shirley in his book citizen new to, the making of a reagan conservative. author sasha talks about immigration with his book go back to where you came from the backlash against immigration and the fate of western democracy. watch our live coverage of the tenth annual tucson festival of books on c-span2's book tv. >> today, government officials testified about preparing and responding to seasonal flu before a house energy subcommittee. they addressed the effectiveness of vaccines and finding the best ways to dispel myths of vaccinations. >> good morning. this year, like so many previous years, we have had a bad flu season. after months of record-breaking widespread flu activities the cdc has reported that the flu season is finally peaked. we are finally still going to see flu activity until the

middle of april so if you have the flu or flu symptoms it certainly is important to see your doctor and stay at home. influenza is the leading cause of death in the united states especially in a severe flu season. every year thousands of americans die from the flu and thousands more are hospitalized from flu related combinations. 2010 the flu has caused between 12,056,000 deaths a year and this year was no exception. tragically as of february the 24th there have been already 114 influenza is associated pediatric deaths the season. some of those deaths occurred in my home state of mississippi and although we have enhanced our preparedness for the flu in recent years there is still room for improvement. the best way to get the flu is by getting your flu shot. millions of americans receive a flu shot every year to help

protect them against the stillness unfortunately there are many americans who do not do that. last year only 59% of children and about 42% of adults received flu vaccinations. even though only a little over half of americans to play get vaccinated cdc estimates that flu vaccination prevented 3000 pneumonia and influential desk during the 2015, 2016 flu season alone increasing the number of flu vaccine will prevent more deaths and illnesses. the only will the flu vaccine help prevent an individual from getting the flu but also help reduce severe outcomes when someone does get sick the flu. during the past seasons 80% of flu associated deaths in children have occurred in children who are not vaccinated. similarly a recent study found that receiving the flu vaccine produced severe outcomes in hospitalized patients by producing deaths, producing icu admissions, reducing length of stays and reducing overall

length of stay for hospital patients. while the flu vaccine is currently the best tool to prevent illness there is room for improvement in the cdc recently announced the shares flu vaccine was only about 36% effective in preventing an individual from getting the flu. the vaccines effectiveness varied from different age groups and for different strains of the virus. example, the vaccine was 59% effective in children however it was much less effective in adults. for all age groups the vaccine was only 25% affected seasoning is the deadliest strain of the flu, age three. it reduce the effectiveness the most violent and prominent strain of flu the season and it is especially concerning. historically we have struggled to make an effective vaccine against age three and two and

for example, during the 2014, 2015 flu season this committee closely examine the flu vaccines reduced effectiveness do the mismatch between the 83 and two strain is to develop the vaccine and the age three and two strain that was circulating during the 2014, 2015 season the flu vaccine was only 9% effective had mutated before the flu season began. this experience reminding us of the importance of being able to rapidly detect and respond to changes in the challenging circulating flu viruses. according to the fda this year the vaccines reduced effectiveness against the age three and two virus was not caused by mismatch. one factor that may explain while the flu vaccine was not that effective is a mutation caused by the vaccine and adaptation through the manufacturing process. currently about 80-85% of the

flu vaccines are manufactured through the egg -based manufacturing process. with and affected is blue back in chicken aids during the manufacturing process genetic changes can occur in the virus to make the vaccine less effective in humans. some researchers think that egg capitation might be especially problematic for the age three and two virus and of course there are many different factors that also might explain the flu vaccine for age three and two. this issue needs to be thoroughly investigated so we can improve the vaccine manufacturing process if necessary and improve the vaccines effectiveness in the future. i update the hard work and dedication of the people at hhs to prove our flu preparedness including those the, nah, and fda. one of our top priorities is to keep americans healthy during

the flu season and improve public health spots. i look forward to the testimony today. the chair will now recognize ranking member for purposes of an opening statement. >> thank you so much, mr. chairman. i'm happy to have this hearing which seemed to do every year. looking at the witnesses i feel like were getting the band back together again to talk once again about what we can do. i appreciate you all coming in i am hoping that this year we can make progress in talking about all of these issues that the term invention. we have had in this subcommittee seven hearings flu preparedness in 2004 and most recently in 2015 we had to hearings after the country was set with a particularly severe 14 and 15 flu season in which the age three and two dominated in this year again we are experiencing a

severe flu season caused by the age three and two in that is a stark reminder of how the flu is very serious. hospitalizations have been height of the country and 114 children have died. as an example my home state of colorado set to record, not good records this year, with nearly 4000 people hospitalized due to the flu and 160 flu outbreaks in long-term care facilities. as a chairman mentioned this year's flu vaccine was only 36% effectiveness and that is a concern. even i had the flu and i had my vexing, too. this really is something that one would think we would be able to tackle in a more meaningful way. i understand that the fda's flu vaccine or the vaccine advisory committee met to make

recommendations for next year's vaccine and i'm looking forward to hearing from the fda about how data on this year's effectiveness and how it will inform the decision-making for next year. i am also hoping, as usual, to hear more about research efforts to produce a more probably perfected vaccine or even a universal vaccine that can target all stream strains of fl. mr. chairman, we talked in these areas hearings over the years about the egg -based vaccine and the mutation of the virus in the egg is only one of the problems and when you look at the more remote but real threat of a pandemic flu if you are relying on egg -based vaccines you can be very nimble in producing vaccines in an effective and fast-paced. i think that this year if it is

any good news, a silver lining about the ravages of this flu season maybe it will make the public understand how important this issue is for our public health agencies to address. all of our witnesses will remind us even a vaccine with a low effectiveness rate was the perfect millions from getting sick or may help mitigate the symptoms to get sick. until we fix the system in a broader way the flu vaccine is still our best tool but unfortunately the number of americans who got a flu shot this year has not changed from our last hearing in 2015. i'm hoping that is another thing we can discuss about how we can persuade people to get the vaccine in concrete steps that perhaps we could take next year. as i said, we also have to work to get better treatment methods.

in particular, more effective antiviral medications so that people who do become sick can be cared for further illness becomes more serious and i understand there are some of these medications in the pipeline right now. maybe some of our witnesses can talk about these drugs in the pipeline and also maybe they can talk about some of the spot shortages we saw this past season. finally, the importance of a strong public health and the structure cannot be overstated. because of the critical work of federal and state public health experts we are always in a good position but there is still more than needs to be done and i'm looking forward to hearing how we can ordinate our strategies across all levels of government. mr. chairman, again, i want to thank the witnesses and some of which i've worked with for years their true public servants and truly dedicated to tackling this issue and i know they will be

our partners in this committee as we continue to go forward. thank you and i yield back. also, i'd ask unanimous consent to put his opening statement in the record. he will not be able to come to. >> without objection. gentleman with yields back,. >> i think our witnesses for being here today. this is ben i think one of the most first flu season the united states we seen nearly 50000 people died in a single season. today we are currently experiencing a severe flu season with a prominently deadly strain by all accounts. we will find ways to reduce deaths and hospitalizations from this challenging and changing virus and in the subcommittee in particular we have a long history, as you've heard of conducting these oversight hearings and trying to be as helpful as i can to you all as we work on the public policy. during the last hearing in november 2015 we had many

important issues including health department of human services to help improve our ability to respond to seasonal flu vaccine mismatches. more than 70 years flu vaccines have been made during a this process over the last decade we've seen innovation in manufacturing in the annual flu vaccine. the approved the first flu vaccine manufacturing use self culture technology and health in the fda approved [inaudible] in addition to new manufacturing technology and methodology we have also seen in times of flu vaccine made available for the american people. historically, the vaccines are standard and offered to protect against three different strains of flu virus and in 2012 the fda approved the first flu vaccine that offer protection against four different strains. in zero nine their post they approved the first high-dose for older adults and data showed

that the high-dose flu vaccine is more effective in older individuals in the normal dose. now the ways to manufacture the flu vaccine we need to ensure that we have enough data and information that were making the most effective seasonal flu vaccine possible. the fda recently announced its primary data that the it may be more effective in preventing the flu in the egg -based vaccine the season. we need to understand why that might be and why there are differences in effectiveness so we can prove manufacturing processes if necessary. as subcommittee chairman harper has said and emphasized the annual flu vaccine is still the best defense and every year thousands of lives are saved because people get that vaccine. if you do get the flu there are antivirals as we all know and i can't remember a flu season or more people i know said i've got tamiflu or someone said i that tamiflu or whatever the other bibles are so that's an

important part of this, as well. i love you to talk a bit about what has been in the press about the japanese product currently in japan that might cut off the flu even sooner and what we see on that one if anything. one day we hope to have universal vaccines and were encouraged by the national institute of infectious diseases recently released a strategic plan for the universal flu and i'm glad we have all of you here today. no one thank you and that i yield the remainder of my time to the chairman of the health committee, the doctor from texas. >> thank you, mr. chairman. i want to thank our witnesses for taking the time to testify before us today. most of you are well known to this subcommittee. the flu has hit many of the large districts with astonishing forces your in district that i

represent north texas public health apartments restraint we had schools that had to close temporarily to prevent the spread of blue amongst the children. since the start of this flu season more than 400 people in the area have been hospitalized as a result of the flu and help reported associated desk one pediatric. early this year the health subcommittee was briefed by the doctor and someone from cdc about the development and effectiveness of the shares flu vaccine and the timing of this particular hearing is appropriate given that we are just past the peak flu season and now people are working on the development of lectures vaccine and we are all anxious to hear what awaits for next year. mr. chairman, thank you for holding this important and timely hearing and i certainly look forward to hearing from our witnesses and the yield back. >> gentleman yields back. i ask unanimous consent that the members opening statements be

made part of the record and without objection it will be entered into the record. additionally, i ask unanimous consent the energy and commerce members not only on the subcommittee to purchase paid in today's hearing and without objection, so order. i now introduce our witnesses. first today we have the acting director for the centers for disease control and prevention. we welcome you today. second we have the director of the national institute of allergy and infectious diseases at the national institute of health. then we have the deputy assistant for preparedness and response and director of the medical advances research and development authorities in the office of assistant secretary for preparedness and response which means there is no way that gets on a business card. we are glad to have you here. finally, the honorable scott gottlieb serves as a commissioner for the us food and drug administration. i want to thank you each for being here. this is a very important topic and we look forward to having this discussion today.

are you each aware that the committee is holding an investigative hearing and when so doing we have the practices taking testimony under oath but does anyone have an objection to testifying under oath? none, the chair then advises you that under the rules of house and the rules the committee you are entitled to be accompanied by counsel. do any of you desire to be complete by counsel for the purposes of today's hearing? see none, i in that case if you would please rise. raise your right hand i will spare you in. do you swear that the testimony were about to give is the truth, the whole truth and nothing but the truth? you may be seated. you are now under oath and subject to the penalties set forth in title 18, section 1001 of the united states code. you may now each give a five-minute summary of your written statement and we will begin with the doctor and you

are now organized for five minutes. >> good morning, mr. chairman and members of the committee. influenza is a formidable adversary in the virus is ever-changing and with us every year and it is too often able to outsmart our immune system. at cdc we have worked with domestic and global partners to build cutting-edge systems and to characterize influenza viruses in the diseases they cause and to monitor vaccine effectiveness. we know that people are concerned about this flu season and that concern is warranted. influenza can be a very serious threat to the health of americans and despite the progress we have made we have much more work to do. i will provide updates about the season and the work that cdc is doing to improve the tools for influenza prevention in control. as you heard this is been a severe season hospitalizations

have broken records in influenza -like illness presenting to doctor offices in emergency is at his peak was about as high as we saw during the pandemic of 2009. too many children have died already from influence of this season already. we have intense activity in virtually the country at the same time and that contributed to some of the shortages of antiviral. we are not over with the season. disease is decreasing but the b strains are starting to be as common. as you heard the vaccine effectiveness the season was lower than usual. that 36% overall and even lower for the age three and to strain that dominated it. children didn't receive better protection from the flu vaccine. 59% effectiveness in children and about 50% effectiveness against the age three and to

strain. a reminder that vaccinating children can be lifesaving against the flu. the vast majority of children to die from influenza have not received any vaccine at all. there are many theories about why influenza vaccine works less well against the age three and to strain and one theory is that the egg adapt to changes that occur in the process of developing the vaccine and there may be differences in effectiveness in prior immunizations or prior exposure to strain but we're still characterizing the viruses and we do not think there is intergenic thrift but there may be some changes in the viruses that could account for the severe season and that is still under study. some vaccine is better than no vaccine protection and we wish it works better but we do know

the vaccines are providing protection to many and mitigating the severity of the disease. cdc has three objectives in our work with vaccines. we want to maximize you use of the current vaccines and support the nih's leadership in developing universal vaccine and in the near term we want to improve the current vaccines that we have. have made significant progress since the 2009 pandemic and the more data than ever before and more information on vaccine effectiveness for multistate network and we have more potential vaccine candidate and were collecting more information on the genomic characteristics of the viruses using the next generation sequencing and we are working with pharmacists in long-term care facilities and insurers to ensure that the shortages indirect girls attend viral and moving it out of season we know people are so frustrated despite the progress we've made there is still much more to learn on influenza in

that investing in that learning can have direct completions for prevention and control. in closing, i know this has been a typical flu season and a heartbreaking one for too many families. flu continues to be a priority for the cdc and we are literally working 247 on this issue. we are all across hhs committed to working together to find ways and tools to help americans reduce the risk of getting sick and i look forward to answering your question. >> thank you very much. the chair will now recognize the doctor for five minutes for the purposes of his opening statement. thank you very much mr. chairman. i commend the chairman and members of committee. ...

>> to develop when shuffling --dash influenza to be effective but antiquated we need to graduate into the 21st century recombinant technology is the tools to which we develop the universal flu vaccine is the way of the future. when you talk about influenza preparedness that marries you for the. for a pandemic.

i wrote an article getting into the problem of growing of eggs leading to a less effective vaccine to emphasize the need of a universal flu vaccine. so now there are some criticisms that are simple now but not fully appreciated before we really understood the structural buyout -- biology of these viruses. from the left-hand side is the influenza model. leading to one protein the molecule which is to the cell receptor that we get sick with the flu. in interesting things as a molecule of the head and the stem.

think of a mushroom with a cap. that is what the immune system responds again. that is the good news. the bad news is the head has many mutations that change from season to season. but the stem has few mutations the red dots are mutations so how do you make that response selectively against the part that does not change? and there is one example among many investigators at the nih have a situation now where they can take the molecule and shave off the head is called the head the stem but now they

use that to keep stable. now it is the nano particle. this is what it looks like 10 million times blown up. and it doesn't get distracted or a cell needed response against something that does not change. to have a workshop where we call together from experts of the united states to help us at nih with pathway to influenza vaccine. so just a few days ago we published a strategic plan at

the journal of infectious diseases to get to the goal over the last five minutes. >> ranking member and chairman and the members of the committee and for the preparedness response secretary to discuss influenza toward the development and availability of a flu vaccine now the director will hold authority and the deputy assistant and is a component of aspirin created to have countermeasures to protect people from the dire threat.

it is one of the most dangerous of those threats and it was established in the pandemic and all hazard act guided by a national strategy of influenza and what they can do to hire the best people with the best partners to be focused against influenza. to have 34 approvals or drug vaccine. and with those lore -- world-class production facilities shortening the vaccine time with diversified platforms most of that right here in america no one can

push the products to the marketplace. we are proud of the new flu vaccines now it is being produced in pennsylvania and north carolina connecticut, and new york. the world's first recombinant flu vaccine and we are not done yet. with pandemic influenza into the ever-changing virus. we are poised and partnered to make better flu vaccines they are usually so made with eggs although it is optimized it does not change much for decades and no match for rapidly changing virus. now making license vaccines

and could be more effective than the traditional egg -based. despite these advantages marketplace competition with the capacity for representing only a fraction on the marketplace today. there are actions to improve the influenza vaccine now with the long-term efforts with the universal flu vaccine. and with the industry partners to take the following steps with those existing vaccines we must expand the capacity to enhance effectiveness with the highest doses of antigen and with all age groups and then

continue the vaccine production process while we are grateful for that supplemental funding they have been fully obligated we have to sustain and to implement these steps with the threat that we face every year from the windsor in the near term it is only one piece of the puzzle equally important and then to treat six people. and then to represent a comprehensive approach with industry partners and we stand in a unique moment in time to

dramatically enhance the fight against influenza i look forward to working with this panel and the committee thank you for the opportunity to present today. >> now the next opening statement mr. gottlieb. >> thank you members of the subcommittee for the invitation to testify on the response of 2017 seasonal flu. this has been hard and i agree that investing and working towards universal flu vaccine is crucial but unfortunately where we are today in the development process that reality is many years off. while we should continue to focus on the discovery of a new vaccine to look at the enhance the production of many vaccines and why should be done then to meet global

demand. and the alternative to egg -based which is recombinant but in part because of the collaboration but despite these advances in development the majority of manufacturers are still continuing to produce egg -based. there are reasons for this it works and the vaccines are safe and effective. but even more so it would require enormous investment to change manufacturing but we believe with that, and it alternative him say are more efficacious than egg -based but more data and analysis is needed. one step to better understand the differences between the technologies using cms data to compare medicare patients that received cell -based compared to those that received egg

-based to see which was more effective and without alternative investment but there are challenges with these new cell -based approaches. and then to be better scaled of manufacturing and then to increase yield while increasing cost. and was cell -based recombinant vaccines it could be ramped up on short notice to allow us to more rapidly address those strains and getting all the necessary preparatory work is one step of the process. and then to facilitate such a transition was science -based

framework with those regulatory cool mom -- tools and then to be properly evaluated. ultimately with clarity for this new technology. that regulatory framework and then to transition to the cell -based manufacturing but as we prepare for next year flu season to analyze the data we are trying to better understand why this year was less effective but with that strain used by manufacturers although adapting circulating strains from the manufacturer leads to differences of the circulating strains and that from manufacturer and that could affect effectiveness the case is likely to be more complex.

and this is the first time we have seen them to be less effective. recent flu vaccines have proven on average to be only 33%. and with the manufacturing and technology and then to remember the importance to ensure that more people are vaccinated and we must also work hard that products used to treat each one -- treat the flu are available and we take steps to address any shortages. we remain committed overall aspects of flu response and i look forward to answering questions. thank you. >> thanks to each of you for your statement that is an incredible panel of witnesses your today with the entire

spectrum of people dealing with this issue. thank you for this time and education. asking the first set of questions, just quick responses especially this year has been difficult with severe flu season a lot of lives have been lost and many people have been hospitalized. would you get the vaccine or your loved ones? >> yes. every year and make sure my whole family does. >> same here. i got it this year and every year and as has my wife and children. >> absolutely. >> absolutely.

>> if you get the flu after getting the vaccine will that reduce the severity of illness work. >> yes there are studies that show reduce severity stomach that's true and an important point they say i did get the flu even though i was vaccinated but they don't realize it is possible that having gotten the flu without the vaccine would have wound them up in the hospital especially in the high risk group with complications. >> even though the most effective vaccine can reduce hospitalization. >> i have heard some concerns some individuals are worried they could get the flu from

the flu vaccine. is that possible? >> no. they cannot cause the flu. >> this is impossible. >> i agree. >> i agree. >> but there are those misconceptions out there so i want to make sure that people realize those facts going forward. so we have seen a lot of headlines about the flu vaccine reduced effectiveness. later he will ask questions why we saw this but first to ask about vaccine effectiveness this year for children. the effectiveness with 59% much better than adults. but why?

>> we don't have all the answers but there are a couple of explanations. children's immune response is usually better. and your response to the influenza vaccine may differ if that is the first time you are exposed to the flu or the vaccine you could have a better response. some people think the first influenza you are exposed to ever has a long-term effect we were very pleased to see the response in children this year. >> that? >> we have simplified the recommendations for children not everybody six months and over to get to doses we think

healthcare provider pediatrician we are using trusted channels of social media. >> we have seen the number of children has remained steady remains between 41 and 43%. how do we do that communicate the. >> but americans want us to be

open and honest and we can vent a spread

on those current methods of those egg -based methods and i will ask everybody else for their opinion and there are still scientific challenges to get the best recombinant dna technology in addition to the one that was used there are things that are better than that. i put in the strategic plan

with platform technology. the second one as doctor gottlieb mentioned whenever you have time-honored and works and is safe there is that inertia to make something of a major investment of resources to switch over from one to the other and make an investment. and we have got to go there. >> we had 70 years to optimize the efficiency for the egg

-based vaccine. it is remarkable to see the progress made in those companies to see that efficiency of production and another challenge to be blended together in the marketplace to get that differentiated data set of the egg -based vaccine we know those benefits the flexibility is critical for a pandemic response and to understand the true effectiveness.

>> and while we have commented we have better efficacy it is a case that in some years we have efficacy with that cell -based process so the egg -based process is effective and it works. >> it is also hard if you have a pandemic flu. >> but that was really worthwhile that the effectiveness h3n2 or that children are higher? so aside from funding, is there anything else congress can do? i remember years ago asking the same questions that

clearly we have to get to the gold standard. but with a continuous manufacturing and then enable them to come forward. >> it does go back to funding encouraging that technology without domestic capacity. >> and you have bipartisan support. >> i yield back. >> chairman of the energy and commerce committee. >> with crafting public policy

all day so the treatments that are available for individuals. if the antiviral drugs more effective the earlier they are given? with that replication cycle. >> last week the fda issued a release with the fruit products and we see efforts of mine to purchase products that

are making false claims when they are not approved for those purposes. what should they do? and to use that product certainly contacted the medical provider. >> and recently it was approved in japan the flu and just one dose are you familiar with that product if that is the case? >> i would just say that what the sponsor said publicly is

to submit an application and they currently disclosed they have studies ongoing. this act set a different replication cycle. with that potential opportunities appears to be earlier so the bottom line message we are interested in having a spectrum of antiviral drugs that act differently in case it becomes resistant to one approach we have backups and alternative approaches. >> i can add to that. so to develop this drug as well as other companies with antiviral drugs it is critical to note we haven't had a new

influence in over 20 years we rely on a single class although it continues to change and resistance to that class continues to emerge it is very concerning with avian virus to see high levels of resistance emerging to that class of drugs what is remarkable they took the lead to develop a new class the attributes of a single dose and to bring down the viral load and has a new mechanism action and then this drug would still work and also be used in combination and what else is exciting they have partnered with us-based company that has taken the

lead for discussions and consideration of approval and to transfer that knowledge of manufacturing the drug in the united states in the near term. as a a dozen are a half-dozen of promising candidates to make better treatments. >> and for the benefit of the chairman that this is extraordinary the company did this however the first recognition of this mechanism was in the paper from 1979 and the national academy of sciences from the nih. entitled transfer to the

influenza file during transcription. so basic science is the root of everything we do that 20 years later turns into a product made by a japanese country. >> that's good. that is why we did 21st century cures to continue that funding cycle. but my time is expired thanks for your good work. >> the chair recognizes the gentlewoman from illinois. >> thank you doctor fauci i think it is important to appreciate how much our researchers in the federal government contribute to address these. i have some basic questions

ordinary consumers. so can you tell us generally how easy it is to spread the flu virus person to person? >> it varies but of course this is one of the more infectious or contagious that we have. in the household spread is frequent and in schools through respiratory droplets that is why ucs say cover your nose when you cough or sneeze don't touch your eyes or mouth wash your hands frequently. >> how long is the person contagious? can he be contagious and not know it? mary before you develop

symptoms and 24 or 48 hours after the fever but it varies by virus. >> 24 hours or 48 hours after the fever goes down. the cdc recommends people stay home 24 hours after the fever breaks. according to the bureau of labor statistics 28% have no assets through paid sick leave and this is a problem for those in the lower income wage jobs. one third such as food preparation have no paid sick leave. and the united states is the only industrialized country without paid sick leave. can you explain why it is

important to stay home? >> we are trying to limit the spread of the virus is staying home will help you heal the keep you from spreading to others. >> in 2016 national bureau of economic research found it would prevent 100 infections per week. so when people can stay home they are less likely to get the flu. i know it's not your jurisdiction but some of those precautions are high -- hard to abide by if you are depending on the paycheck for that day. it is a public health issue. i also wanted to note that

heather holland a texas mother died because she could not afford the co-pay for tamiflu which was $116 she had insurance. would that have helped her if she took that in time? $116 for low income family is a lot of money even when insured. >> i can just say in response to antiviral medicines we work closely with manufacturers to learn that there was plenty of supply but it was branded

rather than the generics. there was some agreement by the pharmacy benefit managers to offer the generic at the preferred brand or generic which would give a long work co-pay but of course that is a very sad story. we don't know antiretrovirals will not cure a person but it shortens the process and starting quickly reduces severe complications. >> so affordable pharmaceuticals are very important issues we need to grapple with as we deal with this flu virus. thank you. >> the chair will not recognize the gentleman from virginia.

>> it has been very informative i appreciate your testimony. you are doing great things. this was timely on february 28 i had an e-mail from a constituent bringing up these issues and started talking about nano flu and how we could push that product forward and what he raised in his comment they have 40 done phase one human trials but they don't plan to do phase two until the third quarter of 2018 because obviously they want the flu to be out there and to test it. but he said i do not understand why the cdc and fda do not push a vaccine. it would seem to me that they

might push for phase two and australia this year and possibly phase three in the united states. that could make it available starting in the fall of 2019. if the government is serious under serious about speeding up the approval process and i asked the question because it makes sense so why are we using the australian flu season to start testing these new ideas? that there are 40 new products out there could we shorten that time. if we did some of it here or there with the opposite seasons? >> i will comment briefly i have not familiar with the drug you think it is recombinant vaccine. >> i believe it is.

but tested compared to the vaccine for senior adults of which i am rapidly approaching that category. [laughter] >> it isn't uncommon to see products tested in the southern hemisphere i'm not sure about that circumstance but that is a common phenomenon you will see them tested their. >> see you are not against it? mccue can pass on to anyone we will actively engage. >> it isn't testing in australia about the product is the nanoparticles going into phase one that i showed the model. the reason it will not go into phase two from the standpoint until the end of the year, is really a production capability

that doctor gottlieb referred to we haven't gotten efficient is the field. we don't have enough product to start a phase two until the end of 2018. it's not that the fda is holding us up but we don't have enough product. >> i appreciate that you make it is typical with any new vaccine it takes time with the influenza vaccine time that with an outbreak so as long as it is under the u.s. we are flexible to allow the companies to get that data wherever the flu may be in the world as long as it follows that process. >> i appreciate you helping me answer that question and mr. jones he would be pleased to hear that as well.

and the domestic supply offshore. >> we work very hard over the last year to invest great sums of money to develop these vaccines and get a license it is critical we expand the capacity that only to meet the seasonal market demand but also in a pandemic situation we cannot import vaccines from other countries so that domestic capability is absolutely critical. >> in my time is up so can you please let us know what we can do to assist to get more offshore production from

florida. >> thinking for everything you do to keep americans healthy and safe. now exiting peak season but entering allergy season. what i have learned over the past decade that they are longer and more intense, hotter days in florida and the pollen is already raging. what about families with children and vulnerable population on alert because of the intensity as they begin to deal with allergies? when is the appropriate time to head to the doctor's office? is it the onset of fever the question you are asking is the overlap. the recommendation from the

cdc is if you have symptoms that persist you want to go to a physician if you have a situation where you look like you are recovering then you have a left relapse that could be bacterial but if you fall into a risk category like pregnancy diabetes or a child should not hesitate to see a physician because that is the group that would benefit from the antiviral drug that is the reason why the cdc recommends that we do that and i call the we are pleased that pete is to have passed there is still a lot of blue out there and the

stream strains are more common now so look for fever but the warning signs i getting better very high persistent fever for children not being very responsive or hard to wake up. >> i continue to hear the refrain that they don't get it because last time it made him sick. that is the reason they don't get the flu shot. >> they don't cause the flu there can be some feeling of not feeling that well but if there is other stuff out there it isn't related to the vaccine itself there was respiratory virus we receive

in the clinical center at the nih that was before the onset of the flu people said i already got the flu wrong. anything you should get vaccine because there are other components that could protect you from what is circulating in an area for innovation that has more knowledge what they are exposed to in the home why we are trying to drive diagnostic into the homes of the patients to distinguish of it is bacterial or viral survey can take responsible action

showing 36% effectiveness how to reassess that had we test for a vaccine effectiveness what is that mean 36% effective is it true this is different for different age groups? to have a multistate network that they evaluate people who evaluate system --dash symptoms laboratory testing to have proven those who have those systems to compare vaccination history and then do the but the larger the more

we can look at the categories of the different types to do in terms estimate and end his investments if we have a larger simple we could more reliably look at the age groups whether cell -based or egg be the benefit to you and the family to make it is best way to protect yourself and your family against influenza some is not -- none. >> your recognize for five minutes.

>> while we are on the commercial to get your flu shot doctor fauci told me in december to get it and i did. it has been a tough fear back in texas but there hasn't been a new antiviral produced in the last 20 years? >> 1999. >> so then this question as far as the scientific side why is this so difficult? virus is a pretty simple organism talk about toxicity or on that paper it seems like that should be pretty straightforwar straightforward. >> it seems that way but there are targets in the replication

cycle as other inhibitors but the interesting thing is even though we do that fundamental base research we haven't had an overwhelming amount of interest to help to chaperone the companies and it isn't completely instrumental and to put all of that effort king at the various aspects we came up with a total of 30 effective drugs but the industry that we could not do the same thing. >> on that regulatory side can

you take that up? >> and there is a lot of interest to see those differentiated products for the strategic rationale to have that available but the centers for approval are relatively straightforward to products to put forward to address pandemic flu as well as seasonal flu. others that have been in early stages is they have been commercial challenges with the ability to get a commercial return on a product and i will remind the committee at the time the agency approved tamiflu the agency was criticized by many is that

what they are to be improving. and in some quarters not entirely. >> so your judgment about writing this prescription regardless of cost is only marginally effective with the side effects that you say that what doctor fauci referenced so to take these challenges on but you provide the market? >> on the marketplace for seasonal new is the marketplace there is a full appreciation of the impact and benefits to give the antiviral drug when infected with

influenza. there is a drug approved a few years ago there is still very little uptake it is single-dose iv administered. so there is the ability to develop antiviral drugs even to reduce the severity of illness. if the healthcare system doesn't appreciate that. >> talking about the viral load when ebola was causing the problems that rapid production caused a reaction and that was some concern. is that something with which you are concerned with these types of medications? >> we have not seen that with influenza or antiviral drugs

we believe it leads to less severe illness. with ebola as opposed to what you see mostly a local reaction you would not expect it with that. >> the gentleman from new york. >> welcome to the panel from the national immunization survey found that fewer than half of children and adults were vaccinated by november. only 40% fixed months and older received a flu vaccine. the numbers appear to be what they were the last couple of flu season but i'm interested in hearing from this panel why do you believe these numbers continue to be in that realm

and how do you approach that? >> data shows 60% did not have vaccination to make either the numbers that you are citing from november that is the early results but by the end of the season we will see that 40% get the flu vaccine much higher in the children around 60% and with influenza with a year like this everybody knows how bad it can be but then there are questions if the vaccine is helpful or not it is important for us in public health to remind people that vaccine has provided protection over 2 billion children and it is worthwhile.

>> what has your organization been doing? >> we do quite a bit of research on communication we have done 30 studies to understand what motivates individuals as well as what influences clinician to give a strong recommendation. with patients is a strong recommendation from their doctor. we see an increase of ob/gyn recommending it in pregnant women getting the vaccine once they saw how severe that was in 2009. but we but we have hit a wall right now. after this season there is concern the medical community or the public we don't know how that will react we are

testing messages for next fall we are using multiple channels traditional channels and social media. >> and i think there is a robust platform but with that recommendation to put out a number of our own to build on that. and to be very transparent what we are learning about the effectiveness and continue to remind consumers this vaccine till has efficacy against h1 and one that tends to peak later in the season so they are less efficacious it is still a lot of value to get vaccinated than you tend to see the upswing and as we see

right now. it is quite effective. >> with that 100% number, how important is it to reach that? >> with many vaccines there is direct protection or indirect protection the higher proportion that is vaccinated could be helping others not get sick. so the pediatric vaccination is important for the children and the adults that get it from their kids or grandkids. >> seen news reports that it was only 36% effective in addition social media has warned people against vaccination. does the cdc have a way to

track the media sources impact the number of people? >> we do assess attitudes periodically to understand if there are rumors that are resonating. asking why didn't you get vaccinating on -- vaccinated? that it isn't effective rather than concerns about safet

[inaudible[inaudible] >> thank you for joining our caucus. this will lead up to the hopeful reauthorization. during the cures debate we did get signed into law the return of contracting of authority to bartok. i'm curious, this was something we wanted restored it was in the original passage when it was

started but there's been some hesitation is that contracting authority yet been properly is stored since it was authorized and passed into law under 21st century cures. >> thank you. were it's critically important to put that in. it's not been finalized yet but it's part of an overall realignment and we look forward to the full implementation of that very soon. >> what is the hold up? >> the overall realignment. work on it implement this as quickly as possible. >> will continue to ask questions and so we hear what's authorized it that it has been implemented in the original it's

my understanding that they were also given transaction authority on the contracting process that could inhibit innovation and preparedness. his part to able to use the other authority that was in the original bill? >> we had been using other ones the process of getting other authorities is still a process cannot work on the effectiveness of that process now we are finding ways to use that effectively. >> with the reauthorization of poppa coming, and it's due to expire in september, and talk to me about the fiscal year 2018

request of 250 million of pandemic influenza. can you ask blaine apart up authorization of the program is beneficial assuming it is authorized would you agree? >> it is essential. >> can you tell us how it would be use to prepare for the next pandemic. >> a lot of work has been done are ready with the investment provided. we made great strides with our partners to make our country better prepare there's a lot of work to be done. we need to expand the access of vaccines we created so they're useful and available to all. we still need to develop new drugs. we need more options to treat people who are hospitalized with

influenza. we need to do a better job with our diagnostics as well. so that they can get treated sooner and take action to reduce the spread of the virus. all of the work is to be done we have to sustain the infrastructure so in the context of this and fill in the gaps that's how we would support. >> and can you talk about the importance of sustained and robust funding? sustain being the critical word here i lies that so critically important. >> we rely on these to be available in producing vaccine so that when we need it we need it quickly and they have the staff in place of the fda can

continue reviewing that facility it's in part and that we don't let them off the ball for sustainment. the factories closed we have no response. at the same time we must sustain our momentum in the face two and three studies for additional technologies for vaccines. for the -based so that we need them and we have them quickly when we need them for pandemic. >> california was hit hard this year by the flu season and in orange county they suffered with well over the cases than last year. they had at least -- and we all

know that seniors are particularly susceptible to the flu. the cdc states that at least 75% of flu related deaths occur with people 65 and older. my district is home to large retirement population. i'm concerned about the health of this group during flu season. while the overall effectiveness rate is 36%, it can rat very depending on age group. last year the effectiveness rate was 40% and the rate for seniors was only 25%. one will suspect it is lower for vulnerable populations like seniors but i noticed that the 201617 rate was more effective for children. some of my colleagues have asked what has accounted for the variability in flu vaccine among age groups.

what can be done to improve the effectiveness for seniors? >> there have been efforts to develop different products and others with weeper weaker immune systems one is a high dose a key strategy that we have is to make sure that people with high risk get properly treated with antivirals if they do we think that the have a poor response to many vaccines including flu. >> when we have an exit a possible pandemic we always test on healthy adults but also the elderly to make sure that the dose in the regimen gives the

comparable response that a younger person would have. the two major areas it's a much higher dose than what you give to a healthy young person as well as using a product that is not a vaccine but it booze the response to the vaccine. >> this is a lesson that we can transition to seasonal vaccine development. we know in the pandemic vaccine we have to have higher doses of antigen to make them immunogenic and effective across all age groups. in the last two weeks i visited the senior leadership of the license manufactures for the united states. i talked about the challenge about what their thoughts and strategies and how they can

improve the effectiveness of their vaccines. each is poisonous strategic and thinking about ways to increase their vaccine. they are partnered in useful in these to try to improve the effectiveness of the egg base vaccines. >> were actively looking at data for the relative effectiveness of the nf's 59 in regard to the regular vaccine if we do have differences relative to the flu vaccine it offers some clues as to why the vaccine overall was less effective in string too, will have that data available shortly. were working closely to drive those results i will make it

available as soon as we have it. >> in 2009 the fda approved a high-dose version of the vaccine for elderly individuals. there's a study indicates it was 24.2% more effective in preventing the flu in adults age 65 and older as compared to the standard dose faxing. can you elaborate on whether the high-dose vaccine would reduce flu related death among seniors? >> even 20 some percent superior responses still not 100% because of the weaker immune response that seniors get. we had the market of the higher dose product has been increasing since it's become available. cdc does now recommend a preference over the regular dose faxing. one thing we found is a vaccine

that we have at the doctors or pharmacy is that when you get because they might not be the other product if you are looking for. the additional studies with cms has helped us build this evidence base of what's the best way to protect seniors. >> the chair now recognizes the gentleman from texas for five minutes. >> thank you for allowing me to be here. i want to thank the chair for holding the hearing on the current flu season. the 201,718 has been the worst in recent years resulting in tens of thousands of deaths around the country. there has been some advances in viral drugs which can hopefully

both produce the number of people who get the flu and help those who do get it to recover quickly. i understand there's a new method based on recombining protein technology that makes it less likely for vaccine to mutate as it is ingrown. has supported this as well as the development of cell -based vaccine can you explain why they have chosen to support research on these instead of the egg -based? >> we primarily focus on supporting the new modern technologies to be able to respond faster and more effectively to pandemic response. we know you can cut out steps and you don't need a virus to grow and produce vaccines he can start from a gene sequence.

this affords greater flexibility and speed compared to egg base vaccines. were learning that investments in new technologies might offer advantages for more effective flu vaccine. what's critical is that it is one thing to licenses faxing the make them available but they're not available in sufficient supply and they're not penetrating the marketplace on those companies are frail and vulnerable at risk of going out of business after huge investment if that vaccine is not used. >> the data suggest some of the newer vaccine may offer greater protection is there enough data to recommend the silver others and if not what type of data what they need to make a recommendation? >> were still evaluating some of the data relative to the

high-dose vaccine was start to speculate on why the vaccine overall might have had left advantageous one of the theory you would put on the table is perhaps you might require a higher dose of antigen to have an immune response to something we need to consider among other possibilities about why we haven't seen a robust immune response from these generally. the one thing we did observe so far this season was at the vaccine produced about

20 million doses produced in cells and those appear to have provided more protection on a relative basis of 20% than the egg base vaccines. we are not sure of the reasons why. it leads to hypotheses about why maybe generally speaking we haven't seen has much room must response historically as we would want. >> and others new antivirals in the pipeline can you explain why these drugs differ from those currently on the market and how they might help us treat the flu in a new way? >> i think it's important to recognize the one class of drug is an inhibitor that binds to an active pocket that blocks a virus after it is replicated from the breaking away from the cell these new antiviral drugs are working on the replication

cycle before it reproduces itself. because they work at a different part of the virus lifecycle they can also be effective if the virus mutates and becomes resistant to the single class of drugs we have available today. it's critical we have the different approaches to the antiviral drugs. >> i know i'm out of time. i have other questions i'd like to submit a philosophy thank you for being here today. were looking for the light at the end of the tunnel. i appreciate you partnering with each other to deal with this. flu is terrible and there's a lot of other things out there. >> i remind members that they have ten business days to cement questions for the record.

i asked witnesses to respond properly should you get additional questions in writing. i thank you for your time today. it's very informative and i enjoyed the slide presentation. to visualize that and see how it's better to attack the stem instead of head and actually give you a good visual was very informative. one day will be in here discussing that universal flu vaccine that we know we all desire to see. i hope we continue to take steps even if their small steps to get to that conclusion. thank you for being here. the subcommittee hearing is adjourned. [inaudible]

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>> and the student cam competition we asked students to choose a provision of the alaska petition and create a video of why it's important. students competed for the chance to win cash prizes. we received 2985 entries from 46 states. the first prize winner for the high school east category is for montgomery blair high school. for no trespassing. seeking justice for native women. the first prize winners are will and james from whitefish bay high school in wisconsin. for wisconsin vote counts. a first-place winner for the high school west coast to the capital high school in boise, idaho for prison reform.

for survival of the space. the constitutionality of abortion. our judges special citation for creativity goes to -- william and dana for their documentary, be true to the constitution. finally, were happy to announce our grand prize winners. adam cook and tyler from dallas center grimes high school for, old enough to fight, old enough to vote. [inaudible]

>> with this year's topic it was an open-ended question so we had time to focus in. when i looked online and have the contact information for the person i thought this is -- we have to do it. so he sent e-mails and started filming. more e-mails and then everything fell into place. >> it was pretty difficult we looked at different amendments to evaluate there's a lot of controversy going on right now public so what has affected us as were heading to college next year i were able to get in contact with some important people here. >> the top 22 winning entries will air on c-span in april. you can watch every student cam documentary online at student

cam.org. >> next, here you to talk show host talk with recent dot-coms during liberty, a meeting of liberatory students with speeches from journalists business executives and entrepreneurs in washington, d.c. >> welcome to liberty calm. this is the 11th time but it's usually called the students for liberty conference. the other one is you, you come from all walks of life. all ages but what unites us tonight the ideas