the plan for distribution and wouldn't and that it would perhaps be better to have you know some other federal mechanism rather than doing it this way and and what prevent you know what prevents you know that somebody like goldman sachs you know getting when they maybe should be going to a clinic and  a national level level setting we leave it to the states or the large cities like new york city to find the best ways to put back in the path of the priority population to identify the venue new york city actually know that goldman or others are giving it to people other than the high risk some of concerned about that but it's just that have you thought about the fact that you know if you do it that way or if the states do it that way it may be giving it to people that have a better distribution network within their employers but they may not have as great a need or i mean it's sort of like you know when when there's a grant program and the guy that does the best has the best grant application person gets the grant  need for the person who doesn't have an expert to do it you know we have had a major commitment to vulnerable populations into the under served and to make sure that we're not leaving behind those without good access most of the states have carried out these larger distribution is better as opposed to maybe looking at some kind of a federal alternative i don't know if you've looked at that but if you could get back to at some point and then the other thing i wanted to ask dr laura is that when secretary sebelius testified before the committee on september fifteenth i mean basically she left us with the feeling that we were on track in terms of adequate supplies a vaccine i know that turned out not to be the case some of you explained why and i'm sure we'll get more questions from other panels but you did mention underfunding and i don't remember her saying anything about a lack of funding underfunding or chronic underfunding was one of the contributing factors that's the first time i've heard that and i was a little disturbed because i don't remember her mentioning let me try to clarify here i think the chronic underfunding has been in the vaccine infrastructure overall as opposed to the response so it would have been wonderful if we had had more manufacturing capacity in the united states by this point if we'd had the recombinant technology that could surge and really produce large amounts of vaccine but you know while we've invested in that over the past two years we need to continue to make a much more robust investment and so that's the kind of chronic under funding for the vaccine manufacturing capacity i think love to see us in a situation of is that we can sort of apply prevention in that sense to and really get ahead of this for the next pandemic or that well i you know again i don't i don't want to say i don't want to beat you guys up today but i mean you know when it's something like that that congress can make a difference it really is important that if the department or anybody feels that there's a need for more funding to detail that and you know again i would ask you maybe to get back and give us more information about this chronic underfunding in writing because you know a lot of things that come up here we can't do anything about but that's certainly something that we could this rosy picture i think you know that blaming the manufacturers or i don't i don't think anybody is to blame here i don't think that there's a gun and i want to i want to make that really clear it is a very complicated process what we've tried to do is put together a little september fifteenth and i walked away thinking wow that's a pretty strong statement to say we're going to have everybody on schedule on time twenty million doses in october whatever the number was and then we got people waiting in line for hours and  to a different topic then because one of my call had to leave wanted me to ask if we could get for the committee the contract you entered into with the manufacturers what good is that some you can provide and then one of the questions that's come up is attacked biological weapons of mass destruction and it really keys into what we have to have a way to streamline the process and get approvals quickly and that would be the debate on l versus l and how quickly i understand the ability but but if you have a massive possible pandemic we better have a way to subvert the regular order for the needs of the  ago but we have a long way to go and i'll just end by saying i think education is the key and what the positive aspect is is the public is really better stewards of everybody else's public health by better health practices and that will be chairman i mentioned in my opening statement three topics that i hope to hear more on i know that i won't get a chance to exhaust those three topics and but let me let me start with dr laurie on the issue  of domestic production of vaccines that you had been asked a question by mr walden that i think time didn't permit you to finish answering regarding the policies in other countries where the vaccine  manufactured and i wondered if you could basically generalize those policies but also tell us what happened in the case of australia sure i think many countries including the united states and united states we have the defense production act and basically what that tells us is that if we need you know material for the safety and security of this country that we can we can prioritize that and i think many countries  have that kind of situation that they need to prioritize their home country that's why it's so important for us to get to domestic manufacturing capacity in the united states it's actually something that we learned and realized during our pandemic planning early on and in fact even earlier than that when we realized several years ago that we were down just to one license limit affection the united states and i think people for the hard to get to the point that we are today and now we need to get to the point where we have much more domestic manufacturing capacity i think in the case of d s l they're based in australia and they have a similar kind  of arrangement requirement with the australian government remember that the southern hemisphere has its outbreak at a different time and so australia has experience seeing a pretty severe outbreak and decided that it needed vaccine first for its home country now when that happened c s l let us know that right away we immediately were able to downgrade our projected numbers of doses of vaccine and at the same time we worked very closely with the manufacturer so that as soon as they met their requirements for their home country they were able to start making and shipping doses to you know in addition i think is as you heard they've also submitted to digital data recently so that their vaccine can be used down to a lower age in children and that was really recently by some i also in my opening statement talked a little bit about using  this pandemic the seasonal flu as well as the h one n one to learn and to innovate and i'm wondering what your thoughts are in three particular areas one is faster vaccine for another year but when all said and done that ought to get us to the point where we can still be able to make i think one hundred fifty million doses so that's still far short of the capacity that we with the surge capacity would we would need in a public health emergency in addition to require the virus to grow and develop and so we need to move toward common in technologies and other kinds of technologies we have invested  in some of those i think it's i think there's a lot of promise in a number of the new methodology i can't yet predict where they're going to come online but i also want to say that it's great to be able to do those things but once you do th we forget that we have to manufacture to scale with whatever those are and so we have to be thinking now about how those new technologies and manufacturing capacity one another so not everything is done one after another you know i have some concerns in the interest of full disclosure i've been a bit of our doubting thomas as a physician member about our response to this crisis  pandemic as it is now and of course my great concern was creating a pandemic of fear i think we have certainly done that and we also have  thousand and six when we were dealing with avian flu probably in the aggregate have appropriated something like twelve thirteen billion dollars feel free to correct me if i'm wrong on my numbers but a lot of money and of course guantanamo received it if they wanted to go in tunnels got it you don't know if the two hundred international terrorist we hold in u s jails has received it you don't know that because that's handled by a different party what i can tell you is like a military installation and what is your source than i certainly and i would really second comments about really strengthening the public health infrastructure at all levels in addition to talked about some already this morning we do need to get to much more robust manufacturing technology we talked about the fact that there are some promising new developments and we need to continue to invest in pulling those kinds of technologies along so that they can make vaccines faster and more reliable and then at that those new developments have to somehow meet the large scale manufacturing capacity so that to have another emerging infectious disease another kind of pandemic that we would be able to get  ensure this committee that c s l bio therapies is committed to providing the entire amount of both the h one n one bulk antigen and the finished vaccine doses that we have agreed to in our contract with the department of health and human services we take the h one n one pandemic very seriously influenza vaccine annually our seasonal flu vaccine floria was launched in the united states in october two thousand and seven and indicated for ages eighteen or above and as you heard dr goodman state last week floria and r h one n one vaccines received f d a approval for administration to individuals six months through seventeen years of age as well floria and r h one n one vaccine come in multi dose vials and primary prefilled syringes c s l initiated the western world's first human trials with the two thousand and nine h one n one vaccine and published our research findings in the new england journal of medicine demonstrating the efficacy of a single fifteen micrograms these data along with the results of clinical trials in infants inquire whether we might be able to provide an h one n one vaccine for the united states therapies entered into a one year special contract initiated on may twenty eighth two thousand and nine to provide thirty six million doses once of h one n one from the new york medical college the us from this lot were approximately one third to one half of the average h one n one seasonal influenza you as a result of these low yield c s l formerly communicated apart of a delay to the overall timing of the h one  gin delivery on the eighteenth of august received a new vaccine diversity that was introduced into the manufacturing process improvements in excess of eighty percent compared to the previous observed a revised supply schedule vaccine first i would recommend there be a focus on producing a greater assortment of influenza earlier that can be utilized in the creation of future pandemic influenza vaccines for yields resulting from the first available response and reduce required dosing which would make more antigen available for additional vaccinations a supportive environment for development of new events with influenza vaccine could facilitate in this advancement finally more education about the benefit of influen vaccination and the achievement of higher vaccination rates closer to c d c recommendations would help to prevent influenza and support readiness are passionate c s l biled therapy to help save and improve lives we wish to do our part in protecting the united states population from h one n one and seasonal influenza we'll continue to work with the government collaboratively thank you for the opportunity to speak before the committee and i welcome the opportunity answer any questions thank you dr who like t greeting leading global vaccine manufacturer headquartered in cambridge massachusetts along with our predecessor companies we have been a leader in the development and supply of influenza vaccines to the united states for over twenty five years today i would like to highlight to the committee novartis vaccines commitment to us influenza pandemic preparedness and our dedication to help prevent every possible illness and death from influenza we commend h h s for global leadership in pandemic preparedness over the past five years we have had a broad and successful partnership with h h s including active collaboration on culture vaccines adjutants stockpile and new production facilities devoted to vaccines is committed approximately one billion dollars in influenza vaccine development and production since two thousand and six importantly with h h s support we are constructing the first lou cell culture manufacturing facility in the united states located in holly springs north carolina and with its ribbon cutting ribbon cutting later this month this facility will help ensure the rapid for the american people in the future for this pandemic we have continued our commitment to u s pandemic response and public health first in may voluntarily dedicated the entire vaccine output from our men manufacturing facility in liverpool england second our entire organization has worked around the clock to support us back to in production we've made large new investments out of three hundred additional stop accelerated new production lines and have been operating our production facility with a high level of quality and efficiency third we rapidly started in enrolled a broad range of clinical trials and more than nine thousand children and adults in less than three months our data showed in early september a single dose as opposed to two is adequate for adolescents and adults and we recently showed that i have to  sufficient fourth we have prepared for h h s to use our i am a fifty nine adjutant that is currently license and being used exclusively in our product outside the u s for h one n one we have demonstrated in recent u s pivotal clinical trials that are adamant could significantly increase u s a two thousand and one vaccine supply we successfully supplied twenty seven million doses of seasonal flu vaccine to the u s by early october now most importantly in partnership with the u s government we have overcome tremendous challenges to produce a safe and effective pandemic vaccine in less than three months the challenges of include a low yield multiple production uncertainties and compressed timeline despite these challenges as of today novartis vaccines are shipped over eighteen million on the edge of n a doses to the u s government and we are fully on track with our production a tremendous joy accomplishment we also believe based on the experience this year there are important opportunities to improve pandemic preparedness in the future these opportunities include the need to move manufacturing into the twenty first century for influenza vaccines using new technologies such as ourselves culture based technology now being used licensed for seasonal pandemic use in europe there's a need to accelerate regulatory pathways for novel influenza a we need to develop new testing methodology to speed up vaccine formulation and quality release which can often slow down vaccine availability we need to maintain the strategic national stockpile for rapid deployment in the case of a severe pandemic and finally as  other members we must support seasonal influenza vaccination demand to ensure that suppliers are not forced out of the market as it happened in the past novartis vaccines continue to do everything possible to maximize the rapid supply of a safe and effective vaccine in close collaboration with h h s we believe that when taken into full contact the productive public private partnership to produce test and deliver a safe and effective h one n one vaccine to the us has been a remarkable success we are fully committed today we have finished the manufacturing of all forty two million doses of all of these is now on u s soil we are now in the process of failing the fact in the specialized single dose nasal spray  it is critical that the u s government continue to encourage high level of sex and ice and as well in fast in public education campaigns that increase awareness of the benefits and options seen him in the influenza vaccination additionally it's key and we look forward to building up our successful relationship and collaboration with the u s government i will be please answer any questions thank you dr ross back to your testimony plays thank you for the opportunity to testify before the subcommittees regarding when and when influenza that pandemic production development and delivery my name is in the vice president immunization policy and government relations for the past year and i'm currently responsible for coordinating the company's worldwide u s pandemic response team set of the past year is the largest manufacturer of influenza vaccine globally in the united states producing about forty five percent of the u s annual influenza vaccine supply we are the only major factor of an activated flu vaccine on u s soil and all of our seasonal h one n one vaccines for the u s market are produced in swiftwater pennsylvania this site which includes a state of the art influenza vaccine manufacturing facilities and one of those was just this year as you heard from goodman they are operating twenty four hours a day seven days a week with more than two thousand dedicated people involved in some way in getting the vaccine out the door people have made great personal sacrifices to ensure that we produce the largest number of h one n one vaccine doses  the shortest amount of time while ensuring vaccine safety and regulatory compliance i would like to start my remarks today by focusing on what a remarkable achievement the u s response to this pandemic really is thanks to the close collaboration of industry w initiated and by early october there was an f d a approved vaccine being administered it truly is a success story nevertheless we certainly understand the committee's interest in this process as there are always opportunities to  however the initial use rate one and one were exceptionally low utilizing our expertise we have been able to optimize the productivity of our current when we yield should not be a significant factor going forward since april thirtieth we have participated in  weekly phone calls with h h s agencies including barda c d c f d a and during which we provided ongoing updates we've always been transparent about our progress we now project that will not only catch up completely but we as a very sophisticated process that is proven adaptable to emerge situations like the current pandemic in fact this year provides us with an opportunity to directly compare the vale ability of flu vaccines produced with a base technology and those produced in europe using cell culture end of the message of the message produced clinical lots within similar time frames and large scale production was initiated nearly the same time contrary to popular perception cell culture is not a new vaccine production process it's been around for about twenty five years and is not a substantial time when it comes to producing influenza vaccine it does not produce a safer or more effective vaccine and is not necessarily increase which is a critical variable this year the production of an influenza vaccine involves many steps many of which are the same to the individuals that need it and there's differences between how the managed that because of the different structures within public health and the perceptions have led to impressions that are not pulling down their full allotment  those sites and give another false impression that would be available and i think that would compound the current challenges that we are having instead of doing that we in the state of texas and work with one and provided them a list of the providers alone ranking member walden and mr green thank you for this opportunity today about our preparation in response to the two thousand nine hundred one n one pandemic i'm here on behalf of trust for america's health a nonprofit nonpartisan advocacy organization dedicated to saving lives by making disease prevention a national priority well i understand that today's hearing is a result of considerable frustration with the current h one n one vaccination program i want to emphasize for critical points first the public health system at all levels of government has moved with remarkable speed in approving an h one n one vaccine and getting vaccines to as many americans as apply as permitted we've moved as fast as or faster than any other country in the world second the vaccine is well matched t circulating virus that has been proven to be safe and effective in clinical trials and offers the best possible protection against the disease third whatever our concerns with production capacity are today admiral government not made the multibillion dollar investment in enhanced vaccine production capacity since two thousand and five we would be in far worse shape the limits on supply are we are experiencing are the limits imposed by the science and technology the decision to use a central purchasing and distribution approach is assured that as supply has become available it has been equitably distributed across the nation and finally the federal government has been remarkably transparent with the american people with about this pandemic since it began last spring public health officials have leveled with the american people making appropriate adjustments and recommendations as our understanding of the nature of the pandemic has evolved and as supply issues have arisen the response to this pandemic has mobilized all levels of government while the federal government has assumed responsibility for distributing vaccines to state and local health departments each locality is then responsible for developing its own policies and systems for administration of the vaccine this is posed a number of challenges particularly in the context of vaccine shortages first local health officials received constantly shifting information about how much vaccine would be available and when this is clearly an issue that is not only created confusion among the american people it is also made the job of local health officials far more difficult second the largest mass vaccination campaign in u s history is taking place when state and local departments are experiencing devastating losses because of the recession while the federal government has rapidly pumped almost one point five billion dollars of state local health departments for pandemic response this does not address the underlying decline in the core capacity of health departments and third public confusion may well have been exacerbated by the fact that each state in locality has determined how to distribute its supply once received from the federal government although each health department based their plans on a larger supply of vaccine h h s may want to revisit this issue and consider some standardization in future emergencies is our hope for this hearing will contribute to the public's understanding of the complexities of the current pandemic influenza vaccine campaign among the key an issue maintains are critical to the success of the response to this and future at epidemic our first and education campaign is needed to assure the american people about the safety and effectiveness of influenza vaccines and all vaccines in general it is important to remind americans that even with the delays in vaccine availability they should get vaccinated as soon as they can we have not seen the end of this pandemic f d a should move forward in the setting new technologies that are already in use in other countries including the use of a vaccines however to move forward on and on an expedited basis without the standardized review would probably have undermined an already fragile confidence in the vaccine system congress and the administration should also come to  consensus on what is an appropriate level of investment in new technology this pandemic has demonstrated the nation such as a long way to go not just in vaccine technology but with regard to diagnostics and anti viral treatments as well as personal protection of quitman the biological advance research and development agency has been chronically underfunded since its inception its its support is critical to moving promising developmental technologies into mass production professional estimates suggest that barton needs an annual appropriation of one point seven billion dollars rather than the current two hundred seventy five million dollars to achieve its mission we need to provide ongoing support to state and local health departments and building capacity to respond public health emergencies just as we don't fund fire departments at the moment the fire breaks out we must move away from emergency funding mechanisms to respond to public health emergencies this is one reason he supports the mandatory funding for core public health functions that is part of the house health reform bill finally congress and the administration should assure replenishment of the strategic national stockpile for supplies that have been distributed to states such as and ninety five respirators surgical masks and anti virals we do not know what demand a future wave of this pandemic strain will choir of the s n s nor can we forget the potential for other pandemic strain such as the h five n one bird flu that is of primary concern until last spring this pandemic has shown both our government at its best and highlighted many of the ongoing weaknesses in our public health system as we continue to ramp up our response we must also take steps necessary to assure that when the next public health crisis occurs a stronger system is in place and capable of responding quickly effectively and then thank you and i look forward to your question thank you and thank you all for your testimony licensed it in europe in one thousand nine hundred seven we have a pretty broad range of clinical studies now up to two hundred thousand subjects and non controlled trials and about forty thousand subjects in controlled clinical studies and to date we have not seen any significant not we're going to use it because the united states have they ever discussed that with you we had a discussion with them in early may as to how to how to proceed and a decision at that point was only use licensed platforms us license you can actually make them respond to the vaccine you can increase the number of doses another valuable thing on the agilent which was not as relevant in this case is if the virus changes on the spring of the virus changes there might be the need to revaccinated everyone in the u s whereas with the  cover a certain amount of variation in the virus we've seen in our clinical studies now we haven't looked at that yet in this case but it would at least provide you the ability dr levy is it fair to ask you is it fair to say that this is something we ought to look at as a country i mean the f d a has a license that i know you mentioned in your testimony about making sure drugs approved and that's my concern i'm sure i was concerned on this panel are we missing something here is something we should look at closer would definitely something we should look at closely and i i believe the f d a is doing this in a good faith manner i think you know when you think about who we are targeting for this vaccine the bulk of the data for using the advent of vaccine occurs with the elderly that's not who is targeted in this vaccine and so we're just beginning to get the kind of data that would be associated with kids and i but i think the larger question is we have so much vaccine has it's in this country so much in accurate knowledge about whether vaccines are safe and particularly whether the flu vaccine is safe to add on through an emergency use application application a new element parents whether or not they want their child to be back with an h one n one vaccine that's needed as opposed to not it is sometimes hard to understand why there is so much hesitancy around vaccines in general and ru particular vaccine i think we had a real public health question as to whether people would accept a vaccine that had a new product in it now if things had been worse than this had been a much more severe pandemic we may have needed to go that way anyway because whatever risk around has and the might have been overcome by fear of the virus itself but i don't think that's where we are i do believe that we need to move expeditiously in preparation for any future p sorry i didn't say are actually additives that we put into vaccines that actually boost the immune response so in this case what we would do is we'd make the vaccine as we normally would make it out in the event and then see how the vaccine nothing out of the band looked at in our clinical trials i also just wanted to correct we have now twenty five thousand subjects that are non elderly so it's not that we don't have data now that we have quite a robust data set in the in the non elderly population we only see so we filed for the which would then allow us to take the steps ok for the approval our intention is our intention has been to use our european data to try to to try to move forward the question always has been how much data needs to be repeated in the u s on in europe controlled randomized study under f d a oversight that demonstrate the safety and benefit of the vaccine we have a lot of data a lot of it's most of it's been generated not under at the oversight with the european oversight and the question for us as a company is how much of this can we realistically be expected to repeat and of course with flu vaccines being as profitable or not as profitable as they are or as they are which is a they're not  lee going back then well let me let me run this on i mean if this were the feared avian flu that we had hearings on the potential of four out every ten dying because of it i guess we would declare some sort of emergency and take whatever risk there is but if you're if you're using this method fifty nine europe you're not seeing any problems  seriously with h five n one it's very difficult to get the an advantage back seems to work so hence the am at fifty nine becomes agence in general become much more important in this case because they had an advantage vaccine that worked i think they were more reluctant to move and the f d a are on and i realize the regulator and approve are and you have to you know be really nice here but i don't mean to put you on the spot just just for my sake the public say what kind of timeline the way the way we look at this is we have an h one n one advantage we have a seasonal advantage we have an h five n one admin and our goal is to get one or all ideally all of the licensed as soon as possible and we would be willing of course the pile as soon as we can find a pathway with f d a that makes sense but i think we would be unwilling to repeat large clinical studies and incur all the costs if that's what ultimately going to be required unless unless the government helped us are we the only country that doesn't allow the  it's being used in clinical trials with new vaccines are being developed by other companies that we partner with and as you've used it in other countries if i understood you correctly on the studies four x five and one in the other in australia and did you find any were also able to produce an a fifty nine in the holly springs facility and we expect b m a fifty nine sweet and always runs north carolina to be operational in december all right my time is expired i know we have other members here want to ask questions like mr chairman thank you chairman blow thank you i was going to use my time by dr lake here because you're the state guy and i don't know if you were here when i asked the first panel but all my questions were about distribution and also about funding because dr lori brought it up basically you know that c d c has left it up to the states to decide how to distribute the vaccine so i wanted to know how state decides which entities will distribute vaccine you know how many doses they receive and essentially do you agree with this decision should be left to the states or should they be dictated by the federal government maybe a little more strictly i mean i know they have guidelines but you know i don't know if you were here before but i've been getting you know all these criticisms in new jersey about the wall street firms getting you know the vaccine because they can distribute it better or you know that some other places so you know i'm we're hearing in my own state in new jersey and in new york about you know major disparities one school district versus another gets it one gets it the other up funding challenges i was a little critical because i don't remember the secretary mentioning that when she was here and if you need money this is the place to come for the most part these days talk to me a little bit about that i mean to what extent the lack of funding or intermittent nature of it has been a problem sure i think there's a couple of federal funds that have been made available you know after nine eleven a lot of funds were made available and then it you obviously feel that it makes sense for the states to have a lot of discretion here in other words you wouldn't suggest that the federal guidelines be strengthened or made more detailed at this point you believe the state the leeway to pretty much do what they want pursuant to the existing guidelines the clarification that the folks that are being vaccinated right now by the guidelines in terms of the distribution distribution system i think where we are right now  hundred versus one through seven doses can you explain that to us and why that i mean if we're talking about needing a lot of doses from the layman's point of view it sounds like a  and to actually consider this technology as part of pandemic preparedness i can tell you we we have manufactured over one hundred million bulbs and we could easily have gone up to two hundred million dollars  nasal spray issue is not for pregnant women but but there's a lot of other i mean the other two groups there would be no prohibition for them is that  is thank you dr leahy and the title of the hearing is an update on vaccine production and distribution and when i initially read that i always think distribution is can drug get from point a to point b i think what a better title for this would have been in the decision making matrix of who gets it not for me there is no congress to be able to hire individuals to allocate that but all those things have to come together so that's one part of our system we're able to do that now in texas because as we've tied up the number of groups we've been reaching the  planning kids would be not would not that it would be more like seasonal flu and the elderly would be most vulnerable as it turned out young kids were the most vulnerable and so having we had a strengthened school clinic an really something along the lines of a universal flu vaccine which you could stockpile it covers all different variants of flu strains over over the course of seasons or that's a long ways away in terms of saving time whether it's cells or eggs or again dealing with mother nature you have to adapt the virus to the system that you're utilizing and perhaps with cells maybe you save a two or three weeks but in terms of of capacity overall production capacity i don't think that it's really a game changer to get virus out there about the about the same time type vaccine so there's plenty of capacity right here on u s soil with a new facility one new facility our existing facility we really need to look at is why are we immunize ing as many people as we should be immunizing basis when thirty six thousand people die every year and two hundred thousand people are hospitalized we have recommendations from the that two hundred seventy five million people should be immunized on an annual basis we're likely to mean a one hundred million people if you want to sustain influenza immunization production development new technologies we really to make sure we get more people immunize for the benefit of public health and for standing army of factoring capabilities so the capacities here whether production the united states or and i know we have a on and on edge of an addicting microgram dose was not sufficient in fact many manufacturers took ninety micrograms which is six times as much which means the supply collapses and so as the only manufacturer that actually produces cell culture based vaccines we actually expectations a little different view is that it's on the order of sixty weeks but it's not massive i mean it's going to be on that range of again you get with cell culture but as as dr make you lazy also mentioned with the reverse genetics and using some new technologies cell culture allows you to actually meet the needs of many of the changing viruses that are out there in the worst case scenario for the american public is you rely on a single technology that technology doesn't work when it's a different influenza strain and then suddenly you have a real when we signed the contract within three weeks we could see that the virus was not growing well so we started beginning of june and we could see that the range that we had were not developing in fact they were to a third of what we had expected and again we  so actually just the same for us in terms of realizing that we first started out on a very conservative estimate in terms of the virus and it actually was about sixty percent of what we thought it was going to be even on a conservative number and we had weekly phone calls