well good morning everybody i wish we were not here today under these circumstances but we have a problem that has frankly frustrated me and i'm sure a lot of other people for at least the last five years let me welcome subcommittee members and our panelists to this briefing on the h one n one pandemic frankly this committee  my view has had both a positive and negative effect on the issue of preparing the nation against the threat of pandemic early on in two thousand and five president bush requested seven point one billion dollars to boost vaccine production capacity to stockpile and type virals and to state and local emergency preparedness congress responded by appropriating one point one billion dollars less than the president requested since two thousand and seven it has been sort of the flip side of that this committee has been consistently pushing to do more than both the executive branch and the senate appeared to be comfortable doing in april of two thousand and seven the committee proposed nearly one billion in supplemental funding for the for pandemic activit but that investment never saw the light of day because it was vetoed in november of two thousand and seven the committee try to get on with nine hundred fifty three million in the regular fiscal year two thousand  two thousand and nine with four hundred twenty million dollars in the house version of the recovery act for pandemic preparedness but even those limited resources met with resistance from the senate  of the novel h one n one flu virus in april of zero nine we've been racing against the clock to get ahead of the virus in the spring of zero nine the obama administration requested three point five billion in emergency supplemental funding and requested some flexible authorities in response the committee in june of zero nine provided an additional seven point seven billion to address this extraordinary challenge the committee pushed hard for those investments because we wanted the country to be ready when the second wave of the pandemic nation is made significant strides since the initial outbreak of h one n one flu in no small measure due to the very people sitting before us here today have been working around the clock since april yet despite some successes so far the virus seems to be winning according to c d c some forty eight states reporting widespread influenza activity nearly six million people have been infected more than twenty one thousand people have been hospitalized and more than eight hundred people have died including at least  hundred fourteen children in two thousand and four this committee on both sides of the aisle began asking questions about the insufficient supplies of vaccines and fluctuating demands for seasonal flu virus and the steps of the government could take to boost production levels including guaranteeing some government purchases so that manufacturers boost production levels and have an incentive to invest in new technologies i would urge members of the subcommittee to go back and take a look at our april two thousand and little progress we have made over that time in dealing with this production issue and five years later it's clear that we're still using nine hundred fifty zero technology as and we are years away from state of the art technologies that have been in other countries for at least a decade u s vaccine production capacity is still completely inadequate h one n one vaccine supplies are lagging far beyond behind the need by the end of the year we still may not have enough vaccine to it to expand beyond covering high risk groups to the general population moreover the country faces other public health challenges for example of the distribution pipeline to states local communities and private providers for seasonal n h one vaccines and i virals and ninety five respirators played with rusty plumbing many providers have no idea how many of those critical supplies they will receive and when they will receive the state and local health departments are further hampered in confronting this public health problem by state budget shortfalls that have resulted in the loss of approximately fifteen thousand public health jobs since two thousand and eight i find that number most disturbing and astounding with this briefing we hope that we can have a substantive and somewhat informal conversation with h h s state and local public health officials so that we can ascertain exactly what the facts are regarding our current level of emergency preparedness at the federal state and local levels so that we can understand how quickly a response efforts can get ahead of the spreading virus instead of being behind the curve and  y the lessons learned to date so that we can be better prepared in the in the future when i when i initially was talking to the staff about this problem i had intended to simply have a briefing for me as chairman of the committee to try to figure out what problems were but the more i thought about it the more i  to simply have the briefing for the entire subcommittee and given the fact that there's so much public concern so much public confusion about what the facts are we thought that it would also be useful to invite whatever or  at least to provide access to whatever members of the press wanted to participate in the hopes that they perhaps could do a better job of conveying information to people than we have been able to witnesses or our guests i should say after they after they made their comments i'm going to ask the staff to proceed to ask what they consider to be the most  need to be gotten out of the way and after that we'll turn to any member who wants to ask questions for five minutes until until we are interrupted by so many roll calls that we  we wind up leaving in chaos as is often the case with when we're trying to get something done in competition with what's happening on the floor so let me simply tendency in washington d c to try to assess some sort of blame on why we are where we are today but you know each administration has about four thousand people that they get to appoint and there's about three and a half million people who work for the federal government so it's the reason we're in we are where we are and we could point a lot of fingers a lot of directions i think what we ought to we're moving into sort of a briefing format rather than a hearing as wanted to say that there are problems with the number of manufacture we have in america we have fewer now than we did a decade ago i think some of that is based on what barriers the federal government has placed in front of creating businesses and keeping jobs here in america success you bring elations a tax structure that punishes success it's a litigator system it's our failure to be energy independent and when you add all these things together it becomes less expensive to manufacture products that are necessary for the health and well being of this country forces  overseas and then we get overseas for example new york times has reported that manufacturing the liquid flu anti viral similar to tamiflu can be made but we have not approval from the f d a so when we move jobs offshore capacity offshore for building very important products like tamiflu because of our own barriers created by the special government and its elected officials and we wonder how we get in these kind of situations to our detainees in guantanamo bay and yet we don't have enough for our seniors here in america so i think we have to move forward and figure out how we're going to recover from that and how we're going to move because we do have millions of dollars less than we thought we would have i have other questions i change in the future in order to strengthen our capacity to deal with this in the future and with that let me simply ask each of you to take roughly five minutes and simply give us whatever comments you'd like to give us before we move to a staff officer in alabama leads the alabama department of public health he will be introduced by congressman boehner and finally mr rob fulton who is the director of st paul ramsey county minnesota department of public health enemy and it's a difficult one to deal with it's difficult to predict changes rapidly it infects widely and has the potential to cause enormous illness and death are harm and carry him to address this enemy is as you said mr chairman out of date and requires updating i'm pleased to have been asked to work under the leadership of secretary sebelius to ensure that the administration implements a comprehensive plan to address h one n one throughout the season i bring to this experience of having been health commissioner in new york city during the spring and having experienced firsthand the enormous challenge in terms of the number of cases the media attention the challenges for the health care system and hospitals and the onus and the h one n one can cause first to briefly update you on where we stand with the situation as you men chairman the virus continues to spread widely it is now widespread in forty eight states there have been as of now many many millions of cases of h one n one influenza in this country we had well over twenty thousand hospitalizations and more than a thousand deaths including as you mentioned one hundred fourteen at least among children those deaths in terms of pediatric adult destined hospitalizations are based on numeration a little counter intuitively sometimes the most accurate information is actually from estimations based on the best available estimates which will be significantly higher than the enumerations particularly for hospitalization so far there's been no change in the pattern of illness h one n one influenza is not more severe than seasonal flu but it affects a different pattern of people ninety percent of deaths from seasonal influenza are among people over the age of sixty five ninety percent of the deaths in h one n one are people under the age of sixty five this is a younger people's disease in addition disproportionately affects people who have underlying conditions more than two thirds of those who have been seriously ill or who have died have had one or more underlying conditions whether it's asthma in close to a third of the hospitalized cases or diabetes lung disease heart disease and i would comment that the increase in obesity and diabetes is not helping us here and our need to address that more effectively is very important as there has been no change in the pattern of illness there's been no change in the genetic pattern of h one n one at c d c we collect from around the country and around the world samples which are our undergo rigorous genetic testing so we actually sequence to see if there are changes and monitor the speed with which the virus is changing because we know it will change all influenza viruses evolve and mutate and we have at this point not seen significant changes and that's important because it means that the vaccine which is being produced is an excellent match to this virus and that the level of virulence or how deadly this strain is has not increased it is not becoming more deadly only time will tell what the future holds how long the current wave will continue how many months how many places how high it will go and whether when it recedes we will have another wave of h one n one influenza or another strain of influenza later this flu season flu season lasts until may c d c is rolled much of which has been made possible with the additional support from congress over the past several years has been to identify and characterize the virus to develop and a vaccine strain to rigorously monitor the spread of the disease in the u s and globally and then to coordinate response through communication simple things staying home covering cough washing hands and detailed guidelines for key sectors businesses health care settings schools trying to ensure that to the greatest extent possible while protecting the public health we support people continuing to go about their business help kids continue learning people continue working and ensure that workplaces are as safe as possible with treatment we have to emphasize that there is effective treatment unfortunately many people who should be getting treated aren't only about half of people with diabetes or asthma who had influenza like symptoms went to a provider at all so we need to continue to get the message out that if you're severely ill or if you have an underlying condition such as asthma or diabetes it's important if you have flu to see your provider promptly not everyone people who have a routine flu don't need to be tested don't need to be treated but for those who have an underlying condition or are severely ill it's important  i think we have challenges in our health care system in terms of its coordination its information systems and its focus on prevention the vaccination campaign is an unprecedented effort we have substantial amounts becoming available but not nearly as much as we thought would be available or hoped would be available with twenty twenty hindsight it's clear that we should have been more skeptical about the projections that were being made and we anticipated that having five different manufacturers would provide more insurance than it has it's important to ensure that the vaccine that we do have gets to people who need it as rapidly as possible we've taken no shortcuts in terms of safety and we're rigorously monitoring for any potential problems with a vaccine we said in september that there would be bumps in undertaking this effort and indeed that is the case but we're working very hard with our partners throughout the u s government and most importantly relying on state local tribal health departments health care institutions and the public to address this as a shared responsibility that everyone can do something to address we're faced with the challenges that you mentioned with the state and local infrastructure which has significant problems with rapid email logic and laboratory capacity at the state and local levels with workforce challenges and with the tools that we have we're committed to doing everything we can to respond as effectively as we can and also to communicating rapidly openly with the congress and the public continued support to the investments you outlined and despite the frustrations in rebuilding the vaccine infrastructure in this country several years ago and as a result when we decided to pursue vaccine in the spring we actually had preexisting contracts in place with manufacturers already licensed here enabling us to get out of the blocks quickly with contracts to manufacture my office as you alluded to has really a four fold roll related to this pandemic first just to coordinate the h h s response and to work with the inner agency second is to stimulate the development of contracts for the vaccines and viral third is to ensure that we can  backstop states and communities if their health care systems get overwhelmed and request our health and forth importantly to stay prepared for any other emergency you'll recall that we responded to the tsunami in american samoa just a couple weeks back one n one effort has been a public private partnership i think from the get go in terms of vaccine i think as you've heard and you alluded to we've developed a new vaccine with really unprecedented speed and this was made possible by a whole series of investments and i want to say in basic and clinical science in manufacturing capacity and in regulatory processes and obviously vaccine would not have been possible without our important partnerships with industry but while modest amounts of vaccine came manufacturing partners to look at what's going on and talk about how we can work together and we've just completed another round of the site visits in the past week and we monitor the progress of every single lot of vaccine working we can make a round wherever possible last week secretary sebelius and i spoke directly with the c e o s of each of the manufacturing companies seeking to identify opportunities to work together to speed the delivery of vaccines and while these delays are frustrating to everyone they reinforce as i think you already pointed out the need to address our country's domestic manufacturing to test using newer faster and more dependable technologies and we need to do this  proactive step enabling c m s to issue eleven thirty five waivers to decompress hospitals and other facilities if they're getting overwhelmed and we stand ready to deploy federal assets when necessary including clinical staff vaccination teams laborator support temporary medical facilities we partner closely with private sector and health care system including health insurers pharmacists big box stores public health authorities to find a way to pay for vaccine  ministrations not a barrier let me just turn for a minute to some of the lessons learned the support of congress in the last two years has been critical enabling us to respond to this endemic and yet it's clear that chronic under investment of public health whether at the federal state or local level has real world consequences and we can't afford to let this happen again while we've made that scene in record time as dr frieden said without cutting any corners in retrospect our original projections were based on the collective experience with seasonal flu and h one n one vaccine and we were optimistic in the face of what proved to be a bigger challenge by mother nature however we're also far from done with the science and advance development related to vaccines and building robust manufacturing capacity in the u s in other words under investment in advanced development and infrastructure is also chronic my fear is that when this is all over some will decide we don't need to worry about a pandemic for the next thirty years nothing could be more dangerous and much of what we need to do is relevant for any new threat we're going to need to confront not even just the next pandemic so despite the challenges i believe that much of what we learned through this pandemic and the investment that we've made to address that will serv comprehensive approach mounted by the department health and human services and other government agencies in addressing the very daunting problem of this extraordinary pandemic as i've testified before this committee so many times in the past that the mandate of the and i h is to do basic and clinical research in a variety of diseases for the purposes of today's discussion infectious diseases in general and specifically influenza as shown on this  placard on the left hand side on your right we've done and continue to do fundamental basic research and clinical research to address countermeasures both sever putin diagnostics and vaccines today will focus on vaccines i hope during the period of questioning we can get into the considerable investment that was really made possible by the generosity of this committee and giving us funds to do fundamental research to bring the technology or as we call it the vaccine platforms into the twenty first century to get beyond having to grow the virus but to actually do it with twenty first century technology but having said that let me just focus for the next couple of minutes on the problem at hand and the activities that have occurred the process of getting a vaccine for this h one n one pandemic started as you've heard from dr frieden the dr lawry in april that's very interesting because we usually start this process in january when we make a prediction what the flu would be for the next season and we begin with a educated guess that is almost always correct about  matching the virus with the vaccine in this case it was april but this was done relatively quickly but without cutting corners the c d c isolated the virus in april within a period of a couple of weeks we at the end i  had seed viruses that were used to grow enough to give to our grantees to start looking at various components of this virus visa vi its virulence is transmissibility etc more importantly we partnered with the pharmaceutical companies that we had pre arrangements with to get pilot lots to be given to our clinical trial units to ask some fundamental questions that were important in informing us about how to use this vaccine as shown on this next placard this is a map of the united states with the eight vaccine and treatment evaluation units that are time honored for decades which the n i m h continually uses to test drugs as well as vaccines for infectious diseases that reemerge and newly emerging ones they are extensively experience and what they've done over the last several months i think has been very important to informing us about the policy of how to use this vaccine so certain fundamental questions arise so let me put it into perspective for you all remember because i testified before this committee when the h five n one bird flu was upon us and continues to smolder we made a vaccine that was f d a approved that was the good news the sobering news is that it required an outlandish dose of vaccine to induce an immune response that you would predict would be protective in even fifty percent of the people that was not good news so our concern right off was is this vaccine going to be in a genic is it going to do some immune response that you would predict to be protective so we asked a number of questions first in a healthy adults elderly and children does a dose that is comparable to the dose of seasonal flu induce a robust immune response does it require twice the dose does it require two doses and we were very pleased percentage of these healthy individuals in fact a single dose was required we also had to look at children this is very important because as you know the standard seasonal flu generally requires a single dose for older children between ten and seventeen and two doses of children from nine down nine years down to six months i had announced just a couple of days ago that our vaccine trials in children showed that what the and the c d c and our advisory committees have been advising for years in years with seasonal flu holds true also for this vaccine a single dose for the older children and two doses for the children who are younger importantly pregnant women who you heard from dr frieden are particularly vulnerable to not only infection but to the complications of the infections again just two days ago i announce that in pregnant women a single dose of fifty micrograms induced a very robust response that you would predict would be protective in those individuals this is very good news for the pregnant women who have already been vaccinated and good news and encouragement to the pregnant women who want to be vaccinated and are trying to get vaccinated in addition we have ongoing trials on adjutants and hiv infected pregnant women and children and in as manics so with regard to the clinical trials we now know and hope and as you've heard from from from both doctors laurie and dr frieden we're concerned and frustrated by the gap between the demand and the supply but as people get vaccine available to them we know how to use it i want to close just with of one statement about the question i get asked and we all get asked so many times is that the risk benefit we have a very interesting oh miss paradoxical situation where you have a very high percentage of people don't want to get the vaccine and another high percentage of people want to get it and it's not particularly available where they are because of this gap between supply and demand so when people say is this vaccine absolutely safe there's nothing in the world that's one hundred percent safe you open up your door to go out to work in the morning and get on the beltway that's not absolutely safe so rather than saying something is absolutely safe you say what is the risk benefit and when you talk about risk of the vaccine we have decades of experience of making vaccines very similar same company same materials sa process antiquated as it may be it's time honored but it's fragile the risk historically is very small we are in the middle of a pandemic and we see all those the risk of serious disease is low when it happens particularly to young children people with underlying conditions and pregnant women it could be catastrophic if you just look at this the risk of the getting infected and getting seriously ill particularly among certain populations is far greater than the risk of the vaccine and it's for that reason that although we can't say it's one hundred percent safe we recommend that those people get the vaccine when it becomes available thank you thank you very much  health officer since one thousand nine hundred two during that time and before he has been recognized repeatedly for his public health expertise and for his efforts on behalf of alabama's children as well as our four and a half million other  citizens and is one of the leading voices on public health and i know today he represents my home state but he also speaks for his colleagues with the other forty nine states like many other members of this committee mr chairman i represent a district that includes large rural areas but unlike some members of the committee also represent a city with a large international board and more than fifty miles of coastline this represents just some of the unique challenges that come to public health officials like dr williamson he has met those challenges head on and with great success and bravely i'd just like to give a tip of the hat to dr williamson alabama has been a leader in several areas of public health especially in the area of all kids our state version of s chip it's been one of most successful programs in the nation in enrollment as well as in serving eligible children and dr williamson deserve tremendous credit for that so mr chairman thank you for letting me bring to this committee someone who can talk up specifically about how my state our state has helped in spreading in coping with the spread of h one n one and with that we welcome dr williams  thank you mr bonner for those very can remarks chairman o b rights and member to york and members of the subcommittee thank you for the opportunity to scribe one state's experience with h one n one two thousand and nine many issues with which alabama has dealt or generalizable to state public health agencies across the nation in my comments i'll focus on a few critical components of that response surveillance medical care capacity in vaccine administration scoobie gan alabama in mid august within days of the onset of we began to observe the spread of influenza like illness and h one n one disease in our school system in late august fifty three percent of alabama schools had an absenteeism rate of greater than five percent fortunately by late october that percent had declined forty five percent the percentage of influenza like illness and physician offices began to rise shortly after the onset of and has remained elevated peaking at twelve point three percent a position office visits currently twelve of emergency room visits are attributable to since early september influenza like illness is accounted for between three and three point eight percent of all hospitalization geographically alabama has reported widespread influenza activity for nine or ten consecutive weeks at this point surveillance suggest that while alabama has an ongoing influenza outbreak the magnitude of that outbreak may have peaked since early september we've also been monitoring medical care capacity and we've monitored certain specific indicators at no time has any bad of a lability been less than twenty percent both pediatric medical and pediatric i twenty and twenty five percent during the early phases of the outbreak the department received reports of pharmacists unable to obtain also time of their hours and am of the year in a local geographic areas in addition we receive reports of patients who were indigent or who without insurance which paid for any of our medication and in an effort to address those issues department is provided almost one hundred thousand courses of any viral medication through eight hundred thirty two providers the antiviral stockpiles in alabama currently appears to be adequate based on our current ongoing burden of disease however as has been observed nationally there is a strain on the formulary in pediatric preparations the department formulated a vaccine strategy based for alabama based on projections of vaccine supply provided to us by the centers for disease control and prevention the estimates provided to the department in late september suggested alabama would be able to order approximately eight hundred thousand doses of vaccine b week ending october thirtieth two thousand and nine however new projections of october twenty third two thousand and nine showed that the amount of vaccine available to alabama would be reduced to some four hundred thousand doses  able to alabama prior to the first week of november given this dramatic delay in the release of vaccine the department was forced to reformulate its vaccine strategy instead of focusing vaccination efforts on the broader categories the state has chosen to restrict its initial vaccination efforts to the sub priority groups identified by the i c i p likewise we are now restricting vaccine distribution in the private sector to providers most likely to serve the targets population including o efforts originally planned to began in late october or early november have now been delayed until late november or early december current projections show that sixty two percent of the vaccine coming to alabama will not be available after december the first based upon the current distribution schedule and assuming ongoing demand by the target population it is likely that expanding the vaccine offering to all alabamians who wish to reduce their risk of influenza may not be possible until late december or january and looking at some things we've learned it is critical that estimates of vaccine delivery be realistic and credible states develop their vaccination strategies based upon those estimates a change in those estimates has a profound ripple effect throughout the public health system not only does a change in the available the acting supply impact the scheduling of clinics it also impacts the plans for public information campaign any campaign encouraging expanded vaccination when the vaccine supply is so limited would likely result in patients becoming disillusioned and frustrated because of their inability to receive vaccine in addition to inability to provide the vaccinations will further undermine the credibility of the public health the media campaigns must be time to match the supply of the vaccine if more vaccine does become available in like november media campaigns aimed at encouraging more broad scale vaccination have a much greater chance of success and patients a greater chance of being vaccinated in summary while back and i should never have begun in alabama the reduced release of vaccine forces to develop an alternative strategy our long term vaccination success depends upon the continued interest of individuals and receiving vaccinations in december and january when vaccine will be more  closing let me thank this committee without the support of this committee we as a nation and certainly alabama state would be far less prepared or able to respond thank you again mr chairman members of the committee for this opportunity to share our ongoing experience with h one n one department of public health since one nine hundred eighty eight and labor health and human services education member he's here to brief us on h one n one rob director and operation of large full service public health and a t focusing on preventing communicable diseases promoting to help the children youth and their families protecting the environment reducing environmental health hazards reducing chronic disease and assuring emergency care and he does in many languages one of the largest hospitals in ramsey county has hand people to interpret up to forty seven different languages and he also has three many different cultures planning and women's health as well as a large family home visiting program serving over one hundred families a year we have three hundred twenty staff to provide these services and our budget in excess of two million we've been planning for a pandemic since the late one nine hundred ninety s federal funding to support our planning came shortly after the nine eleven event and then the october two thousand and one anthrax sure you're all very familiar with the investment that the federal government has made in public health emergency planning and especially in the recent public health emergency response funding has been vital to dealing with the current situation i can assure you that local public health as well trained and ready to be the ground troops in dealing with the h one n one pandemic in late april this year when h one n one first reached our community one of the biggest tasks we faced was getting accurate and timely information to our community about the threat of h one n one we immediately began providing the mitigation information to residents of the county on how to avoid getting sick wash your hands cover your cough stay home if you're sick the same messages we gave in the one thousand nine hundred and i make are still the most effective messages today as the h one n one returned flu return this fall is important we continue these messages until we could begin to vaccinate our residents one important aspect of this communication is how to reach the many limited english proficiency members of our community our department along with other local public health departments initiated a service called emergency community health or echo and this now nonprofit organization produces monthly health shows on our local public television in six different languages and they also have telephone message lines in twelve different and a website with information in the same language is the second major effort at the local level was to ensure that as many of the appropriate clinics in ramsey county as possible applied to receive h one n one vaccine while we have a large system clinics among our two hundred eighteen clinics we also have sixty three unaffiliated clinics including three federally qualified health centers are health care for the homeless clinics five school district and nine colleges with health services as the h one n one vaccine became available to us in small amounts our local public health department took on the responsibility of seeing that emergency medical service and other first responders not attached to hospitals receive vaccines one of the dilemmas was that the initial vaccine provided to us by the state was that we can live virus vaccine commonly called flu mist and this type of vaccine has some limitations such as a maximum age we have also become the distributor of antiviral drugs in minnesota has established a flu line and that can help to diagnose flu symptoms over the phone and prescribe any barrels to those persons who can best use them for persons who are uninsured or for those whose health insurance does not cover prescriptions the prescriptions are sent to our department and for the time these people can come and get the item virals without cost we are also the local stockpile of these an will distribute to our local clinics as they need them another responsibility for local public health has to be the pasta torreon distributor a personal protective equipment such as masks and ninety five respirators the supplies are coming from the strategic national stockpile it was distributed in part to the states last spring so how do we do all this at the local level we set up our incident command system last spring and reinitiate the system for weeks ago this is the formal system of managing emergency situations that we've trained in exercise for the past eight years as of today we have one hundred thirty five of our three hundred twenty employees that been assigned to some duties for the situation the challenge for public health is that these folks have to give up doing their regular work in order to meet the needs of the h one n one pandemic we do have some concerns obviously the delays in the delivery of h one n one vaccine are causing disruptions to our plans to vaccinate as many people persons as possible as quickly as possible we're seeing an increasing number of illnesses in our community and hospitalizations and we still have limited supplies of vaccine we know that the credibility of the entire public health system is in question due to the slow arrival of the h one n one vaccine the demand for this vaccine is high right now it's slow in arriving this demand may wane for example we're in to spending some  eight hundred doses of vaccine to focus on school children nine and under that we have over twenty thousand children this age range in schools in our county our challenge is to distribute and vaccinate in a fair manner so we cannot meet what will be the high demand for vaccine in children another issue is the delay in the delivery of seasonal flu vaccine well this is not an immediate problem it could become one if we don't see adequate supplies of seasonal vaccine by december minnesota's proud that we have the highest rates of seasonal flu vaccinations for persons over sixty five in this country but this will be more challenging to accomplish if the delays continue we anticipate that will be in the incident command system operations well into two thousand and ten this will have a real impact on the delivery to our other important services for example we're planning to move many of our home visiting services from weekly visits to bi weekly we are also planning to reduce the frequency of our food beverage and lodging inspections and we're very concerned that should we have another emergency such as a large scale food borne outbreak or tuberculosis outbreak where diverting our staff that will have problems covering that as you know local and state funding for public health has been impacted by the poor economy and we've just planned on eliminating five percent of our staff to and ten budget goals wellness funding that's now in the health care reform bills is critical to assuring a strong local public health and infrastructure for the future in summary local of the h one n one pandemic finds itself wearing many different have many of the jobs we're asked to are familiar tasks but some are not local public health workers are putting in long hours and deeply committed to serving our communities were influenza plan was to develop sufficient domestic manufacturing capacity to produce pandemic vaccine for the entire u s population of three hundred million persons within six months of pandemic onset w particularly barda and c d c have worked twenty four seventh's to address the h one n one pandemic we are falling miserably short of the school following the h one n one flu outbreak last spring the federal government contracted with its five suppliers of seasonal flu vaccines to deliver two hundred fifty million doses of h one n one vaccine to protect the u s population from the spread of the virus in the fall initial government estimates indicated that one hundred sixty million doses of the h one n one vaccine would be available by october based on information provided to it by the vaccine manufacturers later revised downward to roughly forty million doses by the end of october on october twenty ninth c d c reported that twenty four point eight million doses had been made available still sort of a lower estimate of forty million h h s data supplied to the committee staff indicate that doses sufficient to cover all correct as you point out there's no downgrading projections for the number of doses that will be available that number has continued to continue to decrease really through the summer and into september and october as of today s that a concern that some of the high risk persons such as pregnant women young children may have to wait several months to get the vaccine we're very frustrated by the vaccine delivery and vaccination becoming available after the emergence of a new strain if you look at previous pandemic vaccine production it has been really not possible to have vaccine available for the first vaccine without cutting any corners when do you anticipate there will be enough vaccine to cover the priority population we have been working extremely hard with each of the manufacturers to be sure that all of the stumbling blocks that we have any control of and that they have control of are really out of the way some flus really unpredictable and i think we're pretty hesitant about projecting forward more than you know week to week largely because anything could happen so why i think at this point we feel like more vaccine is coming out every week at this point creating sort of more expectation i'm not  think will be more confusing than anything else what have you learned on this site that when i mean why can't more vaccine be produced by the end of the year and i think it goes i mean to that to the timeline of the vaccine as well in the production sure so so on the site visits you know what we've what we've done is a couple of things and i might i brought along a graphic which which sort of might help a little bit to explain things but at this point you know the manufacturers the manufacturers i think have all made a lot of progress with their yield and their growth which is the the first step is really sort of growing this virus so that's what this really tries to depict is the manufacturing process in some sense as mr cured asked and where we've made investments that's the stuff in green in the stuff that i know you're most interested in down the left hand column in yellow so the first problem that you know everybody really encountered was poor virus growth  so the yield of the virus and so the yield the vaccine continue to decrease throughout the summer and into the early fall all of the manufacturers have told us now that are really through those at least for now again something could happen that could stunt that virus growth and that's one of the reasons that we're hesitant to predict one of the things that we did in the site visits was really to look at the production challenges and to try to see if we could work together to figure out where there are other production challenges but together we could overcome if one manufacturer didn't have enough filling capacity for example  could potentially help identify a source for them to fill in a contract manufacturer that was licensed in the united states and we've done those things we've shifted all of the vaccine manufacturing to the extent we can  vials first because they're faster to fill with leaving the rest left over as i know you've been interested in for the the single dose syringes so we've really worked with them shift everything they can do to get back seen out a fast as they possibly can and then a lot by luck we're tracking through the process so that to the degree even that when a lot is ready to be released to the manufacturer we actually have a truck waiting and pulled up at the loading dock ready to accept that vaccine and bring it to the distribution site so we've been working every step of the process to get any delays out and that's what the site visits have largely been about i have a question about the contract well you know we need to really have a balance between being sure we've got enough vaccine throughout the time that people need and want it and being careful stewards of society's resources here so the biggest issue first is to get the ball vaccine produced it takes four to six weeks from when you have that both vaccine to do what's called fill and finish to put it in vials to sterility tested to have it safe for release and ready for distribution and so we've gone ahead issues as you said and issued orders for the first hundred seventeen million to be put into files and actually this week are issuing more orders for additional vaccine so that we don't have a gap because of the delays in vaccine you know that hundred seventeen million is taking us further into the year than we thought it would and we will continue to to issue additional task orders in time to fill and finish that scene so that there is no gap in the delivery on the other hand we don't want to the very end of this to be sitting with a lot of vaccine already in vials that can't be used better to keep it in bulk form so that it could be used for example in the seasonal campaign next year or potentially available to for the developing world but please faster technology in this pandemic as we understand the cell based method it doesn't take as long to produce a seed strain it allows for a more reliable and sterile method of replicating the bag seen in cells rather than chicken eggs and have the added benefit of allowing the back scene to be provided to people with egg allergies and it can be made at least four weeks faster and in greater volumes than at base vaccine h h s has invested over one point four billion dollars for research and development and new facilities produce new selby's vaccine six manufacturers have received contracts for this work and one back manufacturing of artists is building of the silly in north carolina yet it appears that license i'll be expecting in the us is still at least three years away when might these new facilities obtain approval from manufacturing what actions can h h s take to expedite this process so let me let me say first that we're very encouraged both by the development of cell based technologies and other new technologies i think that are coming down the line and that we've invested in both from the basic science perspective from dr fountain and through advanced development through the bard and the first cell base picturing facility is now being built in holly springs north carolina by novartis and we've provided substantial funding to help with that facility and so that we will have capacity there to manufacture cell based axion when it's available for manufacturing our understanding is that right now that manufacturing facility will first be available to manufacture f vaccine again if all goes according to plan in two thousand and eleven when the vaccine will be licensed is really an issue of when the company is ready with the techniques with the manufacturing when the material we believe that cell back to tell based technologies will get us sixteen faster more reliably will avoid the problems with it based allergies as you said and i think we're very very encouraged by that i want to point out shy of half way to what our pandemic goal might be in terms of capacity to make vaccine for the entire united states so while we're really excited about the step forward we need to continue to invest in cell based technologies in additional manufacturing facilities and additional new technologies to take us even further into the twenty first century and to then be able to take those technologies to scale in large scale manufacturing in the united states could i just add to that so this is not confusion about the relationship between cell based technologies and other technologies that don't require the virus to grow so it is entirely conceivable that you could have a cell based technology that requires the virus to grow and it will grow very poorly in the cells so when you have to get the virus to grow there's no guarantee that you're going to all of a sudden get away from all of the vices based probably more important then being more quick quicker like three four weeks whatever is the surge capacity of cell  you can get all these vats of cells ready to go and when you need to make more you just pull it out and start growing it we feel that the answer to these kinds of uncertainty is to do the kinds of platforms that  we're doing basic research clinical research and partnering with the biotech companies to take vaccine ology from influenza into the twenty first century by not requiring the virus to grow there are so many of those different techniques one of them is for example to take the d n a that codes for the hema gluten which is the important component of the emitted unicity of this and inject it into an individual and have that person make a lot of immune response against that hemoglobin and you don't have to require the virus to grow anywhere you could just make that d n a and make it in unlimited amounts those are the kinds of technologies about five or six platforms so all those cell based is important and that's the next step which we're pushing for and invested a lot of money and that's not the end game for us the end game is to get away from requiring the virus to grow thank you using either cell based or any of these new technologies be more expensive and if so how will this affect both seasonal and pandemic flu prevention campaigns on the federal and state level that's a great question i'm not sure at this point that i'm able to answer whether they will be more expensive certainly there's a lot of investment research and development that goes into making and producing anything axion and certainly the more of it you make and the more of it use the lower the price gets because you have all those efficiency scales but i don't think that i could project that now in general new technologies when they start off turn out to be more expensive the molecular cycle as you scale up and really get a lot going and you get a predictability about how much you can order the prices plummet but right from the get go if you're starting with a new technology that's going to maybe take ten or fifteen percent of the vaccine requirement that technology can almost guarantee is going to be more expensive initially and then ultimately become much less expensive had had a just a vested soley in bringing on an approving new technologies rather than focusing considerable resources on a vaccine would we have had this new or faster and more reliable method for the h one n one pandemic you know hindsight is always a good thing and i'll confess that i don't have the hindsight to be able to answer that question you know things always take longer than they should have and i can remember we started and some of the newer technologies but you have to have those platforms ready and the techniques ready before you can even start to invest in the manufacturing facility and take it to scale having said that yes we could have invested more and yes we on so what that's really intended to convey first of all is as we all know right now we're still dependent on growing vaccine in eggs was a pallet of eggs so that's a pallet of eggs and what this is intended to show is that  until we have these new technologies we've had to invest in maintaining a steady supply of millions and millions of eggs here we started the supply contract in two thousand and four and so how many  is one vaccine or is it multiple eggs or one of the challenges as i think during seasonal flu vaccine and my colleagues can correct me if i'm a little bit off here but you can get it least sometimes more sometimes three doses of vaccine per egg but each virus grows at a different strain it a different rate for this h one n one i think when people started with the very first strains they were getting about point t point three doses and they've done a lot of work to change that so the bill increase the capacity to increase after passed by millions of eggs is the answer ok do we have millions of eggs now we have millions of it now and we've been securing millions of eggs and millions of chickens i learned when i checked into this job that i was responsible for many chicken farms well so if you're gonna look at a time line and you need to embryos at the same but you don't go to the store to get them it takes a while to order them well there we have a steady supply in a steady order now so that's not the hang up and that's because of investments made in two thousand and four but then when a new strain comes along what you have to do is isolate the virus get the seed strain is dr fetch a little too into his graphic and then it has to grow so that you can actually the average time or is there unique time just just days in fact this virus was isolated in california by c d c work that was ongoing to identify new strains before the mexican now so they're constantly looking for yes a mutation to the in the resource limitations that we have yes ok so we have once we capture that then do they have how do they grow enough to put into the a i want to take the first step is that c d c will isolate the virus  select a candidate strain that looks like it'll be good for vaccine and send that to partner institutions that will then change it to a form that is facilitates to making a vaccine it took us literally days to get that done after isolating the virus we provided it to partners to partners and provide it openly to manufacturers academic institutions governments around the country and around the world so from the time you isolate the virus we're about ten days two weeks it really varies because there are two ways to get you have to get what's called a seed virus in a reference strain and what happens is that there are two ways to do that you have viruses that are very good growers and adapted to exit a puerto rican strain younger so it would take them well they could take several weeks it could take a month if it does if you don't get a good reference trainer received virus i mean if you do it real quick and you're lucky you can do it days to a couple of weeks if it takes a long time to go months and so if you were if you were going to get one hundred thousand back scenes it would take two to four weeks to get ready to inoculate and then how long for it to incubate within the eggs  that that takes months and months and again that depends on how quickly it grows so if you have isolation within a few days you get that it takes a few weeks to get the reference strain or the seed virus you grow it up you give it to the different companies and they start adapting it to their egg system a would have a system they use if it hits the ground running and it's really a good growth you could start making that right away and getting yields within a period of a couple of months of getting the   i'm just trying to get my arms around you know what is the how how long can we expect this process to last to take and it's seems kind of nebulous now i can project forward that if i needed one hundred thousand vaccines at some point in time when would i expect those to be available you know when you order a product that has a delivery date what's the delivery date for one hundred thousand vials planning for the pandemic it always said six to nine months so from the day the virus growing you could not one hundred thousand off in a few days actually if you have a big plant but i think that the important issue to understand is that on a regular flu year where you have a reasonably good growing no glitches from the time you isolate the virus or make the decision of what you going to put in your vaccine to the time you get it in the vile ranges from six to nine months six to eight months that we can expect the same for h one n one we had hoped that that was the case and there were a couple of issues i think three issues and i i believe that was the question you asked right from the beginning that you wanted to get to so if you look at the time frame when you when you decide what you're going to do with seasonal vaccine usually make your decision around january and you start this process usually if it's a reasonably good grow it you get it what you need around the middle of the summer you start getting it ready to send out in september you get it down to the people who need it and then the flu season doesn't really hit you in earnest until the end of the fold the beginning of the winter and well into the winter so now what you have here is a process that started in april so right away the wiggle room for slow growth you have one foot on a banana peel there because you lost three months on the other end of the spectrum instead of having some c room for flu season to start the virus never left in the summer and it was just waiting for the kids to come back to school at the end of august and the beginning of september so instead of having the grace period of things really happening in earnest in december and january they happened in earnest at the end of august and the beginning of september superimposed upon that virus that doesn't really grow very well and you have a triple whammy you start late through no fault of anybody that's when the over general motors in a couple of days we took over the banking industry a couple of weeks so why can't we take over this process and get it to work right in a time line it's not fifty percent off you know three months one where the other that's a super of question and it's the question that's frustrating as well because the thing that really is out at this point in time with this technology which is being used for which there was no choice but to use it because that was the only available technology for this type of technology is difficult it is and we swallow hard when we say it you really can't do anything when you have a virus that's not growing well except trying to wiggle it around to get it to grow better so you really can't say well now we definitely going to have these amount of doses which is the reason why doctor dr lurie it said it's very difficult now when you have such a fragile system to make absolute definitive predictions and we are talking about the american capacity correct and we're relying on worldwide production for this and so how much less control do we have over the worldwide production of this we were talking about six to nine months for domestic capacity and does that or does that include the ability for australia which we contracted with and then they diverted their supply for australia not a surprise so we have limited capacity here and we have this sort of slush in the schedule does that apply to world wide or is it worse overseas with the interruption of production everybody has the same problem with growing this virus this is a global issue this is a global issue this is not something that's new to the united states w single but i don't think that's the answer to the problem the answer to the problem is the fundamental terrible growth of this virus early on i'm not involved in whether the virus or not at the end to those multi dose time is slow then why do we have a pandemic there's a difference between how it grows in the laboratory and how it spreads from person to person one of the reasons that this virus has spread so rapidly and affects younger people more is that it's unfamiliar to us so there has been a similar virus circulating widely in decades and that means that it can spread rapidly among people who don't have any immunity from having been exposed to similar viruses in the past so it's a strain that's unusual to our younger population now that allows us to grow so freely among kids under five i guess that's the what we call that group priority population was a priority population is the children are five and pregnant women five groups that are priority for vaccination one is workers who care for people with influenza and need to be protected the second is pregnant women who are at higher risk of third people who care for infants six months or younger because we don't give vaccine to in months or younger so we protect them by protecting the people around them the fourth is kids and young adults from six months to twenty four years of age were more likely to get the onus and then the fifth is people twenty five to sixty who have people standing in lines for hours trying to get vaccinated only do be turned away and in los angeles county for example about five point five million people fall into the priority categories for getting vaccinated but only about fifty thousand people were vaccinated in the first week after the county clinic opened and many were turned away because of the vaccine supplies had had run short now public health experts have  that once people are turned away it is very hard to get them back to to be vaccinated so my question is have the early supply shortages seriously damaged the goal of vaccinating all americans and where do you think the point of balance is between your public messaging intended to raise public awareness about the dangers of h one n one which raises the demand for the vaccine and the current limited supply of vaccine thank you as you point out any time someone comes to a doctor's office or goes to a vaccination site and there's not a vaccine available the likelihood that they return to that site is less than we wish it would be and that's why we're so frustrated not have the amount of vaccine available when people want to get vaccinated our goal has always been that vaccine should be of ala book anyone who wants to be vaccinated starting with a priority understanding that many people choose not to be that their choice there's no mandatory vaccination as part of this we're currently at thirty two point three million doses available for ordering and distribution it's not nearly where we would like to be what we can predict is that demand for vaccine will be dependent on multiple factors and how much disease is in a community how high profile that diseases and also an extent to which vaccine shortages tend to increase demand for vaccine we're seeing in this season unprecedented demand for seasonal flu vaccine even though the seasonal vaccine doesn't protect you against h one n one and seeing also shortages of seasonal flu vaccination the seasonal flu vaccine distribution system is done completely differently than h one n one is done ninety percent do the market and who manufacturers can sell to but absolutely the fact that there is not vaccine currently in providers offices when people want to get vaccinated some of those people who want to get vaccinated and would benefit from it in all likelihood unfortunate will not come back in the future and after the initial wave of vaccinations what will be the strategy to reach the rest of the non high priority population and how are you communicating that message to the public each state operates differently and we at c d c have provided with the support of the committee and congress about one point five billion dollars to states and localities for planning and administration a vaccine some states some through public vaccine clinics some through private provider offices many are doing school located vaccine clinics and we have some excellent examples of each of those things working very well but we've left it up to each state to identify the strengths within their jurisdiction and then to support them in doing that and i don't know if my colleague from alabama would like yes ma'am i think the answer to the the target populations we're trying at least in alabama we're trying to match the target population with the provider most likely to see the target population for example our plan for example originator reach children in kindergarten through twelfth grade reached out to our qualified health centers but and we've done that for all of them but then underlying that we also recognize that there are going to be patients who don't have a primary care provider who are in one of those target population that's why last week we held across our state statewide backs and nation clinics through our county health department will continue to do that our strategy is as long as vaccine is the limit is we're going to push back saying in the private provider community target population we're going to have a  underlying safety net of community health centers and public health departments to serve other people i think the concern is once there is enough back say whether that's like december or january then it's going to be the challenge of reaching out to people who have self deferred and not come in and alabama one of the things we've said is while we are trying to reach the target population anyone who gets in line we will vaccinate because once we turn them away we're not sure they'll ever come back that was the experience i think it was in two thousand and four or pre filled syringes there's no doubt about that that's filled finish issue the issue that we're facing is much less a delay in field finish than it is a delay in how the virus grows so that's the s maybe jump in and add to that when it began to look you know earlier on in in the fall and maybe even earlier than that i can't recall exactly the dates that we were going to have this low growth and fewer doses of vaccine we work with the companies pretty quickly to say they do everything you can to maximize the number of doses that get out there quickly garbus of whether that's in a prefilled syringes or multi dose vials the fastest thing to fill is a multi dose vials that has primary saw and we asked the companies to differentially first bill as much as you can in your filling lines that use multi dose vials if you have stuff left over by all means put it in prefil don't hold up the number of doses that we're going to be able to get out quickly because of the need to filter prefilled syringes so from that perspective yes it had a little impact i think it had very little impact we're going to have to resort to both will be doing research and investigation out there working everybody's out there doing the best that they can if you could just walk through what is a public private partnership that you keep referring to that you went out and you and are they back on track to get caught up because this was this is that the federal government does not have a vaccine plant where the three of you were overseeing the eggs and and making sure the about possible shortages for the regular flu virus that's a lot of very good questions and let me take a stab at this meet this is a public private partnership much of vaccine development therapeutic development others are all public private collaboration of one i know there's a pretty substantial investment in the basic science of doing all this and the clinical science of this much of that investment has been through and   i'm sorry the administration this is a targeted amount of acting that they thought they were going to have available and why didn't it is not available it's not available it's and it's not it wasn't anything  that any of you or anybody in the federal government had any control over that's radically right that's exactly right and largely as i think we've talked about before the break the biggest problem had to do with this growth of the virus in the experience historically with the with the growing virus was very different than the experience with growing this particular virus and that's why we need to get away from making vaccines that depend on this to grow it so thank you so when people are out misinformation saying the reason why we don't have an air vaccine is because of government takeover and because the federal government and you know you can't trust them with your health care what kind of effect does that have that has a trickle down effect on this kind of misinformation repeated over and over and over again and there is a shortage because the manufacturers the private sector didn't deliver as much as they thought they could originally on time mr fulton and in your colleagues what kind of effect does that have with all the other messages you're trying to get out to reinforce that when this misinformation continues is repeated don't trust the government when they tell you something about what we usually talk about don't trust the federal government  one local public health is very much in the business of communicating messages to people and when our messages are inaccurate that lessens our credibility and when our credibility is less and th messages that we're getting out about you know don't smoke and exercise and things like that are tainted by the fact that we have bad information we cannot control the  media we've learned that from a long time ago there's lots of messages that come out i have staff come in and said gee the other day i heard somebody on the radio say that you don't need to have a fever and still have h one n one well that's not the message we're getting out messages this is what the h one looks like when you get it but there are lots of poor messages out there and we try to do the best we can if we have to tell people we don't have axion that as i mentioned in my remarks that's going to affect our credibility and i would just echo that the i think in this specific circumstance my concern is that our inability to deliver the vaccine on the schedule that it was planned have to affect one is that care that undermines credibility and it leads to people also questioning well if they didn't produce the vaccine when they said they would they would is it really safe and then the second thing that i worry about is our ability to deliver this vaccine later in the influenza season when historically people aren't looking for a vaccination happened because the drug companies in good faith contracted with the government to get a certain amount of doses for the flu season with that comes benchmarks of when you think they'll be delivered the fact that they're not has to do with what we've said over and over again during this discussion mr chairman that the virus doesn't grow very well but the one thing that i think would be a misrepresentation and unfair is that it's their fault because it didn't grow very well it's just the nature of the biology of the virus that created an expectation that we thought that would be a certain amount that expectation was shared with the american public and there's a disappointment that's frustrating at all but i would to focus adopted lurie because she actually mentioned it in her opening statement and it really deals with the issue  patients and i think you references i know it's in your written testimony would need to receive the enroll nike lation intravenously and my question to you is pharmaceutical company in alabama full disclosure not in my district but in my home state that produces the drug part of there that i believe you mentioned in your written statement which is designed distribute to eligible entities and so my question to you is can you speak specifically about the emergency use authorization for this drug and whether the courses  is what you give to people once they're sick to prevent further complications most anti virals or all there's never been in the form of an anti viral before and with the has shown a lot of promise it's been available as an investigation a new drug sort of on compassionate use while but hasn't had really really large scale use and people yet and so there's not enough accumulated experience in data for it to qualify for full licensure yet by the f d a the company is still putting that material together in clinical trials getting that experience however there was a clear judgment made that there was enough experience with it clinically and with the safety profile given the severity of disease people were getting it could be available under emergency we've bought an initial number of doses but we are vailable prepositioned as opposed to being where i understand they currently are in a single location in maryland congressman i think i can only answer that based on our experience with the existing stockpile the existing stockpile having the stockpile available admittedly that's an f d a licensed product having the the stockpile available allowed us to push out one hundred thousand does i think if there is a benefit that benefit would be it shortens the time from demand to the patient and that that to me would be if there is a benefit for that being prepositioned in the states it would be if that in some way gets the drug more quickly to the patient i think there are issues obviously about who's eligible in those sorts of things that would have would have to be worked through but that would be the only advantage there's a pretty good system i think now is in place so it's a clinician recognizes that the patient is doing badly and that they might need a drug they can actually order this through a web site there are people at the other end also to answer questions that information is very rapidly transmitted electronically to the warehouse and those  and shipped directly to the point of use and as dr lori mentioned there's an website from mine ordering as well so it can be done very quickly thank you very much mr chairman and i apologize for coming in and out but while times i want to thank you so much for calling the briefing and all of you are here today to help in lightness through this briefing i'll try to get to three questions fast given the time allotment as opposed to yesterday the washington post had a in the last years of article regarding what's happening at the ground level in doctors offices and with pediatricians the article pointed out that the system for distributing it to private doctors offices is opaque and that it's not clear to the public or the doctors who is going to get what when so what is the delivery system for doctors offices who decides who gets what and allocate to school public clinics hospitals private doctors offices based on their best judgment of how they will get as many people as promptly as possible and that so then it becomes a state's decision to deal with this and how it is ok i'll get back to the i'll get to the seasonal flu issue in a second but let me ask this question because we have these hearings now h one n one is there a plan about i'm talking about infrastructure you know we talk about roads we talk about bridges we talk about modernizing our schools we talk about broadband all of these efforts of how we try to take this infrastructure and build you know for  the for the future here what is the infrastructure federal local level that includes and where industry fits  here that will not have a to have the same hearing over and over and over again it's all a bit like groundhog day because we're always some sort of a shortfall we don't have enough of this what is the infrastructure what would it cost how do we adequately prepare and have an infrastructure in place to manufacture and to distribute vaccine when ever something comes up here for us to have to deal with it so that we're we've got a structure in place to move forward from my perspective at the moment it seems to be that it's  questions over and over again having to ask the questions over and over and over again thank you very much i think if we start with the delivery system and work backwards we first need to ensure that at the local and state level we have the infrastructure you've heard earlier this morning of the enormous challenges that exist there we provide some resources guidance training and staffing for to support the work of state and local health departments but nowhere near what is needed that infrastructure is needed to deliver any tool that we have available do you all have a plan as to what it would be how would it be and what are the reasons i would guarantee and i don't know if i'm speaking just for myself but i think i speak for that when it comes to this kind of an issue i committee is willing to put resources at disposal here in order to get to where we need to go when it guards the public health if you don't have it i would welcome your having this kind of information to get to there a variety of estimates of what it would take to strengthen the state and local capacity in terms of tracking capacity the laboratory capacity of the workforce needs those would be the three key areas at the state and local level at the federal level there is also a need to track diseases better both in the u s and globally this disease emerged globally and much of our information of how it's going is dependent on what we can track globally so there's a need state local federal and global public health infrastructure in order to track and respond and deliver vaccines deliver antiviral monitor the course of the epidemic upstream there's a need as dr lurie outlined of investments in new technologies so that we can get out of the era and into an era when we can respond within weeks or months to the coming of the there variety of promising potential which is we seem to only invest after there's been a crisis well that i know you had to get ahead of this i'm asking really really to provide us with what is the investment plan and what's involved who is involved then it becomes  you will look to us and then we have a responsibility to deal with it and we have to get back to that at sank you thank you thank you very much mr chairman and this kind of discussion is not just overdue but very welcome during the brief time i had a chance to hear the committee i got to know some of the people who work with the privilege of working had the capability of being very virulent but was very very poor in spreading from person to person if at all there are only less than five hundred cases in about two hundred seventy deaths so it's still smoldering but in our preparation  pandemic influenza preparedness plan mr laro that you're talking about was to do the kinds of things that actually were in place which really did help us to respond as best as we could to this but we're not really there where we want to be but in specific answer to your question mr lewis we made a vaccine against the h five n one and the issue was is that it wasn't particularly good in inducing a response it's in humans so that the dose that was required for that particular vaccine was outlandish it was ninety micrograms times two which would induce a response in only fifty percent of the individuals when i was making my presentation i was saying that fortunately the h one n one vaccine that we tested at the end i h a standard fifteen microgram dose induces a very robust immune response with one dose in virtually everybody except younger children so the frustration is we don't have the vaccine available right now for everyone who wants it the good news is that when we get it into people and family who was pregnant get the vaccine and it was not available in this environment and so they found themselves standing in line over the weekend for some considerable length of time and that's prob itself just a waiting line but it's been a second group worries me a lot that's two grandchildren who have in a family where the mother has suffered from asthma who should be vaccinated for the children or the mother  you've identified three key groups to get vaccinated and from c d c we've said basically that all of these groups should get vaccinated even though there's not enough vaccine for everyone who would want it now we don't want people turned away and told to come back because they may not come back in the future there's different reasons to prioritize each of those pregnant women because they're at higher risk of hospitalization and people with asthma because they're at higher risk of severe hospitalization and kids because they are a higher rate of getting the disease and risk of getting aids in africa and she said that it was good that we had an interest in impacting that it would indeed malaria in africa was perhaps a greater challenge and for the first time mr chairman i heard about d d t and the impact it had on malaria here and otherwise and we we banned it for this country but she's essentially said that is has a capacity for staying time lifetime in the hearts of villages in africa i that struck me as being amazing is a lot better than that depending upon netting but is that a reality are we are they using the yes there is a plan now of doing multiple things one is insecticide impregnated bed nets the other is spraying indoor along the rim of the huts not globally out in the environment but in the or in the huts on the fee other is prophylactic treatment for pregnant women and the other is autumn ison in combination therapy for malaria those are the four components of what originated as the president's area initiative which is being continued in this administration and those components are highly effective  in country in all of those places working with health ministries in places which have implemented those four components well have been able to cut malaria deaths by fifty percent or eighty percent so i've asked a follow up by sources in california but it might be better to mentioned one of them is the growth you can get contamination etc the plan is to move to a much more reliable cell base but still requiring the growth of the virus which doesn't eliminate all the fragility of the system the endgame for us is the investment which we're making and the ability to scale up in the arena of molecular techniques let me give you one example of a molecular technique that is probably the more advanced of a group of about five or six that are being pursued it's everything from the fundamental basic research at the end i each up through and including partnership with the companies to get it and that is instead of relying on the whole virus to grow the part of the virus that's the him in the genic part that you want the body to make and units sponsor against is a thing called chemo gluten or h you can take the gene of that and you can insert it in a virus that happens to infect insects it's called a bacula virus that virus then you grow it in insect cells and you can have a great deal of control of the amount you do in the process of applying to the f d a for licensure that's the good news the challenge ahead is how do you get that technology to be scaled up enough to essentially replace completely the fragile technology so what we're going to be seeing the stuff on there over the next few years and it's going to take years because that's the nature of the process as fast as you go is a gradual transition from egg based to egg based together with cell based to cell based to advanced molecular technology the ultimate end game for all of us and where we're aiming our research at the end i h is to get what's called a you know versatile vaccine a universal influenza vaccine is a vaccine that would induce a response to a component of influenza that doesn't change from season to season and that doesn't change whether you have a pandemic strain or a seasonal strain and that if you can do it that would be the end game you mention that you still are the end game because then you could make as much as you want you could store it you don't have to change from season to season and you could inject people get them immune immunized and immune and protected and then perhaps every few years thereafter do it again that's the plan that's going to take years seems like influenza a it could be a pandemic it could be a seasonal it could be an eight three and two and h one n one it's still influenza there are parts of that virus that the body doesn't seem to make an immune response that i resolve it to slight changes what we're doing now is identifying what we call cryptic components to put it in a form that when you vaccinate somebody they will material some of the test by one of the things that struck me perhaps not accurately as dr laura maybe but anybody can take the question was how much of our product that we need is dependent upon foreign manufacture so one is that correct problem to one of the reasons why so much production is elsewhere as opposed to challenge sure right now more able to fill and finish vaccines but not make the antigen in the united states that's a historic problem that had to do with investment in the vaccine infrastructure that profitability is making flu vaccine  clee hasn't been very profitable when this problem was you know as several years ago a couple things happened we took very aggressive actions to get manufacturers licensed even to sell vaccine in the united states and then aggressive actions to rebuild the manufacturing infrastructure within the united states precisely because we don't want to be dependent on a situation where everything we need to protect the public realty that's going to open or begin start up next year and it's having an opening this fall but that will only get us for cell based maybe only half of where we project we need to go to be prepared so we need to continue to invest in that large scale manufacturing capacity in the united states but with our eye on the end game so that when we have the new science where then another five years behind with scaling up to manufacturing capacity so that's going to be a continuous process for a while and it's going to take some substantial investment second question obviously all of us i know you more than one else somewhat disappointed that we put out information that we weren't  to fulfill in terms of commitments when along the process did you begin to have a sense that we were going to come short and what if anything differently should we have done in terms of trying to lower the expectations game  guess one of the challenges that you have today we all have well i think it's fair to say that there are a variety of points along the way where we got information that are met a vaccine was going to be lower than we initially anticipated it every step of the way we looked at that information communicated as quickly as possible to our state and local partners and to the american public so we've tried to be and i think we have been really transparent about communication and there's been multiple points along the way were different things went wrong you know whether it was about virus growth whether it was about problems with filling lines or other sorts of things so each step along the way we've tried really hard to communicate that to the american public and you walk a really fine line i will say between needing to be really transparent and satisfying everybody's needs for projections and ending last question i'm sure just like the military after you go through an exercise like you're still in the midst of you do a lessons learned what will we do different one what's the timeline for that and two is that something within my office and i think really across all state and local levels we need to do that because we need to be better prepared for the next time and we're always asking ourselves what could we do better what could we do faster what did we learn  all this thank you very much let me make a few observations and ask a few questions first of all i forgot whose testimony it was that indicated that we lost about fifteen thousand public health  personnel in states around the country i'd like to simply point out that occurred despite the fact that we put billions of dollars in the stimulus package into efforts to stabilize state budgets and as a result that package this year has filled about forty percent of the state's budget holes the problem is that next year the remaining funds in that stimulus package will only fill about twenty percent o state budget holes so we're going to have a problem at the state level in terms of budgets twice as bad as the one we had this year and if we don't do some about that we're going to lose a whole lot more people not just public health personnel one observation let me ask you the question will the delay in this vaccine vaccine which delayed somewhat the start of production of this vaccine all right you've all been very reluctant to make any further predictions about how many doses you're going to have when let me ask you what might appear to be a cynical question  are we going to have an appreciable amount of this vaccine delivered after the second round of the pending i'll have the flu hitting people is over i think there's no question that currently we're continuing to see virus activity didn't the number of people getting sick increased in many states although it has already begun to decrease in other states particularly in the southeast so it is likely that the current wave of infections will crest and begin to decline before there are ample supplies and whether there will be another wave of h one n one between now and when flu season ends or whether we'll get a different strain of influenza only time will tell it appears that we have relied upon the estimates of manufacturers in order to determine what our expectations were in terms of the availability of vaccines have have you been able to develop in any way a process which will enable you to make judgments that are independent of the estimates of the manufacturers with regard to that question we really are dependent on the production facilities to tell us what they can produce and dr laurie may want to know i would agree with  and we're very dependent as you've heard a lot about to do anything and in fact even with making projections early and making assumptions that even then they told us we still got into the spine once that stuff is made as i said we are tracking a lot by a lot every step of the process so from there on developing more comfort but not complete comfort are you satisfied that the manufacturers notify do immediately after they got their first inkling that things were going to be developing more slowly than expected you know we've had communication with the manufacturers every week and there's been a really good exchange of information throughout this process so the answer would be i mean i we don't obviously nobody knows what they don't know but i've been i think that this has been a really good collaboration and that there's been a very good exchange of information let me ask about respirators according to documents as of june two thousand nine shifts wouldn't this number seem shockingly low what's the rationale for stockpiling the low number of n ninety five why not more global production capacity for ninety five cannot keep up with the demand that would be used to comply with the c d c recommendations for use of the ninety five health care workers caring for people who might have h one n one influenza the stockpile is meant to address not just influenza but a whole range of infectious disease conditions that might benefit from respiratory five global capacities and adequate what can we do about in the guidelines that c d c issued we outlined a series of steps which health care facilities can take to preserve and limit  the use of n ninety five so that the highest risk procedures and the highest risk situations we have and what is what is going to we do to boost the capacity for production it is only recently that c d c has recommended use of and ninety five patients for health care workers caring for patients who may have h one n one influenza this has big implications for supply and for the market and i think as we get through this flu season we need to look at what the  stockpile should or shouldn't have looked just one last point i'm not especially known around here for being patient and  i've been here and stuff for five years and i just want to quote a couple statements from hearing transcripts in two thousand and four and two thousand and five asked is there something the government can do to help regularize the annual vaccine supply that we have for instance could or should or could the government simply guarantee a specific level a level of market to manufacturers in order to make certain that there's enough incentive for producers to produce it year after year and i went on to say it seems to me that if this is a crisis i don't understand why we cannot bring the lead countries of the world together government governments and industry people find out what it would take to develop if its physical facilities are necessary and i understand you can't do it instantly but there must be some way to compress the time frame of we regard this as an emergency rather than merely an interesting problem in response dr gerberding said i have to be frank here our capacity to develop and produce vaccines for any infectious disease is extremely fragile in this country we do not have  excess production capacity for any one of the vaccines let alone in full ones the entire global production of flu vaccine is two hundred ninety million doses a year so we're a very very fragile situation in terms of vaccine supply i think we need to work with the committee to identify ways that we can motivate and expand our overall vaccine production capability this is a catastrophe waiting to happen we are at a crisis point here in april of two thousand and and i would simply say that the numbers that are being cited demonstrate our existing program is totally inadequate and not doing the job dr gerberding responded so i think this is a real opportunity for us to collaborate and really identify you know in five years where do we want to be and how are we going to get there and how fast can we get there now that was five years ago and so i mean i heard vaccine technology and we needed to do more to regularize demand we've been hearing that for five years i know you're new on the watch but what is it the way of resources that this committee could provide over the next four years so that we aren't flat john and yap and at each other using the same talking points that we've heard for five years what do we do how much do we need if there's something we can do ask us for us tell us what we need i mean we're spending lots of money on lots of other stuff in this budget that is much less important than this this little may wind up being not nearly as severe as we feared but by god some time in our lifetime that it won't be the story so what do we finally have to do so that we don't chew the same cud here after year after year thank you mr chairman for your question i think that is the essential question that all of us have to address and it starts with as you said i believe in your opening statement are pipelines that are rusty and we need to strengthen them and we need to recognize also that some of the basic science is a question of what's  possible it may or may not work out but with more investment and the like and let me say i understand i mean nothing has bugged me more in the over thirty years i've been on this subcommittee than to listen to people say oil of we could send a man to the moon we ought to be able to cure cancer it was a relatively simple engineering problem in comparison to dealing with the multiple kinds of cancers that are out there so it's a whole lot more complicated but having said that  if we were to make this a top priority what would we do what would our budgets look like what is a reasonable scientific expectation if we do a b and c what are a b and c that's asking i can address the delivery system reasonably well that we have additional resources for epidemiology lab the vaccine delivery at federal state and local levels we can ensure that we can get vaccine out which does our government have a five year plan to try to accomplish that or two i don't want to sound like the soviet union where this five y five year strategic plan where the science is and come back quickly to get to put together a new five year strategic plan and work closely with you to see if we can make progress in implementing it that you know we have been working with each other on this for a long time and i was there when you were reading all of this testimony from the n h standpoint as you well said when you were saying it fish with science it's very very difficult to predict because science is discovery it's not engineering but we do have a plan so i was saying the trip to the moment was yes i mean it's science of discovery and the trip to the moon is engineering and discovery requires the kind of basic science input that we have and that you've generously supported we have gone and from two thousand and three our budget for influenza was fifty million dollars it is now two hundred sixty million dollars at a time when the and i budget was flat so we have read prioritized for this emergency even though all science feeds upon each other we've made a significant with my local colleague from the rusty end of the spigot where we're trying to deliver the vaccine one of the challenges we face and i may be very clear were it not for the funding that you have provided to the state and through the state of the locals for emergency response and recently through the public health emergency response dollars we would not be here having this conversation because it would in many states be almost no infrastructure with which to respond so the first thing i would would would ask and i don't know the number but the first thing we need to do is to accept that there is some minimum level of infrastructure support that's going to be necessary at the federal level all the time because state budgets have these fluctuations and the other message that i think goes with that is whether or not the epidemiologist is tracking influenza today they certainly may be tracking a food borne outbreak tomorrow so there is that cross utilization and the other thing and i can speak from alabama's perspective here we need almost a hill burton or interstate highway project across the country to replace some of our public health laboratory infrastructure some of the public some states like virginia have done wonderful jobs in building new labs but many of us i state for example we're dealing with a lab that was built in the one nine hundred seventy s and that's fine they do great work there but it was designed at a time when public health wasn't changing the work they were doing this fairly constant and it was designed to meet that timeline so forty million dollar investment for the state we can't do that so we need that sort of bricks and mortar capacity construction going forward to i would like to speak to your question and the still ours point about the shortfalls the health care reform bill and its wellness package that a billion dollars a year for infrastructure and local public health and state public health will be critical to our continuing to have the capacity to be on the ground when these types of events occur i'm i don't want money just to hire people to sit around and wait for a flu vaccine flu that i need the people to be healthy educators and visiting nurses and clinics staff and that piece in the health care reform bill that is critical and hopefully is not one of the things get tossed out at the end much like what happened with the stimulus money in the negotiations in the first stimulus bill chairman yes one quick question i hope that's isn't too far off the direction of h one n one  but it occurs to me that that while these are dedicated health professionals dealing with a profound problem in the system and there are problems that we are discovering in the system i'm wondering is this the same infrastructure that we would rely upon if this were a man made biological event would we be calling essentially just professionals yet tell us you have were there adequate preparedness the same but it's a sign it's the same so this were a manmade biological event we would be going through the exact same contracting that you're looking for to determine private sector influenza or vaccine producing into teas to distribute to the american people and that we have trucks lined up alongside these entities trying to distribute them to distribution centers throughout the country and it just appears to me that the inadequacy of a man of i don't want to say that our response inadequate because i think that in your testimony each of you have shown us that we're doing the best we can given the late ness of the mutating nature of this particular event but my concern is if this were a manmade biological event either through a terrorist event or something created in a laboratory that we wish we didn't discover would we be relying upon the same infrastructure to address  distribution mr chairman thank you well at the local level yes we're trained on a variety of different responses it could be a hurricane it could be a tornado which happens in our neck of the woods  could be an outbreak of tuberculosis it could be an anthrax attack we have practiced and have been trained in a wide variety of those types of events and it would be the same work force that's not all deployed for h one n one that would be deployed to provide the services for things like another terrorist event and that's certainly true at the state level for example in our case we're using a platform to monitor bed availability and influen like illness that we actually designed to monitor bed availability during hurricanes and used it during katrina to route patients from our southern part of the state further north so that patients coming from mississippi and louisiana would be able to be  hospitalized closely so in that sense absolutely it's the same epidemiologist we're going to be tracking whether it's anthrax or whether it's h one n one it's the same laboratory doing different tests perhaps but same laboratory the same laboratory capacity or lack there f that we're replying depending on and so yes ok well this direction you remember we had this conversation at one of our appropriations hearing and in fact it's exactly the same technologies that we're trying to develop and i can only speak from the research standpoint not from the you know from in the trenches in the community but from the research standpoint we make indistinguishable a manmade biological event and a naturally occurring and in fact in all of bio defense plans we actually merge those two and call it you know such and such for bio defense and emerging infectious diseases nature in my mind is the most effective and the worst and most dangerous bio terrorist and how you respond to it from a standpoint of the development of vaccine platforms is indistinguishable from what we would do to try and isolate an agent that someone deliberately released how we would characterize it and how we would try to make a vaccine so the answer to your question which is a very good question is absolutely yes we were doing the same thing from a fundamental research in clinical trials standpoint and i would very much concur with my colleagues our preparedness planning we try to make all hazards you know whether it's natural may or manmade whether it's a weather event or a pandemic a large many of many of the things you have to do to respond are the same and at the same time we're working hard to do the advance development to have flexible large scale manufacturing capacity so that when we need to produce a new kind of countermeasure guard most of what it is will be able to do it but we're still dependent on where we are with the interest the same technologies the same workforce all of those kinds of things from the public health perspective also want to say if you want to be able to respond to an emergency like this you've got to be able to do it day to day and one of the concerns is the more we whittle away at this infrastructure whether it's at the local level or the state level or at the federal level the less we'll be able to do that back to mr lara's point about really needing a huge infrastructure project for this country absolutely it's the same system in fact the granting mechanisms that are used for preparedness and response terrorism that have been used to funnel money or provide money to states and localities it shows the wisdom  of all hazards approach to dual use approach if you want people who are addressing problems today to get in the practice of doing that both so that you can have them well practiced and also that if you don't have an emergency or takes a couple of years you're making actually use of that money in those resources to protect people's health day in and day out i think it's also important to point out that many of the investments that we've made in preparedness really have been if it's in day to day public health practice and i don't want us to lose sight of that so it's not just if nothing happens even if i look at the use of incident command and public health so many health departments around the country now use this to routine outbreak investigations and they tell you that it goes better and faster and you can find example after example after respirator is more effective than a common surgical mask this isn't an area of considerable debate and discussion the c d c and the department of labor oh sure requested that the national academy of science medicine take an independent and rapid review looking at that specific question and without reference to feasibility or cost the institute of medicine or i o m did that review and recommended two things first the use  of n ninety five masks given the level of uncertainty with theoretical reasons that would suggest that they may be superior and second conducting additional radically nominally look better more highly taxed and so but we really don't know if we could use common surgical masks as least as a backstop correct in our guidance we don't know what percentage that is better than or worse than in ninety five that's the same in our guidance we give outlines of what can be done if and we got a problem getting back to listen to all the all the hole here and i just don't know how many we need how many do we need we would like to have enough vaccine so that everyone who was not be vaccinated does that one million is a hundred million three hundred million to meet a friend on demand million and how many do we have on hand today thirty two point three million thirty two point three so thirty two so we need a hundred and twenty seven million theoretically only in the best of situations we get about a third of people who are under sixty five and about two thirds of people who are over sixty five get vaccinated against seasonal flu each year so what do i take away from one hundred twenty seven million that we need so much to take away because of that i think well of it  not all of it is that we do need something right so maybe i can come at this from the other from the other perspective when we started this we said that we would buy or put in orders for another sixteen to get ultimately to about two hundred  when we thought we're going to need two doses for everybody now now it's less because now we know it is for everybody and so we always want to be is ahead of ourselves when the production catches up in energy and that's a big vats and figuring out how much we need to fill and finish and put in vials based on the demand and always have enough of eventually and that the goal is to always have enough to meet that demand we also want to be in a situation where we're good stewards of society's resources and so the best way to do that is to hold a bunch of those in that boat form not involved in toll we can anticipate that demand and we're going to need it because then that vials as we can until we get a signal that demand is really starting to drop i can see why this has i mean reporters are having trouble not saying that this is a crisis it's like we can't define what we're going and so we don't  worse i think as dr laura said we're making as we're telling the manufacturers to make as much vaccine as they can safely as quickly as they can but we're telling it we have five manufactured one in america none of them owned by american companies some of them are in australia owned by australian companies that have diverted their supply and i can you see the reason why people are a little bit uncertain about this none of these are controlled by american manufacturers s of the one manufacturer in america is actually owned by a french company what if the french said we got to have that stuff shipped over here we are left with what for a fallback i mean we've made it so difficult for an american company don't want american pharmaceutical manufacturing capability for this vaccine that we pushed it all over shore either in ownership or in physical location so i can understand why people are very upset and it's not just the fact that we have enough government money at this we spend lots of money is the fact that we've got a structure in place created by our federal government that makes it onerous for people to manufacture or have a facility that manufactures this capability in america we started to drain the swamp i don't think we're after the real problem here i mean we're just we're responding to an emergency again and mr robey made this but i think there are some underlying structural problems in our economy that have put us in a situation and forced manufacturing overseas or to a foreign owned and a t and i think until we get to the root cause of that we're going to be in this problem five years from now until you're sure around fifteen years from now we'll be dependent on somebody else as a society will be dependent on some foreign  government to say ok you guys can have some now do you see any other way about i mean a french owned companies are only geographically based in america manufacture is that not correct that is that is correct but let me also just so that people don't have the mis conception that the french government can you know suddenly decide what the australian government that's because it was being manufactured in australia they're saying that if they did the french government did tell me you got to send over here we could stop it at the border if there is something called the defense production act that would ensure that that vaccine would stay in this country and part of the reason that we really need to have the manufacturing capacity in this country is so that we can manufacturers that if they did locate in this country and if they did produce that they would have a purchaser of last result of last resort so that they knew that they wouldn't be stuck with millions of dollars if there was no demand in any given year duck in the one facility when we asked them to manufacture stuff for we waive any liability on their part and i was just watching t v last night there was another ad saying if you've been harmed by this drug call this number and there's a lot of advertising going on about how we can get to these drug manufacturers and sue the pants off them so when we ask people to do something like this which is you know is rather vague in whether or how many doses are needed and what the side effects are mean we just kind of go in percentages and more than fifty percent less it's not risk free and so do we give them any liability waivers for this or do we just we do so yes so these manufacturers will if we give them liability waivers it makes it easier for us to make things in extreme right now is a good point very good point and i think that goes to the underlying causes of why we're in the situation we have forced manufacturing overseas because of liability because of a tax structure because of regulatory structure  that's onerous because of our energy inability to be energy independent and then we wonder how we get the situation to say well we didn't throw enough money at it we put a structure in place over the last generation that has systematically force jobs overseas not a cover for it we're going to give these guys lab liability protection but that's just one of probably eight different or twelve different things that have caused people to make the conscious decision as stockholders to not invest in america because it's just too costly it's just too difficult it's just too hard so instead they move their production to australia or someplace else and not knowing the complete history i can take your problems i can't see the complete history but that's the bottom line is we have done this as a as a government we've made it so onerous for them to make stuff here in america that now in order to keep what we've got and to get them back we have we have to waive the liability requirements one of the many infrastructure problems that we need to correct and that's the job of congress to correct it not you guys i appreciate what you do and the government could set up a compensation system to assist anyone anyone who had been injured by buying those vaccines i think we have i appreciate it has been very useful thank you