And wanted to make sure when the case was over not only was edie still alive but healthy enough to enjoy it so that was very much weighing on me. I said forget it. No extension. Shes interviewed by zoe tillman. Watch book tv all weekend every weekend on cspan 2. And now a house subcommittee looks at u. S. Public Health Preparations for the flu season and other Infectious Diseases, witnesses testified about preparations under way as well as lessons learned. From earlier this month. This is about an hour 20 minutes. Good morning. We have this subcommittee hearing from oversight and investigation. Earlier this year in february this subcommittee held a hearing on last years flu vaccine mismatch. This mismatch to the predominant flu virus resulted in more deaths and hospitalizations because of the vaccines lowerthanusual effectiveness. Today we return to that issue to discuss what our Public Health agencies have learned in the intervening months. I want to thank the Ranking Member for her continuing passion on this important topic. We work closely sending bipartisan letters and sending briefings not only on this years flu vaccine but also our broader response to seasonal and pandemic flus. Influenza is a leading kawls of death in the United States especially in a severe flu season. Each year millions of americans receive flu shots to help protect against the illness. Getting a flu shot is important even in a bad flu season the vaccine can reduce the symptoms and duration of the flu and encourage everyone who has not received a flu shot this year to get one even if the vaccine is not perfect. Last year the United States experienced a severe flu vaccine mismatch and Public Health officials designed the vaccine based on Information Available in february but the virus mutated before the flu season began resulting in an effectiveness rate of only 19 of the vaccine and even lower for Senior Citizens. We have learned, however, even in a good year the effectiveness is lower than it should be. In four of the last ten years the effectiveness rate fell below 40 and its clear the seasonal flu can cause the same problem as a pandemic flu. The oversight work has made a difference. The department is now treating the seasonal flu as a high priority. Tools and plans typically reserved for pandemic flu situations are being considered in the fight against the seasonal flu. And hhs, Influenza Working Group has compiled 13 issues and recommendations to improve the Influenza Vaccine Development and manufacturing process. Theyre working to improve surveillance, utilize technology to speed vaccine production and make more effective vaccines, but theres still much work to be done. The issue surrounding the flu vaccine are not new. We are still largely manufacturing flu vaccine and detecting flu virus changes with Technology Developed during the 1940s. At the same time more and more influenza virus us are emerging each year. Increases in travel and trade make it easier than ever for these viruses to spread. Our Current System is not as responsive and effective as it should be. The system is badly in need of modernization and must better capture advances in technology over the past decades. We need better testing to quickly learn of mutations and seasonal influenza viruses, we must increase our capacity to create cellbased and recolbitant vaccine doses instead of relying on the more problematic eggbased vaccine doses. Et elits significant quicker tn eggbased vaccines allowing for greater flexibility in the vaccine selection and manufacturing process. Nih, the Biomedical Advanced Research authority and other agencies undertaking research in to influenza and the flu vaccine must determine what is limiting vaccine effectiveness particularly with respect to the seasonal flu strains. We must also better understand how to used ed adjuvants among elderly and the young. And the Public Health organizations must increase surveillance particularly in the Southern Hemisphere so we can know as early as possible when a seasonal flu vaccine wilmot be as effective as we hope. The cdc must have a more robust and Effective Communications strategy when dealing with the flu. In particular Health Care Professionals must be better educated by the use of antivirals instead of antibiotics when treating the flu. The cdc must come up with a better plan to increase vaccination rates and hhs must update its pandemic plans some which have not been updated for over a decade. And theyre long overdue. Im encouraged by the work thats been done but we must also ask ourselves where we are falling short and what we need to do to modernize our response. Our nation deserves a 21st century response to this problem. I thank our witnesses from cdc, fda, barta and nih and look forward to hearing their testimony today and i now recognize ranking ting member g y guette from colorado. When we had the h1n1 flu some years ago the concept of a flu pandemic and what it could do for our country and constituents and the world at large is what keeps me up at night. And thats why i think its important that we have a hearing every year. Im really happy were having it this year before the flu season has started. I think its really critical so that we can examine what what, first of all, whats happening with the seasonal flu as best as we can predict, and secondly, what were doing to prepare ourselves for better response to the seasonal flu and also more devastating potentials. I see we have some medical professionals in the room here. And im always happy to see it looks like youre students. My daughter is a medical student, so shes also very interested in these issues. Last year i think was a really harsh reminder that Infectious Disease is always around us. And try as we might, were not always 100 successful in treating the annual flu. Last years flu vaccine was only moderately effective. Fortunately it was not a severe strain, but nonetheless, it increased it results in increased hospitalizations particularly for vulnerable populations like Senior Citizens and Young Children. During the course of the last season, in fact, cdc announced that the flu vaccine had only a 23 effectiveness rate which is significantly lower than weve observed in recent years. That was largely because the virus mutated in the eight months between the vaccine strain selection and the onset of the flu season. And that resulted in a mismatch between the strain of the virus used in the vaccine production and the one that were actually circulating. Still, you know, we need to protect ourselves. And last year even 23 was better than nothing. But dr. Frieden reminded us last year that even a vaccine with a low effectiveness rate still protects millions of people from getting sick. And we hope, and i hear that some of the early indications are that its a better match this year. But its still kind of a crapshoot every year as to whats going to happen. So, thats why im always happy to have these witnesses here today, some of whom have been to this committee before, some are new, to hear about ways that we can strengthen our response for the future. I want to ask the cdc about this flu season, but i also want to hear how were going to respond in the event of the severe flu season and what were doing to continue to prepare for the inevitability of some kind of a pandemic flu. I was pleased to see that the administration put together a memorandum for the secretary of health and Human Services based in part on lessons from last years flu season. It offers several key areas where improvements could be made, including Better Technology to quickly identify and isolate flu strains and efforts to improve vaccine manufacturing. And the plan also provides rough estimates of when certain activities can be achieved and which agencies are responsible for each goal. But, mr. Chairman, as you pointed out, were still relying on eggbased vaccines even though we have better we have cellular techniques that are better. And frankly, this is the eighth hearing that weve had in the last ten years. And i remember ten years ago asking about the development of a new and more nimble vaccine potential and here we are again talking about this same thing. And so im really looking forward to hearing from the witnesses about the goals that they share and the memorandum that was issued, and also where we are towards moving towards better technologies on vaccine production and what were doing to improve all of the rest of our systems for more serious identification and prevention. The importance of a strong Public Health infrastructure that allows us to prepare and respond simply cannot be overstated. And were in a good position, but i think our position could be improved. We need coordinated response capabilities, Effective Communication strategies and critical investments so we can strengthen our response to all types of flu threats. And so let me conclude by thanking the witnesses and agencies here today. All of you i know are very committed to this effort. And we look forward to partnering with you in this ongoing fight. And i yield back. Thank you. Thank you. I dont think we have any on our side and given well be voting soon well submit those for the record and so if Ranking Member mr. Pallone wants to make a statement, you are recognized. Ill try to shorten it in light of what you just said. I just want obviously its important to remember that for many vulnerable americans seasonal flu can be dangerous. Older americans, pregnant women and Young Children are all the heightened risk for flu complications and hospitalization and death and last year we experienced a severe flu season across the country hospitalizations were up. Seasonal flu remains a significant Public Health burden that requires considerable attention from our Public Health officials. In addition the lag time between the selection of the strains for the flu vaccine and the completion of the vaccine manufacturing process raises inherent difficulties. We can all get vaccinated. Under the Affordable Care act flu and other immunizations are required to be covered by your Health Insurance without copayments or coinsurance. I went and got my shot this morning in the infirmary, it was free and its as easy as going to the pharmacy around the corner so theres no good reasons not do it. An annual flu vaccine continues to be the best method for preventing the flu. Even in a year where the vaccine is less effective flu shots still protect against and decrease the severity of flurelated illnesses. Unfortunately Many Americans still havent gotten their flu shots although weve made great progress vaccination lags behind in adults particularly in 18 to 64yearolds. And the mismatch vaccine during the 201415 flu season highlights the need to improve our vaccine manufacturing process as well as our capacity to conduct surveillance and virus characterization in cooperation with our global manman partners. I want to thank the witnesses for coming today. If i could submit my full statement to the record, mr. Chairman, id ask unanimous consent to do that. Without objection, well do that. If any other members have an Opening Statement and ask unanimous consent to have them submitted without objection and entered into the record. Id like to introduce the witnesses on the panel for todays hearing. Dr. Anne schuchat is the Deputy Director for the centers for Disease Control and dr. Robert rob certainson is from the development and Research Development authority within the office of the assistant secretary for preparedness and response, dr. Carol hallman is a director of the division of microbiology and infectious with the National Institute of health and dr. Karen medthune is the director of the center for biologics. We have a century of education at that table. Thank you. You aware the committee is holding an investigative hearing and when do so doing take testimony under oath. Do any of you have objection for taking an oath . Under the rules of the house and the rules of the committee you are entitled to be advised by counsel. Do you desire to be advised by counsel during their testimony today . Everybody says no. In that case would you please rise. Ill swear you in. Do you swear the testimony youre about to give is the truth, the whole truth and nothing but the truth . Thank you. All the witnesses have answered in the affirmative. You are now under oath and subject to the penalties set forth in title 18 section 1001of the United States code. I recognize you each for a fiveminute summary of your statement. Please try to keep it on time because were tight for votes. Doctor, youre first. Good morning, mr. Chairman and members of the committee, im the Deputy Director for the centers for Disease Control and prevention. I shared with the Committee Last february in the midst of the 201415 season that influenza is a formidable adversary. The propensity of influenza viruses to change presents unique challenges. New flu vaccines are made each year and updated as needed based on our best determinations of which viruses are likely to be most common during the next season. The Vaccine Development process is complex and time consuming. With the vast majority of flu vaccines still dependent on eggbased production technology. And while we tackle seasonal influenza we must conduct constant global surveillance and prepare for the emergence of dramatically changed or shifted influenza viruses that could trigger the next pandemic. The 201415 season was especially severe. The h3n2 viruses posed challenges even in seasons when vaccines and virus are well matched we tend to see more serious disease when these viruses are predominant. These viruses have been becoming more difficult to grow in eggs and last seasons viruses were difficult to characterize using the routine lab tests that still work well for other influenza viruses. The unique properties of h3n2 viruses present challenges for vaccine production. Last year we saw how devastating seasonal influenza can be. The severe season typical of h3n2 was exacerbated by those that drifted away from the strain used for Vaccine Development. We saw disappointing vaccine effectiveness against these viruses. We saw the highest hospitalization rates in people 65 and older that weve seen since this type of tracking began nearly a decade ago. Despite this, the vaccine actually worked well against influenza b viruses that also circulated last season. Ill briefly mention where we are now as we head into the 201516 flu season and then describe the steps weve been taking to improve our efforts in light of the problems we faced last winter. Currently influenza circulation is low and flu season hasnt yet begun. We cant predict exactly when flu activity will start accelerating or which viruses will circulate most commonly in the weeks and months ahead. Thus far we have seen more h3n2 viruses than h1n1 or b viruses. Lab data continues to indicate that most circulating flu viruses remain similar to the reference vaccine viruses used for development of the 201516 u. S. Vaccines. While we cant predict how effective this seasons flu vaccines will be the combination of this vaccine was updated from the 1415 one to better match circulating viruses and global Data Available right now suggest that vaccination with northern him miss fe hem miss fear should offer protection against the majority of viruses. I could speak at length about the significant improvements weve made to the Influenza Program over the last decade. Instead ill describe what cdc learned from the past season and what weve done to improve our ability to rapidly detect, respond and prevent flu. First we continue to work toward better detection of influenza viruses. And overcome challenges in characterizing h3n2 viruses. Were implementing new testing paradigms where we perform sequencing first on all specimens received for characterization. This gives actionable dater quicker than before and were working with Public Health partners to transfer the technology to them reducing processing time by weeks. Were developing better assays to characterize seasonal viruses and enhance our ability to identify emerging viruses. This season were implementing rightsizing initiatives with 64 Public Health labs. Weve put out the call to all our International Partners to increase frequency and number of specimens shipped to collaborating centers and were trying to retain the gains weve made in the last ten years in the global surveillance. Were working to provide better vaccines. And were increasing the number of viruses with the potential drift capability that are fully characterized as cell and egg propagated viruses to expand the pool of viruses available for vaccine composition decisions and were improving upon the vaccine virus selection process. Exploring a staggered approach whereby decisions about difficult vaccine components are made closer to the season and talking to the w. H. O. Flu network and manufacturers about moving the decision timeline as a whole closer to the season. Though, ive spoken about things wed like to do better i want to remind you the vast progress weve made in detecting, preventing and responding to influenza threats over the past decade. Flu is a formidable opponent, but cdcs working 24 7 to protect americans from this and other threats at home and abroad and im happy to answer questions. Thank you. Good morning, chairman murphy and sorry. Okay. Good morning. And i want to recognize the chairman, Ranking Member degette and the distinguished members of the subcommittee. Thank you for the opportunity to speak you with you today and im the deputy assista secretary fo ainter. We are charged with providing integrated Public Policy and Strategic Direction over the National Response framework and through barta overseeing advanced research and development and procurement of novel and innovative countermeasures such as vaccines and medical devices for the entire nation to address medical consequences of mand made and naturally occurring threats like the 2009 h1n1 pandemic and the 2013 h78 and 9 outbreak and the recent ebola outbreak. Weve managed over 80 medical countermeasures for influenza and 18 receiving fda approval and licensure since 2007 and six in the last three years. Additionally we developed vaccines used in the 2009 h1n1 pandemic and stockpiled vaccines for preparedness against h5n 1 to 9. With partnership with nih, cdc, and fda, industry and academia weve overcome but not all the vaccines for seasonal and pandemic influenza. They include first modernization of influenza vaccines through the development and licensure of new cell and recombitan vaccines. And third establishment and maint nance of prepandemic vaccine stockpiles for the viruses and expansion of domestic vaccine production to meet u. S. Pandemic vaccine needs. And lastly providing Emergency Response capabilities to develop, manufacture and test new pandemic influenza vaccines through our National Medical countermeasure response infrastructure. Despite the significant accomplishments our influenza preparedness work is not over. Incremental progress towards more effective influenza vaccines has been noted in recent years but much more is needed. Going forward there is reason for hope. That more effective influenza vaccines may be within our grasp. The discovery of new influenza viral targets and prime boost vaccine strategies may afford more durable and broader immunity and spark renewed interest in efforts to develop more effective influenza vaccines with universal protection. Were supporting the development of several new influenza candidates that may be more effective against a wider range of influenza viruses and that may serve seasonal and pandemic influenza needs. Additionally we are supporting new methods to help forecast the seasonal and pandemic influenza strains based on evolutionary technologies. With the hhs partners we are bringing a number of our advancements to pandemic influenza vaccines to address drift and seasonal influenza mismatch issues. These actions include better virus surveillance and characterization, new seasonal virus Risk Assessment tools, faster preparations of better candidate vaccine viruses, faster potency assays and more effective influenza vaccines. Beyond the successes weve achieved domestically improved global coordination is critical. Weve engaged our Global Partners several times this year on our improvement efforts for seasonal influenza vaccines. Recently we evaluated several actions in a table tom exercise with hhs agencies, w. H. O. , representatives from other countries and vaccine manufacturers. The exercise showed that several of these mitigation measures may improve the way that we prepare candidate vaccine strains and make seasonal influenza vaccines. In addition the exercise provided improved frame work on how the u. S. And Global Partners may manage viral drift and vaccine mismatches better. In conclusion influenza viruses that cause potential pandemics continue to evolve and change and infect animals and man and last Years Limited seasonal influenza effectiveness and this seasons arrival of bird flu virus underscore the need to meet the mission. We must continue to invest in preparedness and week with key Global Partners. Thank you for your generosity and i look forward to your questions. Thank you. Thank you. Mr. Chairman, Ranking Member degette and members of the subcommittee, thank you for the invitation to discuss the national knuts of health nih response to the Public Health threat posed by influenza. The National Institute of allergy and Infectious Diseases is the leading Research Agency for Infectious Diseases including influenza. Their mission balances research addressing current medical challenges with the capacity to respond rapidly to new threats for emerging and emerging diseases. Given the morbidity and mortality of influenza in the United States every year and the diseases economic burden their remains a concerted u. S. Interagency and International Effort to research the global emergence to make sure we are prepared for not only the coming flu season but also strains with pandemic potential. As part of this response our longstanding Research Program spans basic translational and Clinical Research and includes efforts to develop a universal influenza vaccine that could provide durable protection against a variety of seasonal and pandemic influenza viruses. Important to the effort is ongoing collaborations with academia and biotechnology and pharmaceutical industries and other federal partners particularly cdc, fda, asper and ba barta. We focus on understanding how influenza virus strains including those with potential pandemic potential evolve and causes illness in animals and humans. Among the ways we contribute to the fundamental knowledge is through the centers for excellence in Influenza Research and Surveillance Program which studies the global emergence and spread of novel influenza viruses and provides critical information to the World Health Organization. Naid also issues a bioinformatic approaches to learn how it changes over time and how it can be prepared to rapidly respond to the changes. For example, naid is supporting the development of a computational method to understand evolutionary changes to influenza. This method is now being applied to data from w. H. O. Collaborating centers to help provide information relevant to the strain composition of the annual seasonal influenza vaccine. In addition naid supported computational method known as antibody landscaping has enabled scientists to visualize how the human immune system responds to a lifetime of influenza infections. Its being employed to design advanced vaccines that may allow us to vaccinate against influenza strains that have not yet emerged. We support the development of diagnostic tools that examine the molecular makeup of influenza viruses to quickly distinguish between seasonal strains and those with pandemic potential. We are also supporting development of clinical assays to determine influenza sensitivity to inhibiters drugs that can lessen the severity and duration of influenza and potentially prevent influenza in close contacts with patients. We are also responding to the emergence of antiviral resistant influenza strains by exploring new and better Treatment Options including Broad Spectrum anty viral drugs and peptide inhibitors. As we all know annual influenza vaccination is the primary method to prevent seasonal influenza. Because influenza viruses evolve as they spread from person to person the strains used in the influenza vaccine must be reevaluated every year. The mismatch experience during 2014 and 15 flu season underscores the important of naids sustained support for Influenza Research and in particular work towards the more broadly cross protective or universal influenza vaccine that could generate longlasting protection against influenza strains over multiple seasons and enhance pandemic preparedness. Naid research on universal vaccine is focused on several concepts but the common principle behind each of these concepts is to identify the parts of the influenza viruses similar across multiple influenza strains and maximize the immune systems potential to respond to them. In addition to the efforts of naid scientists the institute in collaboration with barta is supporting a development of several potential promising universal influenza candidates by industry and academic partners. Although we cannot predict when the universal influenza vaccine would be publicly available naids lead effort has generated encouraging progress toward this goal. And its important to note that we develop universal influenza vaccines promising candidates will need to be evaluated over several seasons to determine the extent and durability of their protection. We are also helping to address scientific challenges in influenza virus production and naid is supporting efforts to create a flexible vaccine manufacturing process for seasonal Vaccine Development including modern molecular biological techniques to help increase production efficiency and shorten manufacturing time. And naid will continue to focus on advancing new tools to prevent, combat seasonal pandemic influenza and in combination with academia and the biotechnology institutes and pharmaceutical industries and other federal partners. Thank you for the opportunity to provide this overview of our Research Program. I would be pleased to answer any questions. Thank you. Please try to keep it for five minutes. Were running over here, thank you. Mr. Chairman, Ranking Member degette and members of the subcommittee, i am the director of the center for biologics and research. Thank you for this opportunity to be here today to discuss fdas role in the highly collaborative effort in preventing influenza through vaccination in the United States. Each year influenza causes illness in a large proportion of the u. S. Population and may result in serious complications including hospitalization and death. Influenza viruses continually undergo changes in their genetic makeup and the proteins that interact with the immune system, therefore, the combination of the influenza vaccines must be periodically updated to be effective against circulating viruses anticipated to predominate in the Upcoming Season. The strain of virus of the vaccine include two distinct subtypes of influenza a and one or two influenza b strains depending on whether the vaccine is trivalant or others. We study viruses from around the world and recent global disease patterns. Based on this assessment the w. H. O. Makes recommendations on the composition of the influenza vaccines usually in late february for the Upcoming Season in the Northern Hemisphere and in september for the Upcoming Season in the southern hem miss fear. The recommendations must be made months in advance because of the time required for manufacturing, testing, lot release and distribution of a very large number of vaccine doses. Each year following the w. H. O. Recommendations, fda convenes its vaccines and related Biologics Advisory Committee typically in late february or early march. The Committee Considers the w. H. O. Recommendations and reviews information regarding viruses that caused illness in the previous year, how these viruses are changing and disease trends. Based on the Data Available at the time of the meeting, the Committee Makes a recommendation for the composition of influenza vaccines licensed by fda for use in the u. S. During the Upcoming Season. Once the strains are selected candidate and influenza viruses adapted for high growth are generated and accepted by the World Health Organization Collaborative Centers for manufacturing vaccines. Fda then confirms the antigen suitabili suitability. The timelines are tight. No other vaccine is produced and fda distributed across the u. S. Within a sixmonth time frame. The estimate this season is that more than 170 million doses will be manufactured. Given the yearly need for new vaccine theres limited flexibility in the timelines for vaccine availability. And in parallel fda develops reagents. They are used by the fda and the manufacturers to test the vaccines for potency and identity before the u. S. Formulation is approved. Manufacturers submit their vaccine testing results along with samples from each lot for fda lot release. As the fda releases lots the manufacturers can make the lots commercially available throughout the u. S. Every year the fda begins working with manufacturers for the early stage of the Vaccine Development process and we continue to assess throughout the production phase. We engage companies and technical and manufacturing issues and conduct facility inspections to ensure compliance with good manufacturing practice. As part of the process, hhs staff with expertise in influenza convene monthly at the pandemic and seasonal influenza Risk Management meeting. This group deliberates policy and programmatic issues. Hhs has taken a series of steps to increase the probability that a late season change to the vaccine could be made or that a supplemental vaccine could be produced if warranted. Several actions by hhs were proposed and tested and will be further refined based on a tabletop exercise conducted on november 10 with hhs agencies and other Global Partners. Despite the difficulties inherent in preparing the vaccines weve made progress with the efforts in collaboration with barta and cdc and nih and other stakeholders. New influenza vaccines have been licensed, including cell based vaccines and others. Fda licensed an adjuvant of a bird flu vaccine and worked with other partners to facilitate other Avian Influenza a. Surveillance efforts offer potential for early viruses. The number of candidates has increased greatly over the last few years providing them with more options. We continue efforts with our government partners to develop highyield candidate vaccine strains as well as more modern faster methods to measure vaccine potency. To further address the challenges presented by the constantly changing airport in of influenza viruses scientists affiliated with government and academia and manufacturers are working to develop new generation of vaccines that might provide longer lasting and broader protection including against drifted strains. Although the Development Efforts are still in the early stages, some may have the potential to increase and broaden protection against influenza. We will work with u. S. Government partners, manufacturers and other stakeholders to continue to facilitate the development of new vaccines and identify methods that will speed the manufacturing process. Thank you. I thank you and look forward to any questions that you have. Well get to as many as we can and take a break and get back. Let me recognize myself for five minutes. Have the influenza strains grown increasingly complex and are they being distributed more broadly across the globe now . Cdcs expanded our surveillance so that we do have testing of viruses from more and more places but we actually need to do even more. The h3n2 virus showed us that the strains have evolved away from the tools that weve been using. Weve had to modernize our tools and move to a sequencefirst approach which helps us overcome the old hi test that wasnt really helping us understand the distribution of strains, so there have been important changes in the evolution of h3n2 that have made it difficult with the old tools to track whats going on. Theres been a large increase in human infections with influenza a vie ruls over the past 20 years. Is it true that there are many new types of highly infectious influenza strains . Why the range in types . Weve increased the sophistication of testing and were picking up the unusual types th s that jump from anima people. Its difficult to say if its happening more or were finding it more. Weve increased the global capacity to recognize influenza, test for it and provide specimens that can be further characterized. Is part of it also that theres the issue of increased International Travel and trade thats also spreading faster and influencing some of this . Theres so many factors that have made infectious threats greater and greater today. The closeness with animals and people interact and some of the manufacturing and agricultural practices around the world. And travel and trade means that people are in contact with each other in different ways not just for influenza but for many threats we see infections could be here at home soon. What youre talking about, then, youre picking up more. Theres increased threat. Unpredictability but has the flu modeling really changed to more accurately reflect the best information of flu virus . Is it being changed to more accurately prepare for an influenza vaccine . The application of modeling approaches to the genetic data has advanced substantially. We have an enormous amount of genetic sequence data now that is being used in more sophisticated ways, so we think this is a very important tool for the future to actually use modeling really to predict what would be better that could make better vaccines. In another area, doctor, are serum banks useful for testing candidate viruses for the flu vaccine . And if so, could more use of serum banks help provide better sampling for testing candidate viruses . Im probably not the best person to answer that question. Who would be . But i could i could begin. Okay. Basically the ways that were testing candidate vaccine viruses or that were testing circulating viruses include old tools and new tools. We have been using this hi inhibition test which was developed in the 40s and is really not working anymore for the difficult strains. Were switching to neutralization assays and to synthetic receptor models that wed like to invest in. Sear rucrum banks is the corner but others may want to chime in. Do any others have thoughts on that . If not, ill go to my next question. Are there any studies underway looking at the profile throughout the country to determine if there is any regional differences on what influenza viruses are predominant and what traces of immunity are in local populations . You know, thats a very interesting question. Thats why i asked it. You know, weve expanded our Vaccine Effectiveness Network in the u. S. To have more communities included in larger numbers. One thing that we found last year with the difficult strain that we and the drift was the vaccine effectiveness was poor generally but in one area which happens to have been pennsylvania the vaccine worked quite well. And we think that the strains that were circulating in pennsylvania were of a different clade or subtype. They were the old strain and not the drifted one, so, in fact, the vaccine worked better than most places in pennsylvania. We think its really important for us to have lots of viruses and to test them with the best tools so that we really can understand whats circulating and that we need very good vaccine effectiveness platforms both in the United States and in the Southern Hemisphere to really understand how the vaccines are performing in actual use. Not just predicted to perform through the lab assays before we start using them. Thank you. My times expired and now recognize ms. Degette for five minutes. Thank you, mr. Chairman. Im always encouraged to hear researchers and experts come in and talk about the new Development Methods that we are beginning to achieve for for flu vaccine. But were still primarily using eggbased technologies to produce the flu vaccine right now in this country, correct . Its correct that most of the influenza vaccine is produced with eggbased technology. And one of the problems with eggbased technology is that obviously it takes time if the virus should mutate or need to be changed, is that correct . It does take time but it also takes time if you make the product using cellbased or other technologies. There may be some time savings but nontheless you need to be able to have the virus that will grow well in the cellbased as well as the others. The other problem is weve seen in past hearings is that if you have some kind of a pandemic, then the additional problem to the time it takes to grow the virus in the eggs is the egg availability. We saw that with the avian flu and other things, is that correct . You know, i might ask dr. Robinson to add here but actually a lot has been invested in both all im asking is it takes a lot longer if you have to rapidly grow vaccine in eggs to get the eggs. Yes or no . It depends. In general it is possible to get a virus that will grow more quickly in a cellbased system than in an eggbased system. Look, i have five minutes. Yes or no. If you have to increase egg production it is takes a long time, is that right . Okay, never mind, youre not going to answer my question. Let me ask you, dr. Robinson, because you testified that weve developed a lot of these new technologies but theyre not being used on a routine basis to to for the seasonal vaccine, is that correct . Both cellbased vaccines are licensed for seasonal purposes. Thats correct. But theyre not being used widely, isnt that correct . Thats correct. Now, why is that . Theyre competing with the industry where you have egg based and theyre new to the enterprise and they are fighting it out in the marketplace. Part of the problem is its a marketbased technology. Correct. And so it costs more money, right . So far, thats correct. Okay. Now, what how do you see the markets moving particularly with development of pandemic types of vaccines . Would we be able to be nimble enough to use those new technologies if we had some kind of pandemic flu and how long would it take us to ramp up . So, to answer your question, yes. They are part of what we do for pandemics. They have been part of what weve developed and theyre part of our capacity to make the u. S. Independent of other countries providing those vaccines so how long would it take . Because right now we dont have a stockpile of pandemic flu vaccine. We have stockpiles for h5n1and others. Some of those are ten years old, right . We actually are testing those exactly right now, in fact. Oh, good. To see whether or not theyre still good. The potencies, though, are good. Can you supplement your testimony to let us know if they are good . I would be happy to. That would be good. Lets say we had a new strain of avian flu or some other kind of pandemic flu, how long would it take us to develop those vaccines, then . Having been around for the h1n1 it took 23 to 25 weeks for us to start to actually have a vaccine available in october of 2009. And h7n9 2013 we broke that record by several weeks, in fact, and we now have more tools that we can actually go a little bit faster if we start for a new pandemic. Heres the so, what, you think you could go down to, like, 20 weeks . Our goal, our aspirational goal is to actually have the vaccine in four months. Okay. So, the problem is, of course, which we all understand, is if you see if you see a pandemic flu four months is going to be a long time to try to develop a new vaccine. And that are there ways that you think with our support we could get that even shorter . Certainly if we can keep all of these manufacturers going for both seasonal influenza vaccine markets, then we have a greater chance to have those available and make larger predom naginanc available both seasonal and pandemic. Im out of time. And were trying to get a lot more questions in. And i have a lot more answers, if you could respond in writing. Thank you. Mr. Collins for five minutes. Thank you, mr. Chairman. Maybe to followup a little bit on ms. Degettes questions, dr. Robinson, on the pandemic flu, the h1n1, thats been in stockpile for ten years, whats your since its never humans . There has been a number of individuals that have been infected with h5n1. Right but it didnt jump. Its not easily transmitted mantoman. Right. What basis did you characterize or decide how to produce the h5n1 vaccine since its never really jumped from animals to humans . Weve been working over ten years to put together the h5n1 vaccine plans with cdc and with Industry Partners and were actually able to successfully make the first one that was licensed in 2007 more recently with adjectvents. We can do it quickly. We had an experience in 2013 for another Avian Influenza virus in which we were able to use egg, cell to make those vaccines sooner. So lets say that something happens and it does become a pandemic, is your organization looking at any post symptomatic treatments . Its so deadly, especially in this case healthy individuals for any post symptomatic treatments . Weve invested heavily in new antiviral drug treatments. Those have been approved by the fda. Were looking for immunotherapeutics, antibodies. Monoclonal or polyclonal . In our case, monoclonal squl why not polyclonal . If theres a good case. Right now the monoclonals have several advantages. On anything that mutates as rapidly as this virus they are targeted to regions of the virus that do not mutate. Is your opinion that the stockpile we have add equate . Strategic National Stockpile before it is designed and equipped to handle for what we would have. So you have done that only to make it a more potent, if you will, vaccine that would originally why we used adjuctvents that we couldnt have enough. Makes it more potent . Makes it more potent but it also actually allows now, we understand, for the vaccine to protect against different strains of influenza. The elderly sometimes are more at risk just because of their health. And is that a population where we might have two versions, one ajevented, one not . There are more than one formulations for the elderly. A highdose formulation has been licensed for the elderly. So i think we really do focus on the elderly, who suffer the most from influenza in most seasons with hospitalizations and deaths and in a pandemic typically not the 2009 now but typically would also suffer extensively. We think better vaccines are important for that population. Theres been a lot of progress and theres more progress we look forward to in the future. Currently there is not an ajevented version . Not yet but theres one under revie review. We have one for 65 years old discussed in an Advisory Committee two months ago and currently is under review. It shows it compared the immune response to the adjuvanted. Thank you very much. We have about
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