they talked about efforts to create a universal vaccine, assessing the effectiveness of vaccines, and dispelling myths about vaccination. this is one hour and 40 minutes. . >> good morning. this year, like so many previous years, we've had a bad flu season. after months of 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 certainly 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 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

.lu vaccinations even though only a little over half of americans typically get vaccinated, cdc estimates that flu vaccination prevented 3000 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, h3n2. the vaccines reduced effectiveness against h3n2 is especially concerning. historically we have struggled to make an effective vaccine against h3n2. for example, during 2014/2015 flu season, this committee checked the vaccine's effectiveness due to the mismatch between the strain used

and theop the vaccine h3n2 strain that was actually circulating. the flu that scene only 9% effective during the -- season. ofs experience reminded us the importance of being able to rapidly detect and respond to changes in the challenging and circulating flu viruses. 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 an 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. i appreciate the hard work and dedication of the people at hhs to improve our flu preparedness, including those at cdc, nih, aspr and fha. one of our top priorities is to keep americans healthy during

flu season and improve the federal and public response. i look forward to today's testimony. the chair will recognize ranking for purposing 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. i 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'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 of flu 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 this year, with nearly 4000 people hospitalized due to flu and 160 flu outbreaks in long-term care facilities. as the chairman mentioned, 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, or 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. and so, i think that this year, if it's any good news, 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. and i know all of our witnesses will remind us -- even a vaccine with a low effectiveness rate will still prevent people from getting sick, or help mitigate symptoms when people do get sick. and so until we fix this 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 that's another thing we can discuss, about how we can persuade people to get the vaccine and concrete steps that perhaps 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 done, 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 here 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. oh, 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 now 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 flu vaccine mismatches.

for more than 70 years most have been made through an egg-based process and over the last decade 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 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 i understand 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 2009, the fda approved 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 and information to make sure we're make the most effective seasonal flu vaccine possible. the fda recently announced that preliminary data shows cell-based flu vaccine might be more effective i understand 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 improve vaccine 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 people get that vaccine. and so if you do get the flu, there are anti-virals. i can't remember a flu 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 apparently might cut off the flu even sooner and what you see on that one, if anything. and one day we hope to have a universal vaccine. we are encouraged by a recent release of a strategic plan for developing a universal flu vaccine. we have all of you here today to share the information that you all are working on. so thank you. with that i yield the remainder of my time to the chairman of the health subcommittee, the good doctor from texas. >> thank you, mr. chairman, and 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 districts with astonishing force this year. the district that i represent in north texas, our public health departments were strained, we had schools that had to close temporarily to prevent the spread of flu amongst children. e

spread of flu amongst children. since the start of this flu 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. earlier this year the health abcommittee was briefed by doctor from the cdc about the development and effectiveness of this year's flu vaccine. 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 and 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. and 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 centers 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 that 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, in that case if you would please rise, raise your right hand and i will swear you in. do you swear that 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 now 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 often able to outsmart our immune systems. we've worked -- systems. at cdc we have worked to build cutting-edge systems to -- 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've made, we have much more work to do. i will provide brief updates this season and the work to cdc is doing to improve the tools for influenza prevention and control. as you have heard, this has been a severe season. hospitalizations have broken records.

influenza-like illnesses in doctor's offices and emergency rooms was 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 some of 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% overall, and even lower for the h3n2 strains that dominated. children did receive better protection from the flu vaccine. 59% effectiveness in children and 50% effectiveness against the h3n2 strain, 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 that there are egg-adapted changes that occur in the processes of developing the vaccine. there may be differences in effectiveness based on prior immunization or prior exposure 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 maximize use of the current vaccines, we want to support the nih's leadership in developing a universal vaccine , and in the near term 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 insurers 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 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 to get vaccinated. 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, h7n9. next slide. we need to improve on the current influenza vaccines. 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 also 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 improving seasonal influenza preparedness, that essentially marries you to preparing for a pandemic. and i will tell you what i mean.

next slide. 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. now, let me talk to you a little bit about that. because there are some 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, hemagglutinin molecule which is the part that binds to the cell receptor that gets you and i sick when we get the flu. next slide. now, a very interesting thing was noticed several years ago. this made up the molecule of a head and a stem. this is what it really looks like, but if you want to emphasize this, think of a broccoli with a head and a stalk or a mushroom with a cap and

a stalk. the head is the part that the immune system makes respond again. that's the good news. the bad news is that 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 mutations. so the trick is how do you make a response selectively against the part of the virus that does not change as opposed to one that does 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 10 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. and 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 goal i've just been describing over the last five minutes. thank you. >> thank you very much 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 today on behalf of our assistant secretary for preparedness response, the aspr. to discuss the availability of effective flu vaccines. i'm rick bright, the director of the bio medical advanced research development and authority, known as barda. also the deputy assistant secretary for preparedness response. aspr's mission is to save lives and protect americans from 21st century threats. barda is a component of aspr that it was created 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. cupave achieved 34 approval's from the fda for drugs, vaccines, and diagnostics against a wide range of threats. we have increased the influenza vaccine capacity by 10 fold. we have shortened the response time with modern technologies and we have never supplied vaccine production -- we have diversified vaccine production outflows. successan rival barda's

in pushing new products to the marketplace. we are proud of the new flu vaccines. firstinclude the world's flu vaccine and the largest vaccine production facility. we are not done yet. everything that barda and our partners have done can make our seasonal influenza vaccines better. and more responsible -- responsive to the ever-changing virus. we are poised and partnered to make better vaccines available now. most vaccines today are still made in angst. although the process is optimized for efficiency, it does not change much per decade and is no match for a rapidly changing virus. cell-based technologies are used to make license-based vaccines and they offer speed and flexibility and may be more

effective than traditional a-based vaccines. come upthese 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 dramatic near-term in parallel with long-term efforts being undertaken across the government to develop a universal flu vaccine. to make better, faster flu takenes now, we propose to the following steps to improve the effectiveness of our vaccines. we must expand domestic capacity of our vaccines. we must enhance the effectiveness with additional higher doses of angevin. we need to conduct clinical trials to expand their use.

finally, we need to modernize the processes for speed and flex ability. while we are grateful for the supplemental funding that disrupted the status quo and fueled our progress, those funds have been fully obligated. to win this battle, it is critical we sustain these hard-won gains and we implement these steps to reduce the threat from influenza. in the near term, activities are only one proceed -- one piece of the puzzle. they can do tech informs us as well as more effective drug treatment options to treat six people. these -- six people. people. together with our industry partners, we have made tremendous progress, but 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 and congressional colleagues. thank you to the opportunity to present to you today. >> thank you very much. the chair recognizes scott godley for his opening statement. >> thank you, mr. chairman. thank you for the invitation to testify on our response to 2017-2018 seasonal flu. this flu season has been particularly hard. investing and working toward a universal flu vaccine is crucial. unfortunately, given where we are in the development process, that reality is many years off. while we should continue to focus on the discovery of a new breakthrough, we must discuss what intermediate steps we should take to enhance the production of existing vaccines and what should be done to advance manufacturing to ensure new technologies are scalable, that manufacturers meet global

demand. there have been successes in , in partd vaccines because of the collaborations and work mby bartha. but the majority of manufacturers are still continuing to produce a-based best scenes -- eggs based vaccines. there are reasons for this. they are safe and effective. changewould manufacturing. we believe it is worth understanding on alternatives. some say they could be more vocations than a debased vaccines, but no more analysis -- but more analysis is needed. we are using cms data to compare for the patients

vaccines to determine which was more effective in that population. as we consider greater investments, it is important to note that there are challenges with these cell-based approaches. to help address these challenges, we are working on different cell lines. we are also looking on how to develop more robust manufacturing process to increase yields. continuous manufacturing holds great progress because supply could be more easily ramped up on short notice. this would allow us to rapidly address strange rift and getting all the necessary repertory work done is one limiting step of the faith-based processes. -- and based -- egg-based proceces.

the tools and guidelines for products to be developed into these systems and improperly a lightweight and ultimately our investment will provide clarity for this technology. that framework will increase the efficiency and reduce costs of transitioning to this new product development manufacturing. more immediately, as we prepare for next flu season, we are trying to understand why this year's vaccine was less effective against h3n2. the data presented continued to forest the strain selected the 2017-2018 strain has been , thismight manufacturers includes the h3n2 strain. although adapting circulating virus strains currently to differences between circulating strains, and although the changes could affect vaccine effectiveness, the case this year is likely to be more complex.

this year is not the first time we have seen vaccines less effective against h3n2. recent vaccines have been proven to be only 33% effective against h3n2 virus is. we are looking at several factors as to why this is. inwe continue to invest technology, we also need to remember the importance of ensuring more people get vaccinated each flu season. we also must work hard to ensure products used to treat the flu, including antivirals, are available and we take steps to address shortages. as always, the fda it remains committed to sharing updates with the public about all aspects of our flu response and i look forward to answering your questions. >> 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 the daily dealing with this important issues, so thank you for this time, this education you are giving us. i will recognize myself to ask the first set of questions. just 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 got an it also? the vaccine every year and make sure my whole family does. >> sin here. i got the vaccine this year and every year since i can remember as has my wife and three children. >> absolutely. >> absolutely, sir. i go to the pediatrician with my children and he gives it to me and to them. >> that's great. if you get the flu after getting

the flu vaccine, is having gotten the flu reduced the severity of the illness? >> there are studies that show reduced severity following immunization even if it is not prevented. >> that is true and that is an important point most people don't appreciate because they say they do get the flu even though they got vaccinated. but what they don't realize that it is possible that having gotten the flu might have wound them up in the hospital, delete someone in the risk groups more prone to getting complication. >> that's right. there is data to support that even if it is not the most effective vaccine, still does a lot to reduce hospitalizations. >> i just echoed their statements. >> great. i have heard some concerns that some individuals are worried they might get the flu from the flu vaccine. is that possible? >> no, the flu vaccine cannot

cause the flu. you say arethings impossible, but this is impossible. >> agreed. >> i agree, as well. >> there are misconceptions out there that with the same group, i want to make sure people realize those important facts going forward. if i may talk to you for a moment, this year we have seen a lot of headlines about the flu vaccine's reduced effectiveness. later we are going to ask questions about reduced effectiveness, but i want to ask about vaccine effectiveness for children. answered the effectiveness of that was 59% effective, much better than adults. it more effective on children than older adults? >> we don't have all the

answers, but there are a couple possible explanations. one is children's immune responses are integrally better -- particularly better than adults. and the response may differ if it is the first time you have been exposed to it. you may have a better response. some people think that the first influence you are ever exposed to through the vaccine or the nature has a long-term effect on your immune response, we were pleased to see the better response in children this year. >> how do we communicate that? why is it important for school-age children to get vaccinated? how do we communicate that and certainly, you would agree that is true? >> we have simplified our recommendations for children and now we recommend everybody six months and over get a vaccine every year. the first time, you are supposed to get two doses of the vaccine.

communication about vaccination has to be multisectoral. providers,alth care pediatricians are the most important influence on kids getting vaccinated, but we also use trusted channels, social media, and other influencers. seen by thebviously flu vaccine has remained steady, just under 60% of the number of adults receiving the vaccine remained steady at 41-43%. had to redo that further not just children, but adults also? message is a nuanced because being open and honest is really important and not promising that the vaccine will cure cancer, although we have a vaccine that does that, actually. sorry. i think americans want us to be open and honest about vaccine information.

we know that flu vaccines can prevent disease and reduce the severity and we know they can also prevent spread. children are important in getting flu disease but also spreading it. so getting higher coverage among children is in the whole public's interest. >> thank you very much. thechair now recognizing ranking member for the purposes of questions. >> thank you, mr. chairman. i think everybody on this panel agrees with you when you said that we need to get away from the antiquated production model, which the egg is. and i know the chairman particularly appreciated your sideshow. he is new to this committee 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. recumbent based vaccine

was only 3% last year from what i understand. i'm wondering if you could talk to me, what the barriers are for moving from the current methods of that we have, the egg-based methods of the majority to this cutting edge of vaccine. i will ask everybody else for their opinion, too. >> i think there were a few barriers that stand out. one was that there were still scientific challenges to get the best republican seat in technology -- recumbent seat in technology and the addition was fluone that was used the block. there were things even better than that. and that was part of what i put the congressman into getting a strategic plan that there were scientific gaps in the arena of

"platform technologies, different types of vaccines. the second one that was important is that whenever you as dr. gabi mentioned, something that is time-honored and works and is safe, there is an understanding, fundamental underlying in her shop -- inertia that accompanies that we will have to make a major investment in resources to switch over from one to another. you have one you know that works and is safe. the thing i think we need to emphasize is that we got to go there. we can't stay stuck in the old technologies. >> thank you. dr. bryce, do you want to add to that? >> i think what he said was spot on. in addition to the capacity and the yields of new technologies, we have had 70 years to optimize the yields.

we have had five years to work on optimization for cell-based vaccines. it's remarkable to see the progress being made in these companies to improve efficiency of production and the yields of those vaccines. vaccinechallenge is the blends together the marketplace, so there has to be a focus on getting the differentiated data set to show effectiveness of basedased and non-egg- vaccines are speed and flexibility. those are critical for response if we have to change midseason. we are also getting additional data to understand the true effectiveness difference. >> did you want to add anything? >> i agree with my colleagues. one of the challenges still is the cell culture and the yields you are able to derive using the process.

while we observed better efficacy this year relative to vaccine, we -- the underlying message here is =based process is -- works. >> it's hard if you have a pandemic that hits. did you want to add? >> just to say investments in vaccine effectiveness are really worthwhile. it's only recently we could tell you the effectiveness against h3n2 is less than against the others -- >> so aside from funding, i will , is there you anything else congress can do to move this along? i remember years ago asking the same questions.

i'm glad we made progress, but clearly we have to get to the gold standard. >> if i may quickly comment, as part of the president's budget, we did put forward a proposal to make investments and that was geared toward this kind of opportunity to establish a regulatory parameters to enable these innovations going forward. >> anyone else? >> it does go back to funding and some ways, but just to support and encourage the movement to modernize technology in addition to expanding capacities will me need them. >> i think we can say we have bipartisan capacity for this. thank you, i yield back. >> chair will now recognize chairman of the energy and commerce committee, greg walden, for purposes of questions. >> thank you, mr. chairman. thank you to our distinguished panel of witnesses for the great

work you do every day to improve the lives and health of americans and people around the world. one of the treatments available for individuals who get the flu is the antivirals. we talked some about that today. our antiviral drugs more effective the earlier they are given? >> they are, congressman. >> and how do they work? >> they are currently available and the drug 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. issued aeek, the fda press release warning of unapproved products. why did you feel the press release was necessary to warn consumers to be cautious? >> we have seen a lot of efforts to entice consumers to purchase products we know are

fraudulent and make false and misleading claims. they are not approved for those purposes, including dietary supplements. >> if tumors feel like they have been defrauded, what should they do? >> anticonsumer that feels he might have used the product -- any consumer that feels he might have used the product should contact their medical provider and refer their information to the fda. >> and recently, as i mentioned, a new antiviral drug was approved in japan. it supposedly has potential to treat the flu in one dose. are you familiar with that product and can you talk to us about if that's the case and what we might see here? >> i'm familiar with of the product. i would defer to my colleagues a little bit. what the sponsor has said

publicly is that they plan to submit an application sometime this year and they have disclosed they have studies ongoing in the u.s. looking at a high risk population. this acts at a different point in the replication cycle, earlier stage than the other drunk you referenced, so it is differentiated. the other potential opportunities of onset of action appears to be earlier than the currently available antiviral. is wettom-line message are interested in having a spectrum of antiviral drugs that act differently at different case itn the virus in comes to resisting one approach. we have backups and alternatives approaches. >> other members of the panel want to comment on that? bartha's been engaged with this company as well as other companies supporting to develop drugs for influenza. it is critical to note have not had a class of antivirals

approved in over 20 years. we rely on a single class of influenza viral's now and the virus continues to change in resistance and emerge. it is concerning and aiding influenza viruses, such as pandemic viruses, to see this high level of resistance. it is remarkable this company took the lead in developing a new class of antiviral rug that has attributes of a single dose instead of five days. it brings down the viral load in the patient rapidly, faster than the currently approved drugs. a new mechanism action so if the virus becomes resistant, the only class of drugs we have now, this drug would still work. incan also be used combination with the existing class of drugs. the other thing exciting is that they partnered with a u.s. based company. that company took 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 the drug in the note states in the near term. it is one of about a dozen or half dozen promising candidates with new mechanisms of actions, several supported by bartha to make better treatments for flu. >> i can't help myself on this, mr. chairman, for the benefit of chairman hopper. this washt said that extraordinary 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 of sciences funded by the national institute of health. --is entitled

thatst 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. >> that's good. that's part of why we did 21st century -- to continue funding. i was hoping to ask questioning threats andes and opportunity, but my time has expired. maybe we can get some of that if the hearing continues. thank you again for your good work. >> chair will now recognize general waldman from illinois for five minutes. >> i want to thank you 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. i have some basic questions,

just as an ordinary consumer and person. you might be the person to ask. can you tell us how easy it is to spread the flu virus person-to-person? by strain, but of course this is one of the more effectives -- infectious viruses we have. in a household, spread is frequent, in a school, spread is frequent. it can be spread through respiratory droplets. they say cover your nose when you cough or sneeze and don't touch your eyes or mouth after -- 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 trying for-48 hours

after the fever goes down. byh influenza, it varies year, but those are general facts. >> 24-48 hours after the fever? >> after the fever goes down. >> the cdc recommends people stay home for 24 hours after their fever breaks. point out,d to according to the bureau of labor statistics, 28 percent of workers have no access to paid sick leave and this is particularly a problem for those in the lower income, low-wage jobs. one third of lower paid workers, including those who works in food preparation, have no paid sick leave. in fact, the united states is the only industrialized country can youpaid sick leave, explain why this is important for people to stay home when they are sick? >> we are trying to limit the

spread of the virus so staying home while you are sick will help you heal and keep you from spreading to others. so in 2016, the national bureau of economic research found 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 are sick, people are less likely to get the flu. i know this is not your jurisdiction, but i think it is just important to note that some of the cautions that 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 is a public health issue. paid sick leave is a public health issue. i wanted to also note that

holland,what it, heather holland in texas, a texas mother died because she could not afford the co-pay for tamiflu, which was $116. and she had insurance. so this was a co-pay. first of all, tamiflu, what 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 some one comment on that? >> i can just say that in response to the shortage of antiviral medicines this year, we work closely with manufacturers and pharmacies and insurers and we learned that there were plenty of supply, but much of what was available was brand product rather than newer

generics. we did get some agreement by pharmacies or pharmacy benefit managers and insurers to offer the generic at her for brand or -- sorry, to offer the brand as generic or preferred brand, which would give a lower co-pay. but that's a very sad story. we don't know antivirals will cure a person. the best data suggest they shorten the illness and being able to >> in conclusion, let me say that paid the leave and affordable pharmaceuticals are very important issues that we need to grapple with. -- thank you. the chair will not recognize the jim demint from virginia for five minutes. has been very informative.

i appreciate all the testimony. you are doing great things. on february 28, week or so ago, i got an even from a constituent who keeps up with these issues. he started talking in his email -flu and how we might be able to push the product forward. one thing he raised, they said they are ready did phase one. they have already done phase one human trials. plan to do phase two until the third quarter of 2018 because they want the flu to be out there to a certain extent to test it. i am going to quote from his email "i do not understand why this -- they do not push a vaccine like this. it would seem to me they might

push for a 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 in 2019. if the government is serious about reducing health costs, a process like this would help." why are we using the australian flu season to start testing some of these new ideas? you have indicated there might be 20 to 40 new products out there. wouldn't we be able to shorten that period if we did some of it here and some of it there? i will start with you. i welcome anybody's comments. >> i'm not familiar with the product. this is a vaccine you are referring to? >> yes. it has been tested comparing it

to the vaccine for senior adults. >> i will just say, it is not uncommon to see products tested in the southern hemisphere. i am not sure what the particular circumstance here is. that is a common phenomenon. you will them tested to help accelerate the process. >> so you are not against it. >> we are willing to actively engage with any sponsor. it is not a testing and australia -- in australia versus here. phase one. into the one that i showed you the model of. the reason it will not go into phase two from the standpoint until the end of the year is a projection capability.

what he referred to when we said we have not gotten the yield of this. we do not have enough product to start a phase two until the end of 2018. it is not that the fda is holding us up or anything. we just do not have enough product. >> i really appreciate that. >> when you develop a new that scene, it is difficult to take the time. under a u.s. is imd, we are very flexible wherever the flu might be in the world, as long as it is following the imd process. >> i appreciate you helping me answer that question. i know that mr. jones, who i spoke with yesterday, i'm sure he will be very pleased to hear that as well. the chairman brought this up.

and thestic supply threat of having the supply offshore of our flu vaccine. hard.work very it is an important question. we worked very hard and invest great sums of money to make sure we can develop these vaccines. only are they able to meet a seasonal market demand, they are also available when we need them for a pandemic situation. we know we cannot import maxine's from other countries. the domestic manufacturing are absolutely critical for national security. >> i appreciate that. would you please let us know what we can do to assist in trying to get more offshore production? recognizes thew gentlewoman from florida.

>> thank you to all the witnesses for being here and what you do to help keep america healthy and safe. we are now exiting peak flu season but are entering allergy season. what i have learned is that our allergy season is longer and more intense. in florida, the pollen is already raging. what advice would you give to andlies with children 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 to the doctor's office and get checked out if you have the flu? >> how do you know which one it is? the recommendation that we get from the cdc, i will yield to

the doctor in a second. if you have symptoms that something youis want to go to a physician for. if you have a situation where you look like you are recovering and then you have a relapse, it could be a bacterial infection. if you fall into one of the risk , elderly, underlying disease, chronic disease, , you shouldegnancy not hesitate to see a physician because that is the group that would benefit from getting an antiviral drug like tamiflu. that is why the cdc recommends that we do that. >> even though we are pleased that the peak of the season seems to have passed, there is still a lot of flew out there. strains are more common than they were.

we look for flavor -- we look for fever, but the warning signs for children, not being worse responsive or hard to wake up are really important. >> i continue to hear the a flu shotnot to get because the last time they got it, it made the like. -- made them sick. what do you say to them? >> the influenza vaccine do not cause the flu. there can be some feeling of not feeling well, but in general, we the vaccine when there is a lot of other stuff out there. >> we had a season this year because before the peak of flu season, there was a lot of para ,nfluenza that we were seeing

at least at our clinical center. that was before the onset of the flu. people were saying they arty got the flu so they did not need a vaccine. they probably did not have the flu, they probably had something else. even if you have the flu, you should get a vaccine because there are other components that can protect you against the other flu that is circulating. >> this is an area for innovation. information and more knowledge of what they might have been exposed to in the home is one of the reasons why we are trying to drive diagnostics out of laboratories and into the homes of the patients. they have actual information to distinguish. they can take responsible action to get treated sooner. >> preliminary estimates are showedis year's vaccine

36% effectiveness. --ant to hear how we have better understand this measure? how do we test for vaccine effectiveness question mark what does it need that it was 36% effective? was it different for different age groups? networkve a multi site that tests effectiveness. they evaluate people who come in with symptoms consistent with influenza. the laboratory testing of them, those who have laboratory proven influenza are enrolled as cases. those who have those symptoms but did not have laboratory confirmed influenza are enrolled as controlled. we compare vaccination history, verified with records and do the math to calculate what the effectiveness is against particular types and particular age groups.

the larger the sample, the more in narrowk at ages categories and look at the types. we do into rome estimates in estimatesd -- interim in january and february. if we had a larger network, we can more reliably with the age groups and look at different types of vaccine. >> your overriding message is that no matter what percentage you come up with, a benefits you and your neighbors and family to get your flu shot. >> the flu vaccine is the best way to protect yourself and your family against influenza. some protection is better than no protection. recognizes thew gentleman from texas for five minutes. want to thank dr.

personally because he told me i better get the five shot -- the flu shot. i did not get the flu this year. it has been a tough year in texas. hasbright, you said there not been a new antiviral introduced in the past 20 years. >> that is true. this question is for dr. fauci. why is this so difficult? a virus is a pretty simple organism. toxicitylike suggested , talked about in that paper that you showed us -- it seems like it should be pretty straightforward. >> it seems that way. you are right. there are targets to the replication cycle.

thing, evening though we are doing the fundamental research to examine that, we have not had an overwhelming amount of interest on the part of companies, which -- has been so important in chaperoning the companies to get involved in this. you are right. it is not a completely insurmountable scientific problem. it has a replication cycle. intowe put all that effort looking at the various aspects of the replication cycle of hiv, 30 effectiveth drugs. there is no reason why, with the right industry interest in it, we cannot do the same thing. i yield to my cogley to my left -- to my colleague to my left. i think there is a lot of

interest in seeing differentiated products put forward to address the flu for a host of reasons. the strategic rationale of having that available. arestandards for approval relatively straightforward. i think the agency would show a lot of interest to a product that would address pandemic flu and seasonal flu. one of the bigger challenges, this is a little outside my expertise. the ability to get a commercial return on a product for the seasonal flu. by the time agency approved tamiflu, the agency was criticized by many outside groups. thatcommented that a drug diminished flu symptoms by today's not something the agency

should be approving. our mindset has changed, but in some quarters, not entirely. that didn't temper your judgment about writing this prescription, regardless of cost. effective.marginally possible side effects could occur. you provide the market. companies to incense to take these on. you are going to be the purchaser of this? >> the market place for antivirals is the marketplace. i do not think there is full appreciation or acknowledgment. antiviral, same class as tamiflu, approved by a

company a few years ago. uptake oftill little that new antiviral drug. it is a single dose iv administered drug. even with benefits in reducing viral load and the severity of illness. andhe marketplace, patients health care system does not appreciate the power of that drug. >> let me ask you a related question. when kind of encountered ebola was causing problems. reaction load caused a , which cause concern. is that a phenomenon in which you are concerned with with these types of medications? >> we believe it will lead to less transmission. to lessve it will lead

severe illness. more ofebola, that was a viremia. you would not expect the side effects with that. >> the chair will now recognize the gentleman from new york for five minutes. datalcome to our panelist from the national immunization survey. half of children and adults were vaccinated by november this current flu season. six months and older received a flu vaccine. the numbers appear to be about what they were in the last couple of flu seasons. just interested in hearing from why you believe these numbers continue to be in that realm and how do you approach that as an organization?

shows nearly 50% of americans take advantage of the flu vaccination. is that an accurate number? >> the numbers you are citing are from november. those are from early results. by the end of the season, what we are seeing is about 48% of americans get the flu vaccine. 43% in adults. there are a lot of mixed messages. , whening with influenza we have a year like this when it is so severe everyone knows how bad it can be. there are also questions about whether the vaccine is helpful or not. in public health, we remind people that the vaccine has provided protection for 2 billion children. during the vaccine each year is worthwhile.

-- getting the vaccine each year's worthwhile. >> what has your organization been doing? >> we do quite a bit of research on communication. we have done more than 30 studies over the past 18 years to understand what motivates individuals, as well as what influences transition. a strong recommendation from the doctor, we have seen an increase in ob/gyn's recommending the vaccine. we have probably hit a wall now. after this season, there is a lot of concern that we do not know how the medical community or public will react. we are doing research right now and testing messages for next fall.

we use multiple channels in doing communication about the vaccine, traditional and social media. trying to find answers and address the myths people have. we not only echo the cdc recommendation and their statements, but we put out a number of our own to try to build on that. one of the things we did this season was try to be very transparent about what we're learning about the vaccine. to continue to remind providers in particular and consumers that the sex scenes still had that the vaccine still had efficacy. there was still a lot of value in getting vaccinated because later in the season, you tend to see an upswing in the hln and one -- h1n1 virus.

100%, that number is something you should four. helpful -- how important is it to reach that -- you should four -- you shoot for. how important is it to reach that? >> i think the pediatric vaccination is important to the children and for the adults that often get the flu from their kids or grandkids. this season we saw many news reports focused on the vaccine only being 36% effective. in addition, some social media posts have warned people about vaccinating themselves or their children. does the cdc have any way to track how these sources impact

the number of people who were actually vaccinated? >> we do assess attitudes periodically and try to understand whether there are rumors resonating or not. when we do research on why you did not get vaccinated for that ita, we hear about is not an effective vaccine rather than concerns about safety or cost. each vaccine what the barriers are or what the concerns are. we work hard to government messaging and through partners and others to get the word out. there are mommy bloggers that are influential in some circles are you rinse of family can be influential. audience areical clinicians and health care providers. they have a lot of influence on people's behavior. >> thank you very much.

the chair now recognizes the gentlewoman from indiana. >> thank you mr. chairman and thank you to the panelists for being here. as the panel here may or may not aow, we recently started caucus to encourage all the men -- a caucus. this will lead to the hopeful the authorization of pop up. law.d get signed into the return of contracting authority. i am curious, dr. bright, this was something we wanted restored. it is my understanding that there has been some hesitation by the contracting office to move the contracting act over.

does that contract authority proper restore to you, since it was passed into law? are so grateful for tray for sentry cures. it has been -- 21st century. it is part of an overall realignment in the organization. we look forward to the full implementation of that very soon. >> what is the hold up? -- thealignment with realignment. want to implement this as quickly as possible. we anticipate it will be done in a couple of months. >> we will continue to ask questions until we hear what has been implemented. i do have a question. in the original, it is my understanding that they were

given other transaction authority to reduce regulatory burdens on the federal contracting process that could inhibit innovation and preparedness. are they able to use that other authority that was in the original bill? >> they have been using transactional authorities created -- transactional authorities. still a process of going to outside procurement executive. we are working on improving the effectiveness. we are finding ways to utilize that. sorry you are on the hot seat today. ,ith the reauthorization coming it is due to expire in september. talk to me about the administration 2019 request of $250 million for pandemic

influenza. can you explain that authorization? , assume it is beneficial assumed this is me authorized. would you agree? >> it is absolutely essential, yes.ou -- >> a lot of the work has been done already with the investment that have been provided. we are made great strides with industry partners to make sure our country is better prepared for pandemic influenza. there is still a lot of work to be done. the availability of the vaccine as we create it, so it is available for all ages. we need additional antiviral drugs. we need more drugs and treatment options for people who are hospitalizedand with influenza. we need to do a better job with diagnostics as well.

we need to make sure that diagnostics is in the hands of those who need them so they can get treated sooner and take responsible actions to reduce the spread of that virus. context of still sustaining what we have built, we have to sustained infrastructure that is our response capability for a pandemic in our nation. the process of sustaining and filling in the gaps, that is how we would support and use those funds. talk about the importance of sustained and robust funding? sustained being the critical word here. why is that so critically important? >> the sustainment of the funding because we rely on the facilities of these companies to produce the vaccine. we need it quickly. they have the staff in place and capabilities in place and the fda is able to continue approving that facility. it is important that we do not

take our eye off the ball for sustainment. if a factory closes, we have no response. at the same time, we must sustain our momentum in supporting the phase one and phase two. technologiesbased and a regional manufacturing process across our country, so we can rely on those quickly during a pandemic. >> the chair will now recognize the gentlewoman from california for five minutes. was particularly hit hard by this flu season. in my home of orange county, it especially suffered with twice the number of flu cases compared to last year. orange county had at least a dozen influenza deaths in individuals under the age of 65. we know that seniors are particularly successful will --

susceptible to the flu. my district is home to a large retirement population. i am especially concerned about the health of this group during flu season. while the overall flu vaccine successful rate is 36%, the varytiveness rate can depending on age. the effectiveness rate for seniors last year was 28%. one would assume the rate is lower for vulnerable populations like seniors, but the 2016 and 2017 vaccine effectiveness rate was much more effective for children and other vulnerable populations. some of my colleagues asked what accounts for the variability in effectiveness among age groups. what can be done to improve effectiveness for seniors? >> i can begin.

there have been efforts to vaccinedifferent products, particularly for seniors and others with weaker immune systems area and one is a high dose product. a keyr approach -- strategy that we have at cdc is to make sure that patients and clinicians realize that high-risk the immune system does age and we think the frail her population have immunity. whatever we >> >> whenever we are making a vaccination for a possible pandemic about we always tested in healthy adults but also in the elderly. make sure that the dose and regimen gives a comparable response that a younger person at half.

that is part of the testing. the two major areas are the higher dose which is recommended for seniors. it is much higher than what you give a healthy young person. product isusing a not a vaccine but boosts a response. from endemicsson development. we know in the pandemic vaccine, we have to have higher doses of antigen. i recently, in the last few weeks visited the senior leadership and talk to them about this challenge. about how we can improve the effectiveness of our effective -- of our existing vaccines. inh is poised in strategic increasing the dose of the

actsing. they are all partnered an ell-based vaccines as well. >> i will just comment wrigley, --ath comment briefly, we are normal regular dose vaccine. i think, if we do observe differences between the high-dose vaccine for the vaccine with this relative, it could offer some clues as to our the vaccine was less effective overall against h3n2. we will make it available as soon as we have it. 2009 the fda approved

a high-dose vaccine for the elderly. it was 24.2% effective in renting the flu in adults aged defect and older. theyou elaborate on whether high-dose flexing would significantly reduce flu related deaths among seniors? 20% superior response is not 100%, because of the weaker immuno response seniors get. we have the market of the higher dose product has been increasing since it became available. recommend a not preference for the high-dose over a regular dose. one of the things we found is that the vaccine they have the doctors office is the one you should get. they may not have the other product if you are looking for it. the additional studies that the

done inoing and we have the past has helped us build an evidence-based of what is the best way to protect seniors. >> thank you. i am out of time. >> the gentlewoman yields back. chair will recognize mr. green. >> thank you, mr. chairman. i'm an alumni this committee. thank you for allowing me to be here. i would like to thank the chair for holding this hearing on the 201718 flu season. has been some advances and vaccine technology and antiviral drugs which reduce number of people get the flu. i understand there is a new vaccine production method based on recombining protein

technology that makes it less likely to mutate. dr. breitbart, there's been several developments on this technology. explain why there has been supported on these methods? >> thank you for that question. we primarily focus on technologies to respond faster and more effectively to a pandemic response. we know that you can cut out steps necessary to make a vaccine in an egg. you do not need a virus to grow the vaccine. you can start from the gene sequence and rapidly go into production. this offers great flexibility and speed compared to egg-based actsing.

we are learning that investments in those new technologies might also offer advantages of the template more effective flu vaccines. thatis critical to know is it is one thing to license those vaccines and make them available , but if they are not available in sufficient flu supply and don't have the capacity to produce it, that they will not penetrate the marketplace and the companies are frail and vulnerable after huge investment, if the vaccine is not used. >> thank you. commissioner, culinary data suggest that some of the newer 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 with the fda need to make a recommendation? >> > we're still evaluating from this reason relating to the high-dose vaccine. it's relative

effectiveness. when we start to speculate around different the raise on why the vaccine overall has been less effective, one of the theories that 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. it is something we will need to consider among many other possibilities as to why we have not seen a robust immune h3n2 fromgainst vaccines, generally. one thing we did observe so far this season was that the vaccine produced in cells, cell-based appear to- those do have provided more protection on a relative basis around 20% than the egg-based vaccines. again, we are not sure of the reasons why.

it does lead to some hypotheses around why may be generally speaking, we have not seen as robust a response as we would like. >> i know there are a number of new antivirals in the pipeline including some that may treat the virus at the beginning of the lifestyle your how did those differ from what is currently on the market how will they help us treat the flu in a new way? >> absolutely. i think it is important to recognize. the one class of drug that is effective this and inhibitor. it binds to an active pocket of a circus -- of a surface protein. it blocks a virus after it has replicated from breaking away from an infected cell. these new antiviral drugs are working on the replication cycle of the virus before it reproduces itself and bus away. because they work in different

parts, they also can be effective if the virus mutates and becomes resistant to a single class of drug available on the market today. it is critical to have different approaches to antiviral drugs. >> thank you. mr. chairman, i know i am out of time. i have other questions i would like to smit if it is allowed. i would to thank our panel for being here today. we're looking for the light at the end of the tunnel. i appreciate each of you all partnering together to deal with it. obviously, lewis terrible but there are lots of other books we would like to deal with. >> the gentleman feels back. i will remind members you have 10 is missed days. should you get additional lessons in writing, please respond probably. thank you for your time today. and weery informative enjoyed the flight is a division. i felt i should get some college credit for that.

but, to visualize that and see how it is better to attack the stem and set up ahead and give you a good visual, it was very informative and, one day we will then here and be discussing effective universal flu vaccine that we know we all desire to see. i hope we continue to take steps, even if they are nanoparticles caps to get to that conclusion. thank you to each of you for being here. this committee is adjourned. [captions copyright national cable satellite corp. 2018] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org]

[inaudible conversations] ♪ >> c-span's washington journal,

live every day with news and policy issues that impact you. coming up friday morning, author chris discusses of the role and the impact of the chief of staff in the modern era. a look at the justice department's lawsuit in california with jessica vaughan. be sure to watch washington journal each sunday for the special series 1968, america in turmoil, starting march 18. we look to a turbulent time in putting the vietnam war and a friend just presidential election. ♪ of thehis years studentcam competition, we etched -- we ask students to pick a provision of the u.s. constitution and create a video about why it is important. students compete to win cash prizes.

the first prize winner for the goesschool east category to students from montgomery blair high school in maryland. winners of the high school central category were students from whitefish bay high school in wisconsin. our studentcam's first prize winner for the high school west goes to students from capital high school in idaho. prize winner from our middle school east category our students from eastern middle school in maryland. our judges special citation for fromivity goes to students

a school in florida for their documentary. finally, we are happy to announce our grand prize winners , adam and tyler, from a high school in iowa for their documentary. we are calling because this year we have seen thousands of videos from almost 6000 students , and we are calling to let you know you won the grand prize. [cheering] [laughter] with this years topic, it was such an open-ended question, so we had time to focus. when i looked online and i got the contact information for the person, i thought, tyler, we have to do this. filming.mails, started

send more emails, and everything fell into place. >> picking the amendment was difficult. looked at amendments and evaluated. if there is lots of controversy right now in the public, so we looked at what affected us. contactable to get in with important people in iowa and around the country. the top 22 winning entries will air on c-span in april. you can watch every studentcam documentary online. ♪ >> president trump signed two proclamations to impose 25% tariffs on imported steel and 10% tariffs on aluminum.