good morning. this year, like so many previous years, we've had a bad flu season. after record breaking widespread flu activity, the cdc has reported the flu season has finally peaked. we're probably going to still see flu activity until the middle of april so if you have the flu or flu symptoms, it's important to see your doctor and stay at home. influenza is a 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 complications. since 2010, the flu has caused between 12,000 and 56,000 deaths per year. this year was no exception. tragically, as of february 24, there have already been 114 influenza-associated pediatric death this is season.

some of those deaths have occurred in my home state of mississippi. although we've enhanced our preparedness for the flu in recent years, there's still room for improvement. the best way to prevent the flu is by getting your flu shot. millions of americans receive a flu shot every year to help protect them against this illness. unfortunately, there are many americans that do not do that. last year, only 59% of children and about 43% of adults received flu vaccination. even though only a little over half of americans typically get vaccinated, cdc estimates that flu vaccination presented 3,000 pneumonia and influenza deaths during the 2015/2016 flu season alone, increasing the number of americans that get the annual flu vaccine will prevent more deaths and illnesses. not only can the flu vaccine help prevent an individual from getting the flu, but it also helps reduce severe outcomes when someone does get sick with the flu. during past seasons, about 80%

of flu-associated deaths in children have occurred in children who were not vaccinated. similarly, a recent study found that receiving the flu vaccine reduced severe outcomes and hospitalized patients by reducing deaths, reducing icu admissions, reducing icu lengths 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. the cdc announced this year's flu vaccine was only about 36% effective in preventing an individual from getting the flu. the vaccine's effectiveness varied from different age groups and for different strains of the virus. for 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% effective this season against the deadliest

strain of the flu, h3n 2. the vaccines reduced effectiveness against h3n2 is especially concerning. historically we have struggled to make an effective vaccine against 4 h3n2. for example, during 2014 and 2015, this committee checked the vaccine's effectiveness due to the mismatch between the strain used to develop the strain and the strain that was actually circulating. the h3n2 mutated. we must be able to rapidly detect and respond the changes in the challenging and circulating flu virus. according to the fda this year,

the vaccine's reduced effectiveness against the h3n2 virus was not caused by a mismatch. one factor that may explain why the flu vaccine was not that effective against the h3n2 strain is a mutation caused by the vaccine and egg adaptation through the egg-based manufacturing process. currently, about 80% to 85% of the flu vaccines are manufactured through the egg-based manufacturing process. when inactivated flu virus is grown in chicken eggs during the vaccine manufacturing process, genetic changes can occur in the virus that make a vaccine less effective in humans. some researchers think egg adaptation might be especially problematic for the h3n2 virus. of course there are many different factors that also might explain the flu vaccine's reduced effectiveness for h3n2. this issue needs to be thoroughly investigated so we can improve the vaccine

manufacturing process if necessary. and improve the vaccine's effectiveness in the future. appreciate the hard work and dedication of the people at hhs to improve our flu preparedness, including those at cdc, nih, aspr and fha. i look forward to today's testimony. the chair will recognize ranking mr. miss degette for purposings of an opens statement. >> thank you so much, mr. chairman. i'm always happy to have this flu hearing which we seem to do every year. looking at the witnesses, i feel like we're getting the band back together again to talk once again about what we can do. appreciate you all coming and i'm hoping that this year we can actually make some progress in talking about all of these issues that the chairman mentioned. we had -- we've had in this

subcommittee seven hearings on flu preparedness since 2004. most recently in 2015 we had two hearings after the country was hit with a particularly severe 2014 and 2015 flu season in which the h3n2 strain predominated. this year again we're experiencing a severe flu season caused by the h3n2 and that's a stark reminder of how the flu is very, very serious. hospitalizations have been high throughout the country. 114 children have died. as an example, my home state of colorado set two records, not good records with nearly 4,000 people hospitalized due to flu and 160 flu outbreaks in long-term care facilities. this year's flu vaccine was only 36% effective and that's of

concern. even i had the flu and i had my vaccine, too. and so this really is something that one would think in the year 2018 we would be able to tackle in a more meaningful way. i understand that the fda's flu vaccine -- the vaccine advisory committee just met to make recommendations for next year's vaccine. i'm looking forward to hearing from the fda about how data on this year's vaccine effectiveness helped to inform the decision making for next year. i'm also hoping as usual to hear more about research efforts to produce a more broadly protected vaccine or even a universal vaccine that can target all strains of flu and mr. chairman we've talked in these various hearings over the years about the egg-based vaccines and the mutation of the virus within the egg is only one of the problem with egg-based vaccines.

when you look at the more remote but yet very real threat of a pandemic flu, if you're relying on egg-based vaccines you can't be very nimble in producing vaccines in an effective and fast way. this year, if it's any good news 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. so until we fix this system in a broader way, the flu vaccine is still our best tool.

unfortunately, the number of americans who got a flu shot this year hasn't changed from our last hearing in 2015. i'm hoping that's another thing we can discuss, about how we can persuade people to get the vaccine and concrete steps we can take next year. as i said, we also have to work towards better treatment methods, in particular more effective anti-viral medications so that people who do become sick can be cared for before their 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 that are in the pipeline and also maybe they can talk about some of the shortages we saw this past season. finally, the importance of a strong public health infrastructure cannot be overstated. because of the critical work of federal and state public health experts, we are always in a good position but there's still more that needs to be den and i'm

looking forward to hearing how we can coordinate our strategies across all levels of government. so, mr. chairman, again, i want to thank the witnesses who are hear today, some of which i've worked with for years. they are 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. thanks, and i yield back. also, i'd ask unanimous consent to put mr. palone's opening statement in the record, he won't be able to come today. >> without objection. the gentlewoman yields back. chair recognizes the chairman of the full committee mr. walton for the purposes of an opening statement. >> i thank the chairman and i thank our witnesses for being here today. this has been i think one of the most severe flu seasons the united states -- that we've seen. nearly 50,000 people died in a single season. today we're currently experiencing a severe flu season with a predominantly deadly strain by all accounts. it's vital to find ways to reduce deaths and hospitalizations from this challenging and changing virus.

at energy and commerce and this subcommittee in particular we have a long history as you've heard of conducting these oversight hearings and trying to be as helpful as we can to you all as we work on the public policy. during our last hearing in november of 2015 we explored many important issues, including how the department of health and human services could help improve our ability to respond to seasonal truck in seflu vacc mismatches. most have been made through an egg-based process and we've seen some innovation in the manufacturing of the annual flu vaccine. the fda approved the first flu vaccine manufactured using cell culture technology in 2012 and the fda approved the first flu vaccine manufactured using recombinant dna technology in 2013. in addition to new manufacturing technologies and methodologies, we've also seen new types of flu vaccine made available for the

american people. historically flu vaccines have been offered to people to protect against three different stains of flu virus and in 2012 the fda approved the first flu vaccine that offered protection against four different strains. in '09, the daef aapproved the first high-dose flu vaccine for older adults and some data show the high dose flu vaccine is more effective in older individuals than the normal dose. now that we have different ways to manufacture the flu vaccine we need to have make sure we have enough data to make sure we're make the most effective seasonal flu vaccine possible. the cell-based flu vaccine might be more effective in preventing the flu than the egg-based vaccine this season. we need to understand why that might be and why there are differences in effectiveness so we can approve manufacturing processes as necessary. as subcommittee chairman harper has said and emphasized, the annual flu vaccine is still the

best defense. every year thousands of people are saved because they get the vaccine. if you do get the flu, there are anti-virals. i can't remember a season where more people i know say they got tamiflu or whatever the anti-virals are so that's an important part of this as well. i'd love for you to talk a bit about what has been in the press about the japanese product that might cut off the flu even sooner and what you see on that one if anything. one day we hope to have a universal vaccine. we're encouraged about a 125 t.j. i c -- strategic plan. i yield the remainder of my time to the chairman of the health

subcommittee, 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 our district with astonishing force this year. the district that i represent in north texas, our public health departments were strained, we had schools that were closed temporarily to prevent the spread of flu amongst children. since the start of the season, more than 400 people in my area have been hospitalized as a result of the flu, 12 reported to influenza-associated deaths including one pediatric death. dr. n the timing of this particular hearing is appropriate given that we are just past the peak of flu season and now people are working on the development of next year's vaccine rand we're 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. i yield back. >> the gentleman yields back. i ask unanimous consent that the members' written opening statements be made part of the record and without objection will be entered into the record. additionally, i ask unanimous consent that energy and commerce members not on the subcommittee on oversight and investigations be permitted to participate in today's hearing. without objection so ordered. i'd now like to introduce our witnesses for today's hearing. first today we have the acting director for the center s s for disease control and prevention. we welcome you today. second, we have dr. anthony fauci, the director of the national institute of allergy and infectious diseases at the national institutes of health. then we have dr. rick bright, the deputy assistant secretary for preparedness and response and director of the medical advances research and development authority at the office of the assistant

secretary for preparedness and response, which means there's no way that gets on a business card. but we're glad to have you here. and finally, the honorable scott gottlieb who serves as the commissioner for the u.s. 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 the committee is holding an investigative hearing and when so doing we have the practice of taking testimony under oath. does anyone have an objection to testifying under oath? seeing none, the chair then advises you that under the rules of the house and the rules of the committee you're entitled to be accompanied by counsel. do any of you desire to be accompanied by counsel for the purposes of today's hearing? seeing none i , if you would ple rise, raise your right hand and i will swear you in. do you swear the testimony you are 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 and you may now each give a five minute summary of your written statement and we will begin first with dr. shukit and you're recognized for five minutes. >> good morning, mr. chairman and members of the committee. influenza is a formidable adversary, the virus is ever changing, it's with us every year, and it's too you have been able to outsmart our immune systems. we've worked with the cdc 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've made we have much more work to do. i'll provide brief information on what we are doing to prevent influenza. this has been a severe season. hospitalizations have broken records. hospitalizations were as high as we've seen during the pandemic of 2009. too many children have died already from influenza this season. we had intense activity in virtually the whole country at the same time and that contributed to the spot shortages of anti-virals. we are not over with the season. disease is decreasing but the b-strains are starting to be as common as the h3n2 strains.

as you've heard, the vaccine effectiveness this season was lower than usual. it was at 36% over all. even lower for the h3n2 strains that dominated. children did receive 59% effectiveness in children and 50% effectiveness against the h3n2 strains, a reminder that vaccinating children can be life-saving against flu. sadly, the vast majority of children who die from influenza have not received any vaccine at all. there are many theories about why influenza vaccines work less well against the h3n2 strains. one theory is there changes that occur in the processes of developing the vaccine. there may be differences in effectiveness based on prior immunization or prior explosion your flu strains. we're still characterizing the viruses for this year.

we do not think there was antigenic drift but there may be some changes in the virus that could account for the severe season. that's still under study. some vaccine is better than no vaccine protection. we wish the vaccines worked better but we do know the vaccines are providing protection to many and they're mitigating the severity of the disease. cdc has three objectives in our work with vaccine. we want to makes mize use ximiz current vaccines, we want to support the nih's leadership in developing a universal vaccine and we want to improve the current vaccines we have. we have made significant progress since the 2009 pandemic. we have more data than ever before. we have more information on vaccine effectiveness from our multistate network. we're producing more potential vaccine candidates. we're collecting more information on the genomic

characteristics of the viruses using next-generation sequencing. we are working with pharmacies, long-term care facilities and ensurers to address the spot shortages of anti-virals and were able to smooth things out a bit during this season. but we know people were still frustrated. but despite the progress we've made, there is much more to learn about influenza and we think that investing in that learning can have direct implications for prevention and control. in closing, i know this has been a difficult flu season and a heartbreaking one for too many families. flu continues to be a priority for the cdc. we are literally working 24/7 on this issue and we are all, across hhs, committed to working together to find ways and tools to help americans reduce their risk of getting sick. i look forward to answering your questions. >> thank you very much. the chair will now recognize dr. fauci for five minutes for the purposes of his own opening statement. >> thank you very much, mr. chairman, ranking member

degette, chairman walton, members of the committee, thank you for giving me the opportunity to talk to you about the role of the national institute of allergy and infectious diseases at the nih in addressing seasonal and pandemic influenza. does this work? no? it does. where do i point it at? you? doesn't work. can you advance it, please? next slide. as you can see, as i've testified before this committee multiple times that the nih research in this case in influenza is multifaceted involving basic research, research resources, clinical research, ultimately with the development of countermeasures in the form of diagnostics, therapeutics and vaccines. for the purpose of today's discussion i'll focus only on vaccines. if i could have the next slide. as seen in this slide, as mentioned before -- and let me start off by reiterating what you said, what mr. getty said and what ann schuchat said, it

is always better to get vaccinated than not. but in that reality, we can do better with the vaccines that we have because the current influenza vaccines are not consistently effective. we have an example of that this year. also pandemics occur and our responses are generally not very effective. we've seen that with the 2009 pandemic flu and we continue to chase after potential pandemics like h5n1. we need to improve the production of these from egg-based to cell-based to recombinant dna technology. i'll get back to that in a moment and we need to, as anne mentioned, to develop universal influenza vaccine for broad coverage. next slide. egg-based technology is time honored, indeed. it has been effective, but it's antiquated. we need to graduate into the 21st century.

cell-based is better but recombinant dna technologies that i'll get into a moment which will be the tools to which we develop a universal flu vaccine is the way of the future. next slide. when you talk about influenza preparedness, that marries you to getting ready for a pandemic. i wrote an article just recently when we got into the problem of the growing in eggs with the adaptation in eggs leading to a less effective vaccine to emphasize the need for universal flu vaccine. next slide. let me talk to you about that. there are mechanisms that are simple now but nonetheless were not fully appreciated before we understood the structural biology of these viruses. on the left hand part of the slide is an influenza model, that's the virus. the arrow points to one protein, the he ma glute anyone molecule which is the part that binds to

the cell receptor that gets you and i sick when we get the flu. a very interesting thing was noticed several years ago. if you want to emphasize this, think of a broccoli with a head and a stalk or a mushroom with a cap and stalk. that head is one that has many mutations that change from season to season. the drift that dr. schuchat spoke about and that miss degette spoke about. the stem, however, has few mutations, the little red dots are the knmutations, so how do u make a response selectively against the part of the virus that does not change as opposed to one change? next slide. there are a number of ways of

doing that. i'm going to just show you one example among many. investigators at the nih and funded by the nih have a situation now where they can take that molecule, that hemagglutinin and essentially shave off the head. it's called a headless stem. now, normally that would fall apart. but it doesn't fall apart because investigators at the vaccine research center have made mutations in the molecule to keep it stable and we've put it on what we call a nano particle. that's on the far right of the slide. this is what it looks like ten million times blown up. so this is a little particle, but all of these are stems so that when the immune system sees that it doesn't get distracted about anything else and it focuses in on making an anti-body or a cell-mediated response against something that does not change. next slide. now, we recently in june of this

year had a workshop in rockville, maryland, where we called together experts from the united states and throughout the world to help us at nih to develop what we call a pathway to a universal influenza vaccine. next slide. i'm happy to say that just a few days ago we recently published our strategic plan and our research agenda in the journal of infectious diseases to help us get to the foal i've just been describing over the last five minutes. thank you. >> thank you for that testimony. dr. bright, we'll recognize you for five minutes for the purpose of your opening statement. >> thank you chairman harper, ranking member degette and distinguished members of this committee. thank you for the opportunity to speak with you on behalf of our assistant secretary for preparedness response. t aspr. i'm rick bright, the director of the bio medical advanced

research development and authority, known as barda. aspr's mission is to save lives and protect americans from 21st century threats. barda is a component of aspr to ensure we have countermeasures to protect people from the dire threats we face as a nation and make no mistake, influenza is one of the most dangerous of those threats. barda was established and empowered with special authorities in the pandemic and all hazards preparedness act guided by a national strategy on pandemic influenza and largely funded through supplemental appropriations. we have proven what can be done when the government is able to hire the best people, work with the best partners and remain focused on a strategic fight against influenza. we have shown that the barda model works. with our industry and our federal partners, barda has achieved 34 approvals from the

fda for drugs, vaccines and diagnostics against a wide range of threats. we have increased domestic flu vaccine capacity in world class production facilities. we have shortened the vaccine response time with modern technologies and we have diversified vaccine production platforms. most of that right here in america. no one can rival barda's success in expanding capacity in pushing new products to the marketplace. we are proud of these new flu vaccines and they are being produced in pennsylvania, north carolina, connecticut and new york. these include the world's first recombinant flu vaccine and the first largest cell based vaccine production facility. we are not done yet. everything that barda and our partners have done and accomplished for pandemic influenza can make our seasonal influenza vaccines better and more responsive to the ever-changing virus. building on our success, we are poised and partnered to make better flu vaccines available

right now. most vaccines today are still made in eggs. although the process is optimized for efficiency, it's not changed much for decades and it's no match for a rapidly changing virus. cell and recombinant based technologies are used to make licensed vaccines and they offer speed and greater flexibility and may even be more effective than traditional egg-based vaccines. despite these advantages, marketplace competition and limited domestic production capacity have largely kept these approaches on the shelf representing only a fraction of the seasonal vaccine on the marketplace today there are actions to improve influenza vaccines now that can produce near-term benefit in parallel with the long-term efforts being undertaken across the government to develop a universal flu vaccine. to make better, faster flu vaccines now, we propose in

collaboration with our industry partners to take the following steps to improve the effectiveness of our existing vaccines. first, we must expand domestic capacity of cell and recombinant based vaccines. second, we must enhance their effectiveness with the additions of higher doses of antigen, we need to conduct clinical trials to expand their use in all age groups and finally we need to continue modernizing the vaccine production processes for speed and flexibility. while we are grateful for the supplemental funding that disrupted the status quo and fuelled our progress, those funds have been fully obligated. to win this battle, it is critical that we sustain these hard-won gains and we implement these steps to reduce the threat we face every year from influenza. in the near term, vaccine improvement activities are one piece of the puzzle. equally important is the ongoing work funded by barda to develop diagnostics that can detect influenza sooner as well as more

effective drug treatment options to treat sick people. these priorities, combined with improved vaccines represent the comprehensive approach to protecting the nation and the world against influenza. together with our federal and industry partners we have made tremendous progress, however the threat remains. we stand at a unique moment in time where we have tools and capabilities to enhance our fight against influenza. i look forward to working with this panel, our committee, your committee and congressional colleagues, thank you for the opportunity to present to you today. >> the chair now recognizes scott gottlieb for five minutes for the purpose of his opening statement. >> thank you, mr. chairman, ranking member degette, members of the subcommittee. thank you for the invitation to testify on our response to the 2017/2018 seasonal flu. this flu season has been particularly hard. i agree with my colleagues that investing in and working towards the universal flu vaccine is crucial.

given where we are today in the development process, that reality is still many years off. while we should continue to focus on the discovery of a new break through vaccine, we must also consider what immediate and intermediate steps we can take to enhance the production of existing licensed vaccines. and what should be done to invest and advance domestic manufacturing to ensure new and existing technologies are scalable so that manufacturers meet domestic and global demand. there have been successes in developing alternatives to egg-based vaccines such as cell-based and recombinant technologies in part because of the collaborations and work by barda. however, despite these advances, the majority of manufacturers are still continuing to produce egg-based vaccines. the reason is that the egg-based process works and the vaccines are safe and effective but even more so it would require an enormous investment to fundamentally change manufacturing. however, we believe it's worth

better understanding the potential of cell-based or recombinant vaccines. some say they could be more efficacious than egg-based vaccines but more data and analyses are needed. as one step to better understanding the differences between egg-based and cell-based technology s we're using cms data to compare medicare patients that received cell-based vaccines to those who received egg-based vaccine to determine which vaccine was more effective in that population. as we consider greater investments in alternative vaccine development processes, it's important to note, however, that there are also challenges with these new cell-based approaches. to help address these challenges, fda is working to help develop more effective cell lines that can be better scaled through continuous manufacturing. we're also looking at how we develop a more robust recombinant manufacturing process to increase yield while reducing cost. continuous manufacturing holds great progress for cell base and recombinant vaccines because

supply can be ramped up on short notice. this would allow us to more rapidly address newly emerging strains or strain drift. getting all the necessary preparatory work done is one limiting step of the egg-based processes. the fda can help make improvements to facilitate such a transition. we need to develop a science-based framework that includes the regulatory tools and guidelines for products to be developed in these systems and to be properly evaluated and our investment will provide regulatory clarity for this kind of new technology. this regulatory framework can increase the efficiency and reduce the costs of transitioning to this kind of new cell based and recombinant product manufacturing developing. as we prepare for next year's flu season and analyze the data for this year, we're trying to better understand why this year's vaccine was less effective against h3n2. at fda's recent advisory committee meeting, the data presented continue to suggest the strains selected for the

2017 and 2018 vaccines and used by manufacturers reasonably matched the circulating strains. this include the h3n2 strain. although adapting circulating virus strains for manufacture can lead to differences between the circulating strains and the one used for manufacturing, and although those changes could affect vaccine effectiveness, the case this year is likely to be much more complex. and this year is not the first time we've seen vaccines be less effective against h3n2. recent flu vaccines have proven on average to be only about 33% effective against the h3n2 viruses. given this, we're looking at several factors to better understand why effectiveness tends to be lower against this strain as we continue to invest in the future of manufacturing and vaccine technology, we also need to remember the importance of simply ensuring that more people get vaccinated with available vaccines each flu season and we must work hard to ensure products used to treat the flu, including anti-virals

a an an and saline is available. i look forward to answering your questions today. thank you. >> thanks to each of you for your opening statements. this is an incredible panel of witnesses that are here today that cover the entire spectrum of peach that are daily dealing with this important issue, so thank you for this time, this education you're giving us so i'm going to recognize myself to ask the first set of questions. and this is -- for each of you for quick responses, if you would just reply to this. this year has been an especially difficult and severe flu season. a lot of lives have been lost and many people have been hospitalized. would you get the vaccine and have your loved ones get it also. >> yes, i get the vaccine every year and make sure my whole

family does. >> same here. i got the vaccine this year and every year over the last many years as i can remember has my wife and three children. >> absolutely. >> absolutely, sir. i go to the pediatrician with my children and the pediatrician gives it to me and gives it to them. >> that's great. if you get the flu after getting the flu vaccine, is having gotten the flu vaccine likely to reduce the severity of the illness? >> yes, there are studies now that have shown reduced severity following immunization even when the disease itself isn't prevent prevented. >> that's an important point many people don't appreciate because they say i did get the flu even though i got vaccinated. they don't realize that it's likely -- not likely but it's possible that having gotten the flu without the vaccine would have wound them up in the hospital, particularly if they were someone in the risk groups that are more probe to getting complications. >> absolutely.

there's data to support that the vaccine even if it's not the most effective vaccine still does a lot to reduce the severity of illness, reduce hospitalization. >> i would echo those statements. >> great. now i've heard some concerns that some individuals are worried that they may get the flu from the flu vaccine. is that possible? >> no, the flu vaccine has not caused the flu. >> very few things that you say are impossible but this is impossible. >> i agree as well. >> there are those misconceptions out there and when i had this esteemed group here i wanted to make sure that people realize those important facts going forward. dr. schuchat, if i may talk to you for a moment, this year we've seen a lot of headlines about the flu vaccine's reduced effectiveness.

later we'll ask why but first i want to ask about vaccine effectiveness for children this year. you had answered the effectiveness of that was 59% effective, much better than it was in adults but why was it more effective on children than it was older adults? >> we don't have all the answers but there are a couple possible explanations. one is children's immune response is often better than adults, particularly better than older adults. a second is your response to an flu vaccine may differ from the first time it's ever been exposed to influenza or the vaccine. you may have a better response. some people think the first influenza you're ever exposed to through the vaccine or the nature has a long-term effect on your immune response but we were very pleased to see the better response in children this year. >> how do we communicate that?

why is it especially important for school-age children to get vaccinated? how do we communicate that and you would agree that's true? >> we have simplified our recommendations for children and now we recommend everybody six months and over get a flu vaccine every year. the first time you're getting a flu vaccine if you're a young child you're supposed to get two doses of the vaccine. communication about vaccination has to be multisectorial. we think the health care provider, pediatricians are the most important influence on kids getting vaccinated but we also use trusted channels, social media, other influencers. >> we've obviously seen the number of children receiving the fluke -- flu vaccine has remained steady at just under 60% of adults, between 41 and 43%. so how do we do that not just for children but adults also to

communicate the importance of being vaccinated with the flu vaccine? >> there's a nuanced message because being open and honested is really important and not promising that the vaccine will cure cancer, although we have a vaccine that does that, actually, the hpv vaccine. but i think americans want us to be open and honest about vaccine information. we know flu vaccines can prevent disease and reduce severity and we know they can also prevent spread. children are very important in getting flu disease but also in spreading it so getting higher coverage among children is in the whole public's interest. >> that's great. thank you very much. the chair now recognizes ranking member degette for the purposes of questions. >> thank you, mr. chairman. dr. fauci, i think everybody on this panel agrees with you when you said we need to get away

from the antiquated production model which the egg is and i know the chairman particularly appreciated your slide show. he's new to this subcommittee so he hasn't seen it before and he told me he was a chemistry major so i'm happy to have him to educate me. the -- the recombinant-based vaccine was only 3% last greer what i understand. i'm wondering if you can talk to me what the barriers are for moving from the current methods that we have, the egg-based methods which are used for the majority to this cutting edge vaccine and i'm going to ask everybody else for their opinion, too. >> i think there are a few barriers at least two. one is that there are still scientific challenges to get

recombinant dna technology and there are three or four or five in addition to the one that was used in the 3% from protein sciences, the flu block. there are things that are even better than that. so we need -- and that was part of what i put congressman to get in the strategic plan that there are scientific gaps in the arena of what we call platform technology, different types of vaccine. that's the first one, scientific obstacle. the second one that's important is that wherever you have, as dr. gottlieb mentioned, wherever you have something that's time-honored and works and is safe there is an understanding, fundamental underlying innertia for companies to make a change towardsing? which they'll have to make a major investment in resources to switch over from one to the other because you have one that you know that works, one that you know is safe. you have to make an investment. but the thing that i think we

need to emphasize is that we've got to go there. we can't stay stuck in the old technologies. >> thank you. dr. bright, do you want to add to that? >> i think everything dr. fauci said is spot on. in addition to those, it's about the capacity and the yields of the new technology so we've had 70 years to optimize the efficiency and the yields with of egg-based vaccine. we've had five years to work on optimization of recombinant and cell-based vaccine so it's remarkable to see the progress being made in those companies to improve the efficiency of production and the yields of those vaccines. another challenge, however, is the benefit of the vaccines is blended together in the marketplace so it hadn't been a focus on getting the differentiated data set to show the benefit and effectiveness of egg-based or non-egg-based vaccine. we know the benefits of non-- g

non-egg-based vaccines. we're also get the additional data now to understand the true effectiveness difference. >> so dr. gottlieb, did you want to add anything? >> i agree with my colleagues. with if recombinant processes, one of the challenges is still the cell culture and yield you're able to derive using recombinant process and while we've commented that we observe cell-based vaccine, it's true that in some years we have better efficacy with the egg-based process so the underlying message is the egg-based process is safe and effective, it works. the challenge with it is it's hard to scale and make a mid-season change. >> and it's also hard if you have a pandemic flu that hits. i'm wondering if any of you can -- doctor, did you want to add? >> the effectiveness on vaccine

studies are worthwhile, it's only recently we could tell you the effectiveness against h3n2 is less than against h1n1 or that children have higher effectiveness -- >> so aside from funding, i'll ask any of you, is there anything else congress can do to move this along? i remember years ago asking the same questions. i've glad we've made some progress. clearly we have to get to the gold standard. >> if i may quickly comment, congresswoman, as part of the president's budget, we put forward a proposal to make investments in continuous manufacturing. that was geared toward this kind of an opportunity to try to establish the regulatory parameters to enable these innovations to come forward. >> anyone else? >> it does go back to funding in some ways but just the support to encourage the movement to the modernized technology in addition to expanding their domestic capacity so we have them when we need them. >> i think you can say we have got bipartisan support for that

on this committee. >> that true. >> the chair will recognize chairman of the energy and commerce committee for the purposes of questions. >> thank you, mr. chairman, thanks to our very distinguished panel of witnesses not only for your help in crafting public policy but also the great work you do everyday to improve the lives and health of americans and frankly people around the world. dr. gottlieb, one of the treatments available for individuals who get the flu is the anti-virals. we've talked some about that today. are anti-viral drugs more effective the earlier they are given? >> they are, congressman. and how do they work? >> they currently are available -- it currently works by blocking a different step in the replication cycle of the virus itself than the one the vaccine targets. the vaccine targets the ability

of the virus to attach to the cell membrane and lungs. >> all right. and last week the fda issued a press release warning of fraudulent and unapproved flu products. why did you feel that press release was necessary to warrant consumers to be cautious? >> we see a lot of efforts online to try to entice consumers to purchase products we know are fraudulent that are making false claims, false and misleading claims, that are claiming to have anti-viral and anti-flu effects when in fact they are not approved for those purposes, including dietary supplements. >> and if consumers feel like they've been defrauded, what should they do? >> well, they should certainly -- i think any consumer that feels they might have used a product that was making an inappropriate or fraudulent claim should certainly contact their medical provider and certainly refer the information to fda. >> and recently, as i mentioned in my comments at the beginning, a new anti-viral drug was

approved in japan or is in that process that supposedly has the potential to treat the flu in just one dose. are you familiar with that product? can you talk about whether that's the case and what we might see here? >> i'm familiar. i would defer to my colleagues on the panel a little bit. i would say what the sponsor said publicly is that they plan to submit an application at some point this year and they have disclosed they have studies on going in the u.s. this is a drug that acts at a different point in the replication cycle than the other drug you referenced so it's differentiated and the other potential opportunity is the on set of action appears to be earlier than the currently available anti-viral. the bottom line message is we are interested in having a spectrum of anti-viral drugs that act differently at different points in the virus in case the virus becomes resistant

to one approach, we have backups and alternative approaches. >> other members of the panel want to comment on that specifically? >> they've been engaged with this company developing this drug for quite some time as well as other companies that were developing new classes of anti-viral drugs for influenza. it's critical to note we have not had a new class of anti-virals approved for influenza in 20 years. we rely on a single class of influenza anti-virals now and the virus continues to change and resistance to that class of anti-virals continues to emerge. it's very concerning in avian influenza virus such as h5n1. so it's remarkable this company took the lead. it has attributes of a single dose instead of five days at twice a day dosing. it brings down the viral load in the patient very rapidly, faster than the currently approved

anti-viral drugs and it has this new mechanism action so if a virus becomes resistant to the only approved class of drugs we have now, this drug would still work. and it could also be used potentially in combination with the existing class of drugs. another thing exciting is they partnered with a u.s.-based company. that u.s.-based company has taken the lead in bringing that to the fda for discussions and consideration for approval in the united states. and their plans are to transfer the knowledge and capability to manufacture that drug in the united states in the near term. so it's one of a dozen or half dozen promising candidates with new mechanisms of actions, several supported by barda and even anti-bodies to make better treatments for flu. >> dr. fauci. >> i can't help myself on this, mr. chairman, for the benefit of chairman harper is that rick bright said that this is very

extraordinary, that the company did this. however, the first recognition of this particular mechanism was in a paper from 1979 in the proceedings of the national academy >> by the national institutes of health. entitled "transfer of five prime terminal cap of globulan to complementary rna during transcription." it goes to show you basic science is the root of everything we do, even something that 20 years later turns into a product made by a japanese company. thank you. >> we'll let you -- that's good. you know, that's part of why we did 21st century cures, to continue that funding and that cycle. i was hoping to ask a question about domestic manufacturing of vaccines and threats and opportunities, but my time is expired. thank you again for your good work and for being here. >> gentleman yields back.

chair will now recognize the gentlewoman from illinois for five minutes. >> i want to thank you, doctor, for that addendum and the information. i think it's really important to appreciate how much our researchers and the federal government contributes to addressing these. so i have some basic questions as just an ordinary consumer and person. i think you might be the person to ask. can you tell us generally how easy it is to spread the flu virus person to person? >> yeah, it varies by strain, but of course this is one of the more infectious or contagious viruses we have. so in a household, spread is frequent. in a school, spread is frequent. it can be spread through respiratory droplets or on your hand. that's why you've seen us so many times, cover your nose when

you cough or sneeze and don't touch your eyes or mouth after you're, you know, with your hand, sort of wash your hands frequently. >> and how long is a person contagious with the flu? is it possible for a person to be contagious and not know it? >> you can be contagious before you develop symptoms, and usually we say about 24 or 48 hours after the fever goes down. again, with influenza, it varies by virus and year, but that's sort of the general facts. >> 24 hours to 48 hours after the fever. >> after the fever goes down. >> goes down, right. so the cdc recommends that people stay home for 24 hours after their fever breaks, but i wanted to point out, according to the bureau of labor statistics, 28% of workers have no access at all to paid sick leave. this is particularly a problem for those in the lower income --

lowest wage jobs. one-third of lower paid workers, including those who work in fields such as food preparation, have no paid sick leave. and in fact, the united states is the only industrialized country in the world without paid sick leave. i leave this to anyone, really. can you explain why it's important for people to stay home when they're sick? >> we're really trying to limit the spread of the virus. so staying home while you're sick will help you heal but also keep you from spreading to others. >> so in 2016, the national bureau of economic research found that if paid sick leave were mandated, it would prevent 100 flu-like infections per week for every 100,000 people. so when people can stay home when they're sick, people are less likely to get the flu. so i know this is not your jurisdiction, but i think it's

just important to note that some of the cautions we suggest for people are really hard to abide by if you are depending on that paycheck for that day. i think we need to think about it. it's a public health issue. paid sick leave is a public health issue. i wanted to also note that heather -- what's it? heather holland in texas, a texas mother, 38 years old, died because she could not afford the co-pay for tamiflu, which was $116. she had insurance. so this was a co-pay. so first of all, tamiflu, would it have helped her if she took it in time? and what do we say about that? $116 for low-income family is a lot of money, even when insured.

can someone comment on that? >> i can -- okay. yeah, i can just say that in response to the spot shortage of anti-viral medicines this year, we work closely with manufacturers and pharmacies and insurers and learned there was actually plenty of supply, but much of what was available was brand product rather than the generics. we did, in the midst of the season, get some agreement by pharmacies or the pharmacy benefit managers and insurers to offer the generic as preferred brand or as -- sorry, to offer the brand as either generic or preferred brand, which would give a lower co-pay. but of course, you know, that's a very, very sad story. we don't know that anti-virals will cure a person. the best data suggests they shorten the course of illness. being able to start them quickly is what we think helps reduce the severe complications. >> so in conclusion, let me just

say paid sick leave and affordable pharmaceuticals, very important issues that we need to grapple with as we put in context this flu virus. thank you. >> gentlewoman yields back. the chair will now recognize gentleman from virginia, mr. griffith, for five minutes. >> thank you very much, mr. chairman. this has been very informative. i appreciate all the testimony. you all are doing some great things. it was timely, on february 28th, just a week or so ago, i got an e-mail from a constituent who apparently keeps up with a lot of these issues, and he started talking in his e-mail about nano-flu and what was going on and how we might be able to push that particular forward. one of the things he raised in his comments that i thought was very interesting, he said they've already done phase one human trials.

they don't plan to do phase two until the third quarter of 2018 because obviously you want the flu to be out there to a certain extent in order to be able to test it. and he said, you know, i don't -- and i'm going to quote. i do not understand why the fda and cdc do not push a vaccine like this ahead. it would seem to me they might push for phase two in australia this year and possibly a phase three this year in the u.s. that could make the vaccine available for flu season starting in the fall of 2019. if the government is really serious about speeding up the slow approval process and reducing health costs, a process like this would help to do it. and i ask the question because it makes some sense. why aren't we using the australian flu season to start testing some of these new ideas? you've indicated there may be 20 or 30 or 40 new products out there. wouldn't we be able to shorten

that time period, particularly in live trials, if we did some of it here and some of it there where they have the opposite seasons and a different flu season as well. i'll welcome anybody's comments. >> just briefly, congressman, i'm not sure i'm familiar with the product. i think this is a vaccine you're referring to. >> i believe that it is, too. i'm not well enough versed in it to say. tested mostly, i think, comparing it to the vaccine for senior adults. but since i'm apparently rapidly approaching that category, very interested. i turn 60 later this month. >> i'll just say, you know, it is not uncommon to see products tested in the southern hemisphere. i'm not sure what the particular circumstance here is. that is a common te no, ma'phenh new products. you'll see them tested there. >> so i can tell pastor jones y'all are not against it. >> you could pass on to anyone that we are willing to actively engage with any sponsor that's developing a product in this

space. >> it's not a testing in australia versus here. the product that your constituent was referring to is the nano particle that's gone into phase one, the one i showed you the model of. the reason it's not going to go into phase two from the standpoint of until the end of the year is really a production capability. it's what dr. gottlieb referred to what he said what we haven't got efficient yet is the yield of this. so we don't have enough gmp product to start a phase two until the end of 2018. it's not that the fda is holding us up or anything. it's just that we don't have enough product. >> well, i really appreciate that. dr. bright, did you want to weigh in? >> this is very typical. when you develop any new vaccine, it's difficult and takes time. when you develop an influenza vaccine, you have to time it with an outbreak of influenza. as long as it's under a u.s. ind, we are very flexible in allowing the companies to get the data and conduct clinical

studies wherever flu might be in the world as long as it's following that ind process. >> well, that's great. i appreciate y'all helping me answer that question, and i know that mr. jones, who i spoke with yesterday, made sure i could say his name in public. he'll be pleased to hear that as well. let me ask this because the chairman brought it up, and if y'all can get to it briefly. the domestic supply and the threat of maybe having our supply mostly offshore of our flu vaccines. doesn't matter to me who wants to respond to that. >> we work very hard. it's a very important question. we work very hard over the last years and invested great sums of money to make sure we can develop these vaccines and get them licensed. it's critical we expand that domestic manufacturing can papa so they're available when we need them in a pandemic. we cannot import vaccines from other countries easily.

so the domestic manufacturing capability is absolutely critical to our national security. >> and i appreciate that. my time is just about up, but i would say, could you please let us know what we can do to assist in trying to get more onshore production. and i yield back. >> gentleman yields back. chair now recognizes the gentlewoman from florida, miss caster, for five minutes. >> thank you, mr. chairman. thank you to all the witnesses for being here and everything you do to help keep americans healthy and safe. we're now exiting peak flu season, but we're entering allergy season. what i've learned over the past decade is that our allergy seasons are longer and more intense. we have hotter days. back home in florida, the pollen is already raging. what advice do you give to families with children and others in vulnerable populations that are on alert because of the intensity of the flu season as

they begin to deal with allergies. when is the appropriate time to head right to the doctor's office and get checked out if you have a flu? is it the onset of fever? >> if the question you're asking, if the overlap between the two and how do you know which one it is, well, the recommendations we get from the cdc, what we say is that if you have symptoms that persist, number one, that's certainly something you want to go to a physician for. if you have a situation where you look like you're recovering and then you have a relapse, it could possibly be a bacterial infection. but importantly, if you fall into one of the risk categories, elderly, underlying disease like heart disease, chronic lung disease, obesity, pregnancy, child from birth to 4 years old, you should not hesitate to see a physician because that's the group that really would benefit

from getting an anti-viral drug like tamiflu. that's the reason why the cdc recommends we do that. >> yeah, and i would just say that even though we're pleased that the peak of the season seems to have passed, there's still a lot of flu out there. the "b" strains are more common right now than they were a few weeks ago. so we certainly look for fever with flu or flu-like illness. but as described, the warning signs, things like getting better and getting worse is a warning sign, difficulty breathing, a high, persistent fever. for children, not being responsive or hard to wake up. those are really important things. >> i continue to hear the refrain from folks that don't get a flu shot, that they don't get it because last time they got it, it made them sick. that's the reason they don't get the flu shot. what do you say to them? >> yeah, the influenza vaccines don't cause flu.

there can be some feeling of not being that -- not feeling that well, but in general, we give flu vaccines during a season where there's a lot of other stuff out there. so those symptoms are rarely related to the vaccine itself. >> we had a season this year because before we had the peak of flu, there was a lot of para influenza and respiratory virus among adults we were seeing, at least at our clinical center at the nih. that was before the onset of the flu. people were saying, well, i already got the flu, therefore, i don't need a vaccine. well, they're wrong on two accounts. one, because they likely did not have the flu. they had something else. even if you have the flu, you should still get a vaccine because there are other components in the vaccine that could protect you against the other flu that's circulating besides just h3n2. >> and if i might add, this is an area for innovation that is just screaming out to give patients more information, more knowledge about what they might be exposed to in their home. it's one of the reasons we're trying to drive diagnostics out

of centralized laboratories into the home, to the patient so they have actionable information to be able to distinguish that they have a bacterial infection or a viral infection or flu or some other areas. they can take responsible action to get treated sooner and take actions to reduce the spread of that virus. >> thank you. preliminary estimates are that this year's flu vaccine shows 36% effectiveness. i want to hear more about how we assess vaccine effectiveness to better understand this measure. what does it mean that the vaccine is 36% effective, and is it true that this effectiveness was different for different age groups? >> yes, we have a multistate, multisite network that tests vaccine effectiveness. they evaluate people who come in with symptoms consistent with influenza, do laboratory testing of them. those who have confirmed laboratory proven influenza are

enrolled as cases. those who have those symptoms but didn't have laboratory confirmed influenza are enrolled as controls. we compare vaccination history, verified with the records in them, and do sort of math to calculate what the vaccine effectiveness is against particular types and particular age groups. the larger the sample, the more we can look at ages in narrow categories and look at the different types. we do interim estimates? january, february each year and end of season estimates. if we had a larger sample -- a larger network, we would be able to more reliably look at the gem groups but also look at different types of vaccine. >> and i guess your overriding message is no matter what percentage you come up with, it benefits you and your neighbors

and your family to get your flu shot. >> the flu vaccine is the best way to protect yourself and your family against influenza. and some protection is better than no protection. >> thank you very much. >> gentlewoman yields back. chair now recognizes the gentleman from texas, dr. burgess, for five minutes. men >> thank you, mr. chairman. while we're on the commercial to get your flu shot. i want to thank the doctor for telling me to get the flu shot in december. i did, and i didn't get the flu this year. it has been a tough year back in texas. dr. bright, you said there had not been a new anti-viral introduced in the last 20 years. i did understand that correctly? >> that is true. well, 1999 wi. >> so let me -- well, why is this so difficult? i mean, a virus is a pretty

simple organism. nowhere near as sophisticated as a mammalian cell. it seems like that should be pretty straight forward. >> it seems that way, but -- and you're right. there are targets in the replication cycle. the interesting thing is that even though we're doing the fundamental basic research to examine that, we have not had an overwhelming amount of interest on the part of companies, which is the reason why barda has been so important in helping to chaperon the companies along to get involved in this. it isn't a completely insurmountable scientific problem. it has a replication cycle. remember, when we put all of that effort into looking at the various aspects, there were a

total of 30 effective drugs. there's no reason that with the right scientific and interest in it, we couldn't do the same thing. i yield to my colleagues to the left to amplify that. >> dr. gottlieb, i assume on the regulatory side, that's something prepared to take up. >> absolutely. there's a lot of interest in seeing differentiated products put forward that could address the flu for a whole host of reasons, not least of which is the strategic rationale of having that available. the standards for approval are relatively straightforward. i think the agency would show a lot of interest to products that were put forward to try to address both pandemic flu as well as the seasonal flu. there have been safety issues associated with products that have been in early stages of development in the past. but one of the bigger challenges, quite frankly, and this is a little bit outside my remit, but they have been commercial challenges, just the ability to get a commercial

return on a product targeted to seasonal flu. i will remind the committee that at the time that the agency approved tamiflu, the agency was roundly criticized by many outside groups. not by congress, but by outside groups, for that approval who commented that a drug that diminished flu symptoms by 1.42 days isn't something the agency ought to be approving. our mind set has changed around this, but in some quarters not entirely. >> that's an incredibly important point. i was in practice at that time. that did temper your judgment about writing this prescription regardless of cost. if it's really only marginally effective, why put someone through the potential side effects that possibly would occur. dr. bright, you provide the market. it's not ready available, to it's hard to send companies to

take these challenges on. but you provide the market. you're going to be the bulk purchaser of this stuff. >> in the marketplace for anti-virals for a season flu is the marketplace. i don't think there's full appreciation and recognition of the impact and benefit that one can receive from getting an anti-viral drug in a timely manner when they're infected with influenza. we had a new anti-viral, same class as tamiflu. there's still very little uptake. it's a single dose, iv administered drug. so there is hesitancy in the market place to develop new anti-viral drugs, even with benefits and reducing viral load and saving -- reducing the severity of the illness. if the marketplace and the patients in the health care system don't understand and appreciate the power of that drug. >> let me ask you a related question. you talked about bringing down the viral load. kind of encountered when ebola

was causing all of the problems. the rapid reduction of the viral load caused a reaction in some patients. that caused some concern. does that -- is that something a phenomenon with which you are concerned with these types of medications. >> we haven't seen that with influenza anti-viral drugs. we believe it'll lead to less transmission. we believe it'll lead to less severe illness. >> and in ebola, that was more of a -- as opposed to what you see with influn zarenza, with al reaction in the lung. >> very good. thank you. >> gentleman yields back. the chair will recognize the gentleman from new york for five minutes. >> thank you, mr. chair. welcome to our panelists. data from the national immunization survey found that fewer than half of children and adults were vaccinated by november of this current flu season. only about 40% of people 6

months and older received the flu vaccine. these numbers appear to be just about what they were in the last couple of flu seasons. and just interested in hearing from this panel about why you believe these numbers continue to be in that realm and just how do you approach that as an organization. the data show that nearly 60% of americans did not take advantage of that flu vaccination. is that an accurate number? >> you know, the numbers that you're citing are from november. those are our early results. by the end of the season, what we've seen the last several years is that about 48% of americans get the flu vaccine. much higher in children, about 59%, and 43% or so in adults. there's a lot of mixed messages. the thing with influenza, when we have a year like this where it's so severe, everybody

actually knows how bad it can be, but then there's also questions about whether the vaccine is helpful or not. it's really important for the clinicians and for us in public health to remind people that the vaccine has provided protection, particularly in children, and that getting the vaccine each year is worthwhile. >> and what have -- what has your organization been doing to improve the rate, if anything? >> right. we do quite a bit of research on communication. we've done, i think, more than 30 studies to test messages over the past 18 years to try to understand what motivates individuals as well as what influences clinicians in giving a strong recommendation. one of the biggest factors for patients is a strong recommendation from their doctor. we've seen an increase in ob/gyns recommending the vaccine

and more pregnant women getting the flu vaccine each year after they saw how severe it was in 2009 when you were pregnant and got influenza. we've probably hit a wall right now. after this season, there's a lot of concern that we don't know how the community is going to react. we're out there doing research right now and testing messages for next fall. we do use multiple channels in doing communication about vaccine, both traditional channels and social media, trying to find. influencers and address the myths people have. >> and dr. gottlieb? >> i think the cdc has the most robust platform for communicating, but we not only echo the cdc recommendations and their statements but put out a number of our own to try to build on that. i think one of the things we did this season in particular is try to be very transparent about what we were learning about the vaccine effectiveness as we learned it to continue to remind providers in particular and

consumers that this vaccine still had efficacy and had efficacy in particular against h1n1. there was still a lot of value in getting vaccinated because later in the season, you tend to see an upswing in h1n1. >> and in terms of the 100% number, that obviously is something that sounds like you shoot for. how important is it to reach that? >> with vaccines, there's direct protection but also indirect protection. a tat a certain level, the highr proportion of the population vaccinated, they may be helping others not get sick. in particular, i think the pediatric vaccination is important for the children. it's also important for the adults that often get flu from their kids or grandkids.

>> representative caster touched on this a bit. this season we saw many news reports focused on the fact that the vaccine was only 36% effective. in addition, some inaccurate and misleading social media posts have warned people against vaccinating themselves or their children. does cdc have any way of track how these media sources impact the number of people who are actually vaccinated? >> we do assess attitudes periodically and try to understand whether there are rumors that are raze nating or not. when we do research on why didn't you get vaccinated for influenza, we hear more often about, well, i hear that's not an effective vaccine, rather than concerns about safety or concerns about cost. but i think that it varies for each vaccine what the concerns are. we work hard through our

messaging but also through partners and others to get the word out. sometimes the faith-based community can reach a lot of people. mommy bloggers are influential in some circles. friends and family can be influential. our most critical audience are clinicians and health care providers. doctors, nurses, pharmacists have a lot of influence on people's behavior. >> thank you very much. anyone else that wanted to comment on that? if not, i yield back and thank you, mr. chair. >> the chair now recognizes gentlewoman from indiana, miss brooks, for five minutes. >> thank you, mr. chairman. thank you to all the panelists for being here. thank you for your service. as the panel here may or may not know, we have recently started a bio defense caucus. i would encourage all the members here to consider joining our caucus. this is in a lead up to the hopeful reauthorization. i want to go back a little bit

because during the 21st century cures debate, we did get signed into law the return of contracting of authority to barda. i'm curious, dr. bright. this is something we wanted restored. it was in the original passage when barda was created. it's my understanding there's been some hesitation by the contracting office to move the contracting back over to barda. has that yet been properly restored to you since it was authorized and passed into law? >> thank you for the question. we're so grateful for 21st century cures. it's critically important. it has not been finalized yet, but it's important to know it is part of an overall realignment of the entire organization. we look forward to the full implementation of that very soon. >> and what is the holdup? >> the holdup is the alignment with the overall realignment.

so we're in full alignment to implement this as quickly as possible. we anticipate it will be done in a matter of months. >> okay. we'll continue to ask questions until we hear that what was authorized in the 21st century cures has been implemented. i do have a question, though, in the original. it's my understanding that barda was also given other transaction authority to reduce regulatory burden on the federal contracting process that could both inhibit innovation and preparedness. is barda able to use that authority in the original bill? >> barda has been using other transactional authorities. we have six of those in place with different entities. the process of getting the other transactional authorities is still a process that's going to outside senior procurement executives that were working on improving the effectiveness and

efficiency of that process. but we are finding ways to utilize that other transactional authority effectively. >> okay. thank you. sorry you're on the hot seat today. however, with the reauthorization coming, due to expire in september, talk to me about the administration's fiscal year 2019 request of $250 million for pandemic influenza. can you explain at barda authorization of panflu program barda i assume is beneficial, assuming it is reauthorized. would you agree? >> it's absolutely essential, yes. >> can you share with us how those funds would be yeezused? >> i've described a lot of work we've done already. those funds are all obligated. we've made great strides with our industry partners to make our country better prepared for pandemic influenza. there's a lot of work still to

be done. as i said, we need to expand the access and availability of the vaccines we created so they're useful and available for all ages. we still need to develop additional anti-viral drugs. we need more drugs, more treatment options to treat people who are severely ill and hospitalized with influenza. and we need to do a better job with our diagnostics as well. we need to make sure the diagnostics are in the hands of people who need them so they can get treated sooner. all of that work is yet to be done. in the context of still sustaining what we've built, we have to sustain the infrastructure. that is our response capability for pandemic in our nation. in the context of sustaining and filling the gaps, that's how we would support and use those funds. >> and can you talk about the importance of sustained and robust funding, sustained being the critical word here and why

is that so critically important. >> the sustainment of the funding because we rely on these facility and companies to be available and producing a vaccine so when we need it and need it quickly, they have the staff and capabilities in place and the fda is able to continue reviewing and approving that facility. it's important that we don't let our eye off the ball for sustainment. if the factories close, we have no response. we've gained nothing. at the same time, we must sustain our momentum in conducting and supporting the phase two and phase three clinical studies for additional technologies for vaccines, for the platform based technologies in a regional manufacturing process across our country so we can rely on those quickly when we need them for pandemic. >> thank you. i yield back. >> the chair will now recognize the gentlewoman from california, miss walters, for five minutes p. >> thank you, mr. chairman.

california was hit particularly hard this year by the flu season. in my home of orange county, especially suffered with well over twice the number of flu cases compared to last year. orange county had at least a dozen influenza related deaths in individuals under the age of 65. yet, we all know that seniors are particularly susceptible to the flu. the cdc states that at least 75% of flu-related deaths occur in people 65 and older. my district is home to a large retirement population. so i'm especially concerned about the health of this group during flu season. while the overall flu vaccine effectiveness rate for this year is 36%, the effectiveness rate can vary depending on age group. for instance, last year the overall effectiveness rate was 40%, and the effectiveness rate for seniors was only 25%. one would suspect the vaccine effectiveness rate is lower for vulnerable populations like

seniors, but i noticed the 2016-2017 vaccine effectiveness rate was much more effective for children and other vulnerable population. some of my colleagues have asked what accounts for the variability in flu vaccine effectiveness among age groups. what can be done to improve vaccine effectiveness for seniors? >> i can begin. there have been efforts to develop different influenza vaccine products, particularly for seniors and others with weaker immune systems. one such approach is a high dose product that's been licensed. another approach is -- a key strategy that we have at cdc is to make sure patients and clinicians know that people at high risk for complications, including seniors, get promptly treated with anti-virals if they get sick. but the immune system does age, and we think that the frailer elderly have a poor response to many vaccines, including flu.

>> whenever we have a situation, for example, when we are making a vaccine for a possible pandemic, we always test it not only in healthy adults but we also test it in the elderly to make sure the dose and regiment that we have gives a comparable response that a younger person would have. so that's part of the testing. as said, the two major areas of the higher dose, which is recommended for seniors. it's a much higher dose than the dose you give to a healthy young person, as well as using a product that's not a vaccine but boosts the response to the vaccine. >> if i could add, too, this is a lesson from pan deck demic va development. we know in a pandemic vaccine we have to have higher doses of antigen to make them effective across all age groups. i recently in the last two weeks

visited the senior leadership of each of the licensed influenza vaccine manufacturers for the united states and talked to them about this challenge, about what their thoughts and strategies are and how we can improve the effectiveness of our existing vaccines while we wait for the universal flu vaccine. each is poised and strategic and thinking about ways to increase the dose of their vaccine. they're all partnered and interested in utilizing cell based vaccines as well to try to improve the effectiveness over the egg-based vaccines. >> i'll comment very briefly. we're actively looking at data as to the relative effectiveness of the vaccine with the mf-59 and the high-dose vaccine in elderly patients relative to the normal vaccine, the regular dose vaccine with the 15 micrograms of antigen. and i think if we do observe differences between the high-dose vaccine, the efficacy

of the high-dose vaccine or the vaccine relative to the regular season flu vaccine, it could offer some clues as to why the vaccine overall was less effective against h3n2. we'll have that day today available hopefully shortly. we're working closely with cms to drive those results and make it available as soon as we have it. >> okay. and in 2009, the fda approved a high-dose version of the flu vaccine for elderly individuals. there's a study that indicates the high-dose vaccine was 24.2% more effective in preventing the flu in adults age 65 and older as compared to the standard dose vaccine. can you elaborate on whether the high-dose vaccine would significantly reduce flu-related deaths among seniors? >> even a 20-some-percent superior response is still not, you know, 100% because of the weaker immune response that seniors get.

we have -- the market of the higher dose product has been increasing since it was -- became available. cdc doesn't recommend a preference for the high dose over the regular dose vaccine. one of the things we found is that the vaccine that they have at the doctor's office or the pharmacy is the one that you should get because there may not be the other product if you're looking for it. but i think the additional studies that fda is doing with cma and we've done with cms in the past has helped us build this evidence base of what's the best way to protect seniors. >> okay. thank you. i'm out of time. thank you. >> gentlewoman yields back. the chair will now recognize the gentleman from texas, mr. green, for five minutes. >> thank you, mr. chairman. thank you, ranking member, for allowing me to be here. i want to thank the chair for holding this hearing on the current flu season. the 2017, '18 flu season has been one of the worst in recent years, resulting in tens of

thousands of hospitalizations and likely thousands of flu-related deaths around the country. there has been some advances in both vaccine technology and anti-viral drugs which hopefully can both reduce the number of people who get the flu and help those who do get it to recover more quickly. i understand there's a new vaccine production method based on protein technology that makes it less likely for a vaccine to mutate as it is being grown. dr. bright, i have supported the development of several vaccines based on this technology as well as the development of cell-based vaccines and antigen sparing vaccines. can you explain why barda has chosen to support research on these vaccine production methods rather than the egg-based production methods. >> we primarily focus on supporting those new, modern technologies to be able to respond faster and more

effectively to a pandemic response. we know that you can cut out steps necessary to make a vaccine in the egg. you don't need a virus to grow -- to produce vaccines. you can start from a gene sequence and rapidly go into production of your vaccine. this affords us great flexibility and great speed compared to egg-based vaccines. we're learning now that investments in those new technologies might also offer advantages of a potentially more effective flu vaccine. what's critical to know about this, too, is it's one thing to license those vaccines and make them available, but if they're not available in sufficient supply and don't have the capacity to produce it, then they are not penetrating the marketplace, and those companies are frail and vulnerable, at risk of going out of business after huge investment if that vaccine is not used. >> thank you. commissioner gottlieb, preliminary data suggests that some of the newer vaccines, is

up as high-dose vaccines, may offer greater protection. is there enough data on these vaccines for the fda to recommend these vaccines over others? if not, what type of data would the fda need to make such a recommendation? >> congressman, we're still evaluating some of the data relative to the high-dose vaccine and the vaccine to see its relative effectiveness. we start to speculate around why the vaccine has been less efficacious, one of the theories you would put on a table is certainly perhaps you might require a higher dose of antigen in order to have an adequate immune response against h3n2. so it's something we're going to need to consider among many other possibilities on why historically we haven't seen a robust immune response from the -- against h3n2 from

vaccines generally. the one thing we did observe so far this season was that the vaccine produced in cells, the cell-based vaccines, we had about 20 million doses produced in cells this year, those do appear to be -- to have provided more protection on a relative basis of around 20% than the egg-based vaccines. again, we aren't sure of the reasons why, but it does lead to some hypotheses around why maybe generally speaking we haven't seen as robust a response against h3n2 historically as we'd like. >> i know there are a number of new anti-virals in the pipeline, including some that may treat the virus at the beginning of the life cycle. 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. >> absolutely. i think that's important to recognize. one class of drug that we have that's effective on the market today is an inhibitor. it binds to an active pocket of

a surface protein of the virus and really blocks the virus after it's already replicated from breaking away from an infected cell and going on to infect other cells. these new anti-viral drugs are working on the replication cycle of the virus before it reproduces itself and buds away. it's because they work in a different part of the virus life cycle. they also can be effective if the virus mutates and becomes resistant to the single class of drug we have available on the market today. so it's critical we have these different approaches to anti-viral drugs. >> thank you. mr. chairman, i know i'm out of time. i have some other questions i'd like to submit if it's allowed. and thank our panel for being here today. we're looking for that light at the end of the tunnel. i just appreciate each of y'all partnering with each other to deal with it. obviously flu is terrible, but there's a lot of other bugs out there we'd like to deal with too.

thank you, mr. chairman. >> gentleman yields back. i will remind members they have ten business days to submit questions for the record. i ask the witnesses to read or respond promptly should you get additional questions in writing. i want to thank you for your time being here today. it's very informative. i enjoyed the slide presentation. i felt like i should get some college credit for that, to see that. to visualize that and see how it's better to attack the stem instead of the head and actually give you a good visual was very informative. you know, one day we'll be in here and be discussing that effective universal flu vaccine that we know we all desire to see. i was going to say i hope we continue to take steps, even if they're nanoparticle steps, to get to that conclusion. but again, thanks, each of you, for being here. the subcommittee hearing is adjourned.

more live coverage on c-span networks later today. at 2:15 eastern, a senate armed services subcommittee will hold a hearing on domestic violence

and child abuse in the military. live coverage starts a the 2:15 eastern here on c-span3, also online at c-span.org. later today, former national security adviser susan rice will discuss global security. live coverage begins at 4:30 p.m. eastern on c-span. and christine lagarde, the managing director of the international monetary fund, marks international women's day with an interview with "the washington post" reporter. you can see that at 6:00 p.m. eastern, also on c-span. monday on c-span's landmark cases, we'll explore the 1886 case where a san francisco city ordinance discriminated against a chinese laundromat owner. the anonymous ruling, written by stanley matthews, found in favor of the laundromat owner and established equal protection under the 14th amendment applies to immigrants as well as

citizens. examine this case with mae ngai, professor of asian-american studies at columbia university and author of "the lucky ones." and josh blackman, associate law professor at the south texas college of law in houston and founder and president of the harlan institute. watch landmark cases live monday at 9:00 eastern on c-span, c-span.org, or listen with the free c-span radio app. for background on each case while you watch, order your copy of the landmark cases companion book. it's available for 8.95 plus shipping and handling at c-span.org/landmarkcases. and for an additional resource, there's a link on our website to the national constitution center's interactive constitution. in this year's student cam competition, we asked students to choose a provision of the u.s. constitution and create a video illustrating why it's

important. students competed for the chance to win cash prizes, and we received 2,985 entries from 46 states. the first prize winner for the high school east category goes to hemakshi gordy and jansilkwe from maryland. the first prize winners of our high school central category are will foote and james dyer from white fish bay high school in whitefish bay, wisconsin, for wisconsin votes count. our student cam first prize winner for the high school west goes to may zhen and payton liquin from capital high school in boise, idaho, from prison reform. our middle school east category winners are from eastern middle school in silver spring, maryland, for survival of the veiled face, the constitutionality of abortion.

our judge's special citation for creativity goes to these students from sozo missions in bradenton, florida, for their documentary "be true to the constitution." and finally, we're happy to announce our grand prize winners. adam koch and tyler cooney from dallas center grimes high school in grimes, iowa, for their documentary "old enough to fight, old enough to vote." >> we're seeing 2,985 videos from almost 6,000 students. we're just calling to let you know you won the grand prize. >> yeah! >> yes! >> you know, with this year's topic, it was just such an open-ended question. we really had some time to focus in. when i looked online and got the contact information for the person who authored the

amendment, i thought, tyler, we have to do this. we have to get in contact with this person. so we sent some e-mails, started filming, we sent even more e-mails after that, and everything kind of fell into place. >> the process for picking the amendment was pretty difficult. 26 different amendments we kind of looked at, evaluated. there's lots of controversy going on right now in the public. so we kind of sat down and found something that related to us at our age and what really affected us is we're heading into college next year. the 26th amendment, we were able to get in contact with some important people here in iowa and around the country. it really clicked for us. we got working as soon as we could. >> the top 22 winning entries will air on c-span in april, and you can watch every student cam documentary online at studentcam.org. up next, public policy and its impact on race relations in the u.s.