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 spo