commonly known as swine flu was reported in mexico several people died and the virus spread quickly just three months later in june the world health organization declared that this stra swine flu to be a pandemic the first global pandemic because aired since nineteen sixty eight according to the c d c by the end of august this new virus had spread throughout the united states resulting in more than nine thousand hospitalizations and over six hundred deaths at first some scientists fear that this could be a pandemic this asked on the scale of the hong there is great uncertainty about the cause of this flu and it is this very uncertainty that i think concerns people most if there is any good news it is that so far this flu strain has not caused the number of deaths that some had feared but why what did the experts see then that they are not see today and what does this foretell regarding how this virus may be a although dangerous move taishan these have not yet occurred is this still a possibility what does the experts expect and what do the best assessments now suggest covered health officials believe that vaccinations is the best means to protect against this flu we understand that a vaccine has been approved and is in production but every sense the swine flu vaccine fiasco of the late seventy's people have been cautious today we want to discuss questions that i believe the public has about the benefits and risks of the new vaccine we want to understand whether it is necessary whether it is available who will get it and when will they get it the more information that can be made available regarding these questions the better the public and other key stakeholders can assess both the risks and the benefits of receiving this important vaccine with the swine flu virus spreading rapidly hundreds of thousands of health care workers many in my state of new york are now being required to get flu shots concerns have been raised about mandatory immunizations and fact there is a protest underway right now in albany new york which highlights the concern that some have regarding mandatory vaccinations i want to carefully examine these concerns today with our witnesses and find out as to why in addition the chamber of commerce estimates that during a normal year united states businesses lose an average of ten billion dollars as a result of the flu it could be double that this year and many businesses that are not adequately prepared may not be able to function given the number of workers that could be absent fortunately we have the three leading experts on these issues with us today and we happen to have them i welcome all of you and i look forward to your testimony i will now you to my ranking member mr dallas's of the state of california for his opening statement thank you mr chairman thank you for holding this always timely hearing today we will examine the h one n one pandemic flu and many will say we're not examining it for the first time and that is true as a matter of fact we are not it and other causes a pandemic outbreaks for the last time or the second last time or perhaps the thousand last time it is very clear that the flu virus can mutate as it m grates it has in all the years since the many outbreaks including the so called spanish flu that was so devastating to our soldiers from fort riley kansas two generations ago unlike then we understand now that there are steps that must be taken today will hear not just about the virus and not just about vaccines but about a series of steps that must be taken now and in the future in preparation for an effective response if we have an effective vaccine today we have it for today tomorrow is yet another day and those vaccines that work yesterday likely do not respond next year moreover this committee has previously talked about and heard witnesses on the the annual flu shots people receive in the question it's about that this committee was very very involved and properly so in the provisions of the public readiness and emergency preparation act or the acronym perhaps act which in fact went a long way toward creating an environment in which our government could encourage the development of these vaccines at great cost without the liability being beyond economic advice of their counsel we must continue to do so we must work on a bipartisan basis to recognize that for example the veterans administration which plans to make available more than three million h one n one vaccine doses this year does so to federal workers and veterans without fear of lawsuit because in fact they have a liability exemption but that's not true of the broader market so as we talk about the requirements we have in the chairman's talking about protest against these vaccines we must bear in mind that there will always be two schools those who will rightfully so sue us or threaten us if we don't respond and we don't prepare and we don't have a vaccine and those who will respond and protest and if we do as  i hope that this committee will in fact dedicated self as the premier oversight committee of the congress to do this on an annual basis because as much as people may say well we've heard about it before the flu of next year it's not the flu of this year demick of this year may pale in comparison to the pandemic of next year and as we as a congress support the efforts of various organizations both public and private to implement a national strategy to make us as storm since april of two thousand and nine united states secretary of health and human services kathleen sebelius we need to declaration that a public health emergency exists nationwide in involving this virus as the government prepares for the two thousand and nine flu season we must take every measure to ensure that all americans but especially populations of concern including children and the elderly are well prepared for the increased spread of h one n one at least forty six u s children under the age of eighteen have died from the h one n one flying swine flu infection since april h one n one is flu is a new virus so people may have little or no immunity which means that the virus may spread more easily from person to person in my state of maryland we are want a widespread activity alert meaning that outbreaks of the flu or flu like illnesses have been reported in at least half of the regions in the state  is recent evidence of lab confirmed in one in the affected regions in fact h one n one is now the predominant strain of flu in the state of maryland karen lee mellon has sent eight deaths and over one hundred seventy due to h one n one so i'm curious to learn from our witnesses how the administration will address the areas that have been hit the hardest and we have two hundred and thirty five days left in the flu season and vaccinations are expected to be available within a few weeks education around the importance of the seasonal flu vaccine has helped millions of americans see the importance and value in receiving this treatment however with something as common as as a flu shot people are still resistant people are afraid of potential side effects they are concerned that they will actually get the flu from the inoculation and there are those who just do not believe that flu shot will be effective last year in iran interest based survey of some four thousand u s residents results show that forty six percent of adults for whom flu vaccination is strongly recommended meaning those with underlying conditions those over fifty those in close contact with chairman the elderly had no intention of getting the vaccine similarly those especially vulnerable to flu are not getting the vaccine either and that study it was reported that fifty two percent of people with asthma had no intention of getting the flu vaccine with the current state of apathy towards the season flu vaccinations i'm worried that there will be the same or even a worse and case of apathy towards h one n one vaccine sensi and as i quote since the initial outbreak earlier this spring the media has put a strong emphasis on h one n one virus and the need for children to get vaccinated however there is some concern about whether all of the hype is really necessary the center for disease control estimates that an average of thirty six thousand people die from seasonal flu each year while the season c d c s own data shows that so far there have been fewer than one thousand  one and one deaths certainly i know that this hearing will shed light on this subject and one thing that we need to keep in mind mr chairman is that it is better that we be cautious and err on the of caution and making sure that our people is protected no matter what their reluctance might be and we have a if we have a safe vaccine which i do believe we have we need to make sure that we do everything in our power power to convince the pub that is important and they take advantage of it and with that machine i thank you and i yield back and i think a gentleman from maryland for his statement and now you have five minutes to the gentleman from ohio this is a senate thank you very much mr chairman i want to welcome our witnesses  this is an opportunity for still another civics lesson through this committee and that is that we have public health officials here who are once again demonstrating the primacy of the government's role in matters of public out that we have here oh yes a government run flu vaccine program why because government has the resources and the ability to want to connect the two because the fact of the matter is with tens of millions of americans without access to primary care if you don't have access to primary care and you to being able to contract an influential so we have to use this opportunity to explore cause and effect here as well because what we have to d influential issue here swine flu is one thing and more generalized type of flu another but we also have to realize that this occurs within the context of a health care system which is in here today we look forward to your testimony as to how we can prepare the american people of for this influenza season but we also have to understand that there are things happening in health care in america which make our constituents even more vulnerable so every manner of flu and and generalized pandemic that can and soon not just this season but any season and to look at the underlying question here thomas are freed good to see a director of the center for disease control and prevention dr frieden has been trained in internal medicine infectious diseases public health and epidemic director of the national institute of allergy and infectious diseases at the national institute of health dr fogey a native r brooklyn new york a virus is the white house and the department of health and human services on medical and public health preparedness against emerging infectious diseases such as pandemic influenza our next witness is dr jessie goodman the food and drug administration acting chief scientist and deputy commissioner for scientific and medical programs previously got the goodman and infectious disease expert was the director of a center for biologics evaluation and research gentlemen it is a longstanding policy that we swear all of our witnesses in its of us stand and raise your right hand dr friedman wow we'll start with you and come right down the line ok and let me just say that we have five minutes when you start the light is green and then as you move forward becomes yellows which is saying that you have one minute to summarize and then after that it becomes red red all over the united states mean stuff ok you may  thank you very much mr chairman member ice and members of the committee in the spring i was a new york city health commissioner and we had hundreds of thousands of cases of h one n one influenza at that time we didn't have as clear an understanding as we do today of the level of illness that causes we had health care settings that had a great deal of difficulty dealing with the large numbers of patients coming in we had intense media interest and tragically we had some people who became very severely ill and some people died so h one n one influenza is something that we have to take extremely seriously and what i'd like to do is update you briefly on the situation and on our response as of today h one n one really never went away from the spring until now it continued to spread over the summer in summer camps and elsewhere and when schools came back into session and kids went to college we saw large numbers of cases influenza is now widespread across the united states and in fact uncharted territory for an influenza season we've had already many millions of cases and we will have many millions of cases more so far there has been no change in the pattern of illness so the level of illness with h one n one is no more severe than seasonal influenza and intensive laboratory studies have shown no change in how deadly the virus is or no and no significant change in the genetic makeup of the virus that's good news because it indicates that so far it doesn't seem that it will become more deadly in the immediate future and so far it seems like the vaccine which dr factor will speak about more be an excellent match against the specific virus that breading now however influenza is probably the most unpredictable of all infectious diseases there are many variables and only time will tell what will happen whether it will become something that becomes more deadly is something that we just don't know when told time comes therefore the role of the c d c much of which made possible because of the support of the congress over several recent years is several fold we currently have more than fifteen hundred staff working on h one n one response the activities include the identification and characterization of the virus identifying a candidate strain monitoring the spread of disease in the u s and globally and responding through communications with the public guidelines for schools businesses health care providers and a vaccination campaign the vaccination campaign is an unprecedented effort it's a public private partnership with substantial amounts of vaccine coming available in the weeks to come production is rolling and our choice was to let it build up in warehouses then send it out for what we decided to do send it out as soon as it becomes available off the production line and its safety and potency has been verified that means that over the next several weeks there will be some vaccine in the system but there will also be some roughness as it gets distributed eventually there will be enough vaccine for all who want to be vaccinated party people who are at higher risk of becoming severely ill pregnant women those with underlying conditions school children can't contacts of people under the age of six the vaccine will be free in public settings and in private settings there will be no cost of the vaccine although some settings will charge and administration there will be up to ninety thousand different providers across the country providing vaccines and the challenges are significant this is a shared responsibility of the federal state and local governments of the health care system of individuals of businesses and of the manufacturers who are partners in this process progress has been possible because of the ongoing investment by congress we're working hard with our partners in h h s under the leadership of secretary sebelius and the u s government generally and state local tribal governments as well as health care providers and we're committed to regular open communications with the public and the congress it's an evolving situation we're committed to staying open and answering your questions thank you thank you very much  mr chairman members of the committee thank you for giving me the opportunity to review a few of the role of the national institutes of health their research endeavor and the preparedness and response to the two thousand and nine h one n one influenza pandemic particularly in the arena of their development and testing of vaccines against this new virus the national institute of allergy and infectious diseases been involved in basic and clinical research related to seasonal influenza to several decades and we have the responsibility for the development of rapid diagnostics for the flu the development and testing of antiviral drugs the understanding of how the of influenza viruses evolve how they mutate how they transmit what immune responses are induced and importantly we're deeply involved the development of the testing of vaccines to prevent both seasonal and pandemic influenza this last effort is a collaborative process among several agencies of the federal government particularly the sister a gin seas represented here in the department of health and human services in partnership with the pharmaceutical companies that actually manufacture the vaccines as schematically shown on the first poster over there on the right the development of an influenza vaccine is a stepwise process starting with the isolation of the virus up to and including the actual development of a new vaccine for distribution in this regard the two thousand and nine h one n one pandemic influenza virus was first isolated by the c d c and made available to a number of parties including us at the end i h for the purposes of studying its characteristics pharmaceutical companies with which we have long standing relationships in the development of influenza vaccines were given what we call seed or reference viruses for the purpose of developing pilot lots for the n i m h to test in clinical trials historically our institute is set up a network of vaccine and treatment evaluation units throughout the country these groups have extensive experience in the conduct of vaccine trials and we called upon again to answer several important questions that would inform how we would use the h one n one vaccines in this country and worldwide the important information gained from these clinical trials involves safety even though we have safety data from decades of experience with seasonal vaccines which are made in the same manner also immunity unicity or simply put does the vaccine elicit a response that would be predictive of protection against this virus for example what is the correct dosage and the number of doses if we require the use of an enhancing substance called an adjutant to amplify the response and spare doses would this be safe and effective also we need to know about the effect of the vaccine in special populations such as the elderly children and pregnant women as shown in the next post to we have several ongoing trials that have already provided extremely valid well information for the implementation of a vaccination program i can report today some good news regarding these clinical trials for example it was unclear at first whether this vaccine would induce a protective response at all and if so would it require an unreasonable dosage and or a number of doses to achieve this effect we now know that a single dose of the standard fifteen micrograms of vaccine in adults in the elderly without the need of an adjutant is not only well tolerated but induces a robust immune response in a high percentage of recipients this is very important finding and has important implications for the supply of vaccine as well as for his effectiveness in protecting our citizens as well as people throughout the world against the pandemic influenza in addition we found that very similar to the seasonal flu vaccine one dose of the two thousand and nine h one n one vaccine induces a robust response in children ten to seventeen years old indicating that they will require only one dose while younger children will likely require two doses which is quite similar to the case with seasonal flu vaccine current studies are ongoing  pregnant women and we hope to have preliminary data within a few weeks in addition we are planning to conduct vaccine trials in individuals who might have particular difficulty with the h one n one virus such as asthmatic six and individuals with h infection in summary the n i m h research effort into development in testing of the two thousand and nine h one n one vaccine is an important part of the collaborative effort among the sister agencies of the department of health and human services and we look forward to continuing this effort as we face the challenges ahead of us this fall and winter thank you very much and i'll be happy to answer questions later thank you very much  of some of these activities undertaken in conjunction with the assistant secretary for preparedness and response and the biomedical advanced research and development authority under that office have included having  seasonal influenza make no mistake we've worked very hard to get vaccine available as quickly as corners have been cut in this process each facility is expected annually for compliance with good manufacturing practices process controls and product testing or require multiple stages of manufacturing and each must be reviewed and tested by the manufacturer and results in samples of every product even those associated with such a long and excellent record important to realize that every day some previously healthy people will have serious and unexpected medical advance regardless of whether or not are going to get a product in a short period of time we're going to see many people who by chance alone may experience serious events which coincide with the time period it will be challenging but very important to keep we need to take the opportunity to promote the development of new anti viral rapid diagnostics and enhance safety surveillance and a variety of public health all of this will better prepare us for responding to the future threats that we know will also occur so in conclusion we're fully committed and engaged in protecting public health during this very challenging time working together with our partners we've made important progress in providing vaccines influenza is what we have spreading widely in the us today and so that's what is the dominant strain but the bottom line is that anyone who has a mild illness should know that for most people neither testing or treatment will be indicated if however you're severely ill you have difficulty breathing or if you have an underlying conditions such as diabetes or heart disease or lung disease children with certain neuro muscular problems  make it harder for them to breathe or women who are pregnant then it would be quite important if you have fever flu like symptoms to get to see your doctor and get treated promptly because that can make a big difference and over the coming weeks vaccine will become available and it is recommended that people get vaccinated seasonal flu kills approximately thirty six thousand people each year in our estimate although pandemic influenza or h one n one influenza is not affecting the same age groups it's making many millions of people sick vaccine is our best tool and until vaccine is available and even afterwards there are some simple things that people can do to protect themselves their families and their community stay home if you're sick doesn't do yourself or others around you a favor to go out if you've got a fever coughing and can make others sick as well cover your cough when your cover your mouth when you cough or sneeze and wash your hands frequently these three simple steps can make a big difference in how rapidly and widely flu spreads in a community up till now we see that h one n one is spreading more widely than seasonal flu generally does and in somewhat different age groups more young people affected fewer older people affected and the level of severity is no more than seasonal flu but we also don't see it as being less than seasonal flu fati yes i just to reiterate we should take all influenza seriously both seasonal flu as well as the situation with facing now with h one n one pandemic influenza as dr frieden mentioned the burden of disease in seasonal flu is thirty six thousand people each year die and ninety two percent of them are elderly individuals in the majority of those when i say elderly i mean older than sixty five in the majority of them are eighty and older so that that is a an important burden of disease in that age group the difference as you've heard from from all of us with regard to h one n one although it doesn't appear to be any more severe in general in the big picture than a seasonal flu that has a propensity to infect younger individuals in greater quantities and a certain percentage of them unfortunately would go on a very small percentage but nonetheless any death in a young person is a tragedy and under these circumstances we're trying to avoid people getting infected by vaccination and the you know they target groups include pregnant women and younger individuals who are more vulnerable to what we call the complications of influenza and that's the reason why we want to stress the importance of people within those priority groups of getting vaccinated so us should be worried and concerned i would say that we should pay attention to it and follow the guidelines of the centers for disease control and prevention this is dr goodman this vaccine how can we be assured of its safety and if it's effectiveness well the good news is we were able to get married that are completely made in the identical wherry in the same licensed f b i overseas manufacturing facilities with all the same in the people who have been getting it's an immune response that typically correlates with protection against the virus and protection against some of the serious complications like ending up in a hospital or worse the other reason is that as but the idea that health care professionals first responders and how hospital personnel would be required to mandatorily receive the shot can somebody make the case for that because there seems to be very specific pushback from that industry people who find the odds versus the side effects on acceptable the first thing i can make clear is that there is no federal mandate for any individual to get vaccinated ok so the washington post mandatory flu shots hit resistance is is premature there is no federal mandate least one jurisdiction has mandated that unless there is a religious exemption or a medical exemption such allergy to health care workers the vaccines all of you are at this level can you make a case for why the state  compelling interest for that one state versus the other in other words if the state is right then why aren't we doing it from this day and if the state is wrong then are these people being adversely forced to do something that is probably outside the need of government this is something that has been debated for some time even before pandemic influenza came along this time around and in fact the mandate that the state of new york implemented was prior to the emergence of h one n one influenza an unrelated to it the argument is a simple one and an important one the evidence is clear that many patients become ill because they get infected with influenza from health care workers furthermore health care workers are themselves at risk of contracting influenza at their workplaces and of bringing it home to their families there are other vaccinations such as measles which are required of healthcare workers and other annual programs such as testing for tuberculosis infection which are required of health care workers our sense is that this particular season in the midst of a pandemic is not the time at the federal level where we would start a new mandate along those lines but the important point to make is we really we want health care workers to get vaccinated for their own protection the protection of their families and protection so to do the cliff notes in line short five minutes you're not prepared to support at this time but you're not ruling out supporting it at a national level not this year ok and i'm going to leave all of you a copy of h r four thousand nine hundred seventy eight which is from the gentleman from new york mr henchy and i just would like you to follow up it's a bill that would make the armed forces and ultimately all government the goal is to make all government entities liable for litigation for their actions in other words open up to malpractise suits and the like and i'd like you to respond on specifically relative to your agencies which enjoy liability limitation as government entities over and above all other narrow ones how it would impact your agencies if you were fully able to be sued by the public by class action lawsuits for any and all things which you decide to do and i'm doing this for a reason it at a time of first of all because i'm on the day as it's my five minutes but secondly because at the time in which we're talking about health care mr kusin it's talking so baldly about you're a public option there's a number of piece of litigation or legislation coming through that would open up the government option to litigation and i'd like each of you to give me your view of how you're able to do your job without having to worry about excessively the fact that you might be sued for anything that goes wrong and if you could respond in writing  realize that's far more than you might be able to do last question is the h one n one vaccine is for a different group then the flu virus as a whole backs a nation as a whole could you give us your breakdown of in an ideal world if you only had ten million or twelve million or fifteen million doses who should get it first and i say this because we're dealing with seniors versus nine seniors children who it's been reported have actually have a lower inciden problem and this unusual bulge called middle america healthy young people who seem to be at the highest risk and and how that plays for our consideration of dollars and the public message we're confident that eventually there will be enough vaccine for everyone to receive it who wants to receive it in terms of h one n one influenza each year for seasonal flu we've actually about one hundred million people there's also going to be enough seasonal flu vaccine around and anyone who wants seasonal flu vaccine can receive it really for the h one n one vaccine there are five key priority groups this doesn't mean that we deny it to other people but we prioritize these groups pregnant women people with underlying conditions health care workers people who are contacts of people of infants under the age of six who cannot themselves under the age of six months who cannot themselves be vaccinated and then children and young adults ages six months to twenty four years ok think others may want to respond but i do want to thank you and mention that in this case since there's a controversy i intend on getting one of the shots if for no other reason than to show that i believe that it's safe and effective if anyone else must respond thank you chairman thank about the elderly we have in my district probably one hundred senior houses with at least four or five hundred elderly and i'm just wondering they are locked into a situation you know they don't have isolation and things of that nature i was with two groups about early people yesterday and they expressed some concern about the vaccine and i'm just wondering how do you what is your advice to that population and you've got some people who like one gentleman said he said i'm stuck in my ways and i'm not sticking a needle in my and i mean that's what he said and so i'm just how do you deal with that population well what we try to do is to explain to them in a way that's clear that they could understand the risk at their age of getting let's talk with seasonal influenza first seasonal influenza is available right now and since the elderly all the ones that suffer most from serious complications i mention the while ago just a moment ago thirty six thousand deaths each year the ninety two percent of which are an individual sixty five years of age or older i would encourage them to get this vaccine as soon as they can even though they may have skepticism about vaccine whenever you make a decision about an intervention versus what it might do for you you do what's called a risk benefit analysis and i think if you look at the risk of a vaccine that has decades of a good track record for safety and the risk of an elderly individual who gets influenza coming up with serious complications which might trigger a very difficult clinical course for them in my mind and in the mind of people who do this every day it's overwhelmingly weight towards getting vaccinated if you're an elderly individual if you're thinking about h one n one is dr frieden just mentioned there are five target groups of those target groups since the elderly individuals greater than sixty five if you look at what's happened over the spring and in the summer and in the southern hemisphere over the year the individuals who are in that elderly group do not appear to be particularly susceptible to the h one n one that doesn't mean that they shouldn't get it we just would like to get the people who are in the five target groups vaccinated first and then virtually anyone can get vaccine as we all mentioned we feel confident that we will have enough vaccine at the end of the day for everyone yesterday  only other population i spent five hours with was the hiv population as you know being from maryland that fifty percent of all the hiv cases are in baltimore and ninety percent of them are african american  and you talked about trials still being conducted and i know that you're not you don't have a magic ball but do you predict that they're going to mean that it will be safe for people with  a compromise group even without clinical trials i would like to see them get vaccinated as part of the group that's particularly susceptible to getting complications of it and piggyback on some comments of mr percentage people of course with with no insurance we've got folks under insured we've got people who don't have as much access is as others do to sufficient health care is this a concern of yours is there a certain point where you see can see as getting so overloaded with regard to these cases and seems like it takes you get to a certain point with this is a and it seems like it takes some intensive medical care and i was just wondering where are we on that and what do you predict and if such should take place what plans do you have ready to go into operation i don't want us to have another katrina type situation where we say that we're ready for something and then when the time comes there is at least a way forever to meet the road and then we discover there is no rote it will be there will be challenges for sure particularly when you have widespread outbreaks in various regions of the country as we're seeing even right now in certain regions of the country but you want to i think that the reality is that our health care system doesn't currently have a good information system that w allow us for example callback everyone who needs to be vaccinated it doesn't have good coordination that would allow us to share information and share resources within areas in most parts of the country and it doesn't emphasize prevention so we have vaccination practices that aren't as good as we would like in some groups of doctors for example obstetricians as we try to get pregnant women vaccinated so i think the challenges that we face and how can i think everyone can and i identify many of those are going to be played out in this also the response is going to be a state specific response so states that are better prepared to operate a vaccination program which have more resources for surge will be better prepared to deal with it the health and human services with support of the congress has provided more than three billion dollars in hospital preparedness over the past seven years for additional ventilators for exercises for surgeon planning and preparations and i think we much better off for those preparations that have occurred so far but the challenges are real the virus is potentially spreading rapidly we do want to encourage p who are not don't have underlying conditions to try to improve the surge capacity of america's hospitals but so many americans hospitals right now are locked into a system where they're actually rewarded for turning people out of a hospital bed or as if people are hit with  they're quite likely require extensive hospitalization i just want to go back to the point that i made which i appreciate my colleague mr cummings reiterating and that we cannot forget the broader context of health care in america  to protect those who are most vulnerable such as the elderly mr cummings was mentioning now i'm hearing from our one of our staffers who is a physician dr lopez in our cleveland office says that in cleveland chain pharmacies will have an ample supply of the flu vaccine while doctors are still waiting for shipment they would want to give to their patients if you heard about anything like this and is this a nationwide  problem in terms of the seasonal flu vaccine there will be something on the order of one hundred fourteen million doses available this year they've already been more than fifty million doses distributed throughout the country and while there may be some focal areas with shortages there's going to be plenty of seasonal flu vaccine for anyone who wants it the seasonal flu vaccination program is ninety percent through the private and voluntary sector and not through the government sector h one n one response will be ordered a little differently to try to ensure that there is access and efficiency to the system around in the seasonal flu vaccine whoever orders first gets first and so  happens it has to do with when it's ordered so the earlier in the season that provider or pharmacy orders earlier they're likely to get it as we have the h one n one system we're not using that system we're using a different system which will give the state health department or state government authority to authorize to where within the state it would go and provide equity across the state in the country in terms of a valid as well as try to get it out to places that don't usually services do not have authority to control influenza vaccine distribution nor the resources to manage such an effort that's a quote can you please clarify who in the private sector controls who gets the vaccines first the c d c provides guidance and some resources for planning ultimately it's a decision of each doctor each medical provider patient of whether or not to order the vaccine and whether or not to give it or receive it who in the private sector controls  moment as well because i just saw television advertisements and we don't want government to run health care what would happen you know if this particular flu spread across as it is doing now and the government wasn't there we are indeed the safety net let me get into what i was apparent to say as a result of the nation's economic conditions and in doing budget crisis my state the state of california has had to make millions of dollars in cuts to our state and our local health departments and programs  is there in the fear that the economic crisis that states such as california and there are others too are facing will have an effect on pandemic preparedness are their ability to effectively and efficiently distribute the one n one vaccine and thank you so much experts for using h one n one and we're trying to teach our constituents that it is not the swine flu so thank you for reinforcing h one n one can you respond yes we are quite concerned about the state of the state and local public health departments we've seen decades of under investment in public health in the public health infrastructure that has been exacerbated over the past couple of years with the economic crisis so we are seeing layoffs attrition furloughs freezes in terms of hiring this makes it even more challenging to implement the vaccination and overall response program we have provided now are in the process of provide now nearly one point five billion dollars to state and local governments for preparation planning and vaccine administration for providing the vaccine free of charge along with the needles and alcohol disposal equipment that would be needed with it we're providing technical assistance and guidance and i think we will inevitably see some variability in the different states with some better prepared and others less well prepared the c d c has staff on the ground in the field in virtually every state in the country and we provide whatever whatever assistance we can but again it is a shared responsibility in the state government state government does have responsibilities as do the local governments as there is the federal government my concern is that  being the largest state in the union and california being the first state that is a majority of minorities and most of our immigrants come across the pacific and not always over our southern border and people are coming in are already infected are not having one day health care and so it hits our state with a greater wallop than a lot of others because of the demographics during the initial h one n one outbreak in the spring it's important to note that there are probably a lot of people who actually contact with the h one n one virus but never got it specifically diagnosed and that relates to right what i just told you about the demographics believing it to be the seasonal flu virus and do those people who have unknowingly had the h one n one flu have the potential in the extra risk are complications when getting vests and even for most people with average fl there is no reason to be tested or treated so the fact that they weren't is not going to harm them however anyone who is severely ill over who has underlying conditions should be promptly attended to to reduce the risk of severe illness so most people who had the flu in the spring won't know whether it was h one n one or not we recommend that they all get vaccinated and there is no reason to suspect that the vaccine would be risky or riskier for people who have had the infection before about you know i actually not at all i agree completely with dr frieden if you have gotten h one n one in for example in the spring in school will say and then we come back now when you want to vaccinate a child first of all the vast majority of times you won't definitively know that you had h one n one though you could assume it if it was rampant in the community but there's no evidence scientifically at all that suggest if you  vaccinated with a vaccine against h one n one that you are at any greater risk for any toxicity or any adverse event thank you very much thank you very much and now you minister the gentleman from virginia the kindly influenza strain that struck in kansas was mild not severe eerily similar to the way you described this strain and involved in this valley and in the town of hit no fatalities is that not correct lethal was it it jumped into mustering camps it just so happened the united states was now mustering large groups concentrating groups in overcrowded conditions of young men who were being trained to go to the trenches in france in world war one and when the influenza strain went from that kansas town to the nearby military camp it transmuted into something far more lethal that led to many deaths and then spread around the country is that true there is a lot of different theories about what happened in one thousand nine hundred nineteen it's clear that crowded conditions such as barracks are breeding grounds for influenza as well as other infectious diseases there are some theories that it was actually demobilizing individuals coming back to the us that may have brought the flu why there was apparently a mild spring wave followed by a severe four wave is as far as i know not definitively known and perhaps dr pao if you would like to comment for our it really is all theory and hypothesis of note which people don't fully appreciate is that the virus that was in that early spring wave as they call it that virus has never been isolated or identified the virus that hit like a vengeance in the late summer and fall of one nine hundred eighteen that virus has been dug up  sequenced and we know what that virus is we have no idea what the relationship between that virus is in the virus from the spring because we've never had any isolates that had been molecular analyzed so it really is just a big theory that we today could have been actually two different strains absolutely could have been ok now you touched on the fact that you've got sort of five targeted groups in terms of vaccination for h one n one and i was heartened to hear you say that the included in there that actually it seems to affect the over sixty five population a less severe laced on some others that was a characteristic of the pandemic of one thousand nine hundred s well was it not but actually the most effective group in terms of sever was actually the sort of fifteen to thirty five with where when young people's immune system was at the peak performance but it kind of went on the hyper drive and over reacted to the introduction of us and a lot of young people turned out to be more vulnerable and it's the it's a very interesting question there are two aspects to what you said if you have a sixty five or seventy year old person who is less susceptible to getting infected in the first place it is likely that that person during the experience in the alive decades and decades before came into contact with a virus that had some degree of similarity which provided for them a background type of immune response so that they were able to avoid infection with that particular virus in fact this may be exactly what's going on right now with elderly individuals who seem less prone to get infected with h one n one because of prior experiences that they have had during their years either of previous exposures to viruses or even previous vaccinations that they may have had that's one issue the other issue which dates back to the response to the virus in a vigorous healthy young person allows for a greater damage to the lung tissue and an outpouring of inflammatory cells so there are two issues going on this prior exposure and the strength of your immune research and certainly there the accounts from nine hundred eighteen are legion of precisely the knowledge that young people healthy in the morning and dead by night but let me just ask a final question but this has implications for if you will try and the distribution of vaccine should it be in the short supply two years ago for example we had a scarcity of flu vaccine you will recall and automatically the protocol was all right whatever supply we've got is targeted for the most vulnerable people over sixty five and very young in this particular case that would be the wrong model would it not right and that that's exactly what we're most concerned about and exactly what we're doing which is to prioritize to the groups that would be at highest risk of severe illness and also to monitor very intensively so every day samples are sent to c d c and we analyze the data to see whether we've seen any change in the level of severity or in the genetic pattern of the virus that would suggest that it could become more deadly and the good news is that up till now we have not seen any significant change in the pattern of the virus nor in the pattern of illness and people i thank the chair they very much and now you have five minutes to the gentleman from maryland  very different than the kind of flus that we've been used to addressing with respect to the five hundred ninety three deaths so far from this h one n one is purses up the number that you have is that correct five hundred ninety three deaths in united the sixty five plus age range with a lot of those being in that eighty plus with respect to the deaths so far from h one n one what would what we've seen is very few deaths and people over the age of sixty five there have been about fifty plus deaths in children under the age of eighteen and then the bulk have been in that that young to middle age group about two thirds to seventy percent have been among individuals who have underlying medical conditions such as diabetes or lung disease asthma or other problems and the level of the hospitalizations have followed a similar pattern although slightly different in terms of people with asthma may be hospitalized more but less likely to die people with diabetes or underlying conditions more likely to unfortunately tragically die so i mean based on those the years it sounds like almost the reverse of the normal seasonal flu in terms of age impact it's the reverse of most seasons with different there are different types of flu and this the h one that particular type of flu characteristically does affect younger people more than older people even if it's not the strain right now if that one of the reasons elderly people aren't as severely impact is because they've had earlier seasonal flus or they've had earlier  scenes that may have helped them it does suggest that this strain is very different than the strains we've been seeing for a very long period of time because otherwise i sin they would that's why they that's why young people are feeling it and they're it is very different but there is some strong suggestion that individuals who are elderly have i have of the percentages highest thirty thirty five percent of them have antibodies that actually would cross react with this flu even though we've never seen in our history anything like this in the sense of an identical virus like this there have been other h one n one has there been people have gotten vaccinated against the swine flu in one thousand nine hundred seventy six there are people who have gotten exposed to h one n one years and years ago it is highly likely that those individuals do have some degree of sub liminal background immunity that when they see this virus they mount a reasonably good immune response where is the young youngsters children adolescents people in their twenty's but that doesn't seem to be the case it spreads very widely through them right just in terms of the rate of transmission right now be how does it compare to the seasonal flu there's been there's a fair amount of data some of it conflicting about that what we do know is that we don't see the kind of explosive outbreaks in schools and colleges in most flu seasons that we're seeing now in new york city we had one school that had over a thousand kids who had h one n one and we just don't see that so certainly in some populations the younger adults and children it seems to spread quite readily sometimes but the overall rate of spread is is not entirely clear just following up on that and getting to the question of the adequacy of our state and local public health response i hope that although this is a distribution happens at the local and state level with the support that you're providing the federal level i hope that you can monitor very closely the local impacts and in some ways hold people accountable as you said there's going to be some variability but it seems to me we have a responsibility the federal level to make it clear where we do not think that the local response is  adequate and i hope that all of you will agree that that is a responsibility the federal government i mean sometimes not easy going have to be calling out shortcomings in terms of the local response but in the interest of public health it seems to me we should have some kind of grading system or some kind of way to identify who is responding adequately who's not which is especially with respect to schools where you've got a lot of young people obviously gathered and this is a of the flu that has a very severe impact potentially you know we have certainly do everything we can to support states and localities to respond effectively and provide whatever supports possible i think there will be attention to the areas that are not vaccinati numbers or where vaccine is more difficult to to obtain there are going to be real challenges particularly in the next few weeks at the vaccine program just beginning to roll out including to places that don't usually vaccinate such as schools  gentlemen time is expired we have the second round thank all of the witnesses you know that vaccinations often bring a fear to many groups and the ability to spread false information is always prevalent one of them ation have you come across regarding this flu strain or this vaccine that you believe is false so confusing do you i think that these are things that you know i'd like for you to clear up this is an opportunity for you to do so because we want to make certain that accurate information is getting out there and being we have the experts here we want to make certain that people know exactly what's going on and the other thing that people are saying which in i find this one very interesting that if you want to avoid it don't live in the south go to a cold area and that you don't have to worry about it so i guess he went to niagara falls i guess it would not be a problem you know call in to what information that's being passed on out there by people so i would like for you to take this opportunity to clear up this so people will know exactly what we're dealing with here because as you know some people when it comes to vaccinations anything of that sort a just don't want to participate so right down the line  i'll start and then my colleagues i'm sure will add to it first in terms of the spread it's it's very different in different parts of the country and it will change from time to time currently it is more prominent in some states than others but it's widespread across the u s there's more in the south of the u s possibly because schools went back into session sooner there are at least three common myths about flu which are important to confront first you cannot get the flu from a flu shot not possible it's killed the vaccine and there's no way you can get the flu from it you can get a sore arm but you can't get the flu from a flu shot and that is perhaps one of the more common misconceptions the second which is common and problematic is that flu is not necessarily a mild illness it's not the common cold that can knock you flat on your back and make you quite sick for a while you can miss school work and if you're unfortunate or have an underlying condition it can put you in the hospital or even kill you so flu needs to be taken seriously you can't get the flu from a flu shot and the flu shot is highly protective against what is what can be and is for many people a moderate illness that is unpleasant and third in the public settings for the h one n one vaccination program which will start in a few weeks the public settings immunization clinics schools vaccine administration and the vaccine itself will be free to the person being vaccinated they may build your insurance company or medicaid but no one will have to pay for it out of pocket in the public sector vaccine clinics it may be that the private sector sometimes has co payments and we've encouraged them to waive those for h one  n one vaccination and many insurers have agreed to do that but at least for the public sector it'll be free and the vaccine itself will be free everywhere there may be some administration fees in the private sector just to add in the another one to  dr frieden is that we've heard and i'm sure you have mr chairman about some people who feel maybe it's a good idea to actually deliberately expose yourself to get infected you heard about flu parties people getting people together like you have these chicken pox parties that's really a bad idea it's a bad idea because as dr frieden said influenza can be a very bad disease even at its best sometimes it makes you very uncomfortable and puts you out of sorts if not out of school and out of work and also even though there's a very small percentage of people who go on to real serious complications you can't predict too that's going to be so the idea about getting infected deliberately is a real bad idea with a real good idea is to get vaccinated i think one very important myth here is that somehow that seems in general and in particular this vaccine may be unsafe for pregnant women and i think it's very important to realize that pregnant women have been among the groups most over represented in having serious outcomes for themselves and their  offspring with this flu and these vaccines although there aren't a lot of formal studies in pregnant women have been safely used every year and hundreds of thousands of pregnant women and studies that have been performed about their use have not shown any increases in adverse outcomes for the moms are there so there's not a known risk to pregnant women we certainly continue to collect more data there is certainly  to pregnant women and their babies from getting this flu very quickly because the time it expired i know that it's not a federal policy but as you know some states are requiring that the public health workers that they receive vaccination and ask are you monitoring this because i think that is something that really needs to look be looked  workers who provide their care don't get vaccinated and perhaps the experience from the jurisdictions that are doing this will be helpful in trying to understand that further  take any and all substances that are not grown in the ground cut off and freshly cleaned how is it when when i hear the list of who should get it first that isn't first why isn't that the group that most of you need to make sure are first heard as the because they have a reluctance even if they're only among the top shouldn't they be the first that you say pregnant women or those who expect to be may become pregnant should not be the first group with their high immune and their particular n h one n one their their likelihood to fight more aggressively the disease we don't distinguish among those five priority groups all of them are equally high priority and for each of them we have it's like it's like going to school in a through f being equal but i notice a subtle difference between a ninety one and a fifty nine but it made all the difference in the world when i was going to school for each of them it's important that we reach out so we work with the american college of obstetrics and gynecology to help get vaccine out and promote vaccination for pregnant women we're working with magazines mothers magazines net resources and others for each of those groups i think there's a special effort there is a special effort to try to reach out to the most appropriately the bulk of the people who have severe illness and death from h one n one are not pregnant women but pregnant women are at six or eight fold increase risk of severe severe and negative outcomes and so we do want to really prioritize vaccination in this and other groups although we do understand that there is reluctance and will be the size that it would be logistically really a problem to have a first year second year third because if you have distribution centers that are actually giving vaccines and someone is among that was five target groups that we will mention during this testimony that if a pregnant woman walks in and says i want to give x and she will get vaccinated because not only is she among the five target groups she's even among the five priority groups within the top get and within they that is there is a difference in me do one follow up question since the former chairman of this committee isn't here today and since he has been an outspoken critic of the side effects real and or alleged of heavy metals in vaccines can you discuss the level of you know the right term for the care small amount of metal that's sort of part of the carrier in many vaccines as to both today's flu vaccines yes some no so a patient can say i only want metally or thimerosal used as a preservative in multi dose vials in single those files it's not necessary by and large there have been a series of scientific studies that have not linked thimerosal with autism autism is a very serious problem and it's a tragic problem for the parents who have to deal with it often but we need to continue to make efforts to identify th causes and ways of preventing it there is good data that suggests or indicates that there is no link between vaccine and autism however because we want to accommodate the concerns of people who believe there may be and we want as many people to get vaccinated as possible we've i'm aerosol free vaccine available to the extent possible since you have to have a preservative in a multi those vial it's not possible to eliminate it completely so those those who choice but given that there is no known risk and the scientific community including the institute of medicine in two thousand and four found there was no connection between my marrow saw in autism that it would people should consider carefully the idea of not getting vaccinated because of this concern and in closing doctors i asked the question one because one member of not here at the day as is terribly supportive of the theory that there is still a connection  and i don't want to say that he's wrong because i'm not qualified but i think for everyone that will look at this hearing being aware that if you have a young child or pregnant woman who has that concern that there is a way to get us past that concern and understand that if you're a member of congress you get hit every day or every month by somebody who wants the fluorine out of the water to that that in fact there is an interest group against almost anything you can name and if it spreads into a portion of society that would not protect themselves and i think that's where we have the interest for the question i appreciate your understanding and i thank you mr chairman for giving us this opportunity to go back to gentleman from maryland  quiet a high risk for complications h one n one infection because of chronic disorders that compromised immune system you know you c span here watch you tell us exactly what those diseases are because one of the reason why i'm saying that is we've got twenty six point six million people in the united states with diabetes who probably unless a doctor tells them that they are high risk they may not know it we've got people who are on chemo with cancer and of course chemo you are going to doctors are never spent one day in medical school but i do know that chemo can compromise demian system is that right of course we've already talked about h i want you all the tell the american people see if i've got eight percent of the population that has diabetes and don't even know that they're at high risk i want to make sure that these the other folks using this wonderful opportunity we have here we need to let them know that they are at high ris right now could you tell us what those diseases are that we're most concerned about anyone who as you say has diabetes anyone who has a chronic heart condition such as congestive heart failure anyone with a chronic lung condition that would make it harder for them to breeze such as emphysema or asthma anyone who has immune compromised such as being cancer chemotherapy or someone with hiv and even with a neuro muscular disorder someone who has trouble breathing on their own miocene a gravest or other albums that cause a weakening of the musculature people with underlying health conditions which give them less reserve to call upon if they become infected with influenza are more likely to end up in the hospital and more likely to die and that's why these groups are so important to be vaccinated when vaccine becomes available and if someone in one of these groups becomes sick with fever with cough so important that they get created promptly ideally within forty eight hours and how we get in that word out always telling doctors and i mean i'm telling you i'm sure there are people watching this right now  women diabetes that you know and the reason why i'm so concerned about that is because there's so much diabetes in my district and i'm sure a lot of districts and i you know when you say you know somebody who's in that time category when you said diabetes automatically jumps out at me but god well we are trying and and we appreciate the opportunity to say what dr frieden just said at a hearing like this that is on c span that's one way of getting it out virtually every day we talk about this the c d c has and i could say that because i'm not from the c d c as a beautiful web site that you click on and they just list them all and we keep talking about it from secretary sebelius is self down to the people who are doing the clinical trials in the trenches so this is something we constantly talk about by agree with you we have to keep shouting it from the hill so people understand that because a lot of people who are in the risk categories don't really fully appreciate that they are and i think you mentioned one of the most important ones of diabetics they're probably you know if diabetics eight percent and then we put in all of those other people to do all just mentioned we may be talking about twenty five percent of the population is that that unreasonable figure is it that that's just in the vaccines but you are testing them as well we include adjured dancin in our seasonal flu shots is that right no we don't know ok and there's a rumor that we will run out of th vaccine is seen as soon as we produce is that's not true even that's not right rumor that's a rumor is not correct ok we fully expect that we will have enough vaccine of the h one n one two thousand and nine for all who want or need and we certainly will have enough of the seasonal influenza vaccine based on the history of uptake of seasonal flu vaccine so we feel confident that we will have enough for everyone who wants and needs it without the use of adjutants i go back to what i said a little bit earlier  i i do believe that sometimes is not your office i'll be very brief misjudgments that we operate in sadly in a culture of mediocrity in our country and i will never get katrina as well as i live and i just want to make sure that going back to my friend and colleague from alan what mr van hollen said i just want to make sure that we hold our entire all of our agencies accountable and i know that may be difficult to do but i agree with them we cannot have another situation where we think we've got on with everything under control and we don't thank you very much mr chairman so much let me just whatever who has i think we need to put on the record and let people hear it ok i go to the c d c website every day and they are found of information and i would recommend that if anyone wants to know anything about the kinds of things we're talking about right now it's an it's very very easy it's blue dot gov f l u dot g o v just click on that and it's there you could just search anything you want that has to do with flu all the things we're talking about risk categories vaccines etc because i mean that's simple we're trying to make certain that people have accurate information you know and that's what this is all about i want to thank you the witnesses again for being here today and of course we want to get this information out i would also like to thank you for the work that you are doing on this issue as well and i'm certain that the american people would take you would