Listen live on the free cspan radio app. Next, Public Health officials look at efforts to improve flu vaccines and have developed eight universal vaccine this Committee Hearing is about two and half hours. This hearing will come to order and without objection the chair has authorized to play recess at any time. Lets me say good morning and welcome to our witnesses t. Todays hearing on vaccine, science and innovation, smallest box smallpox once plagued the worlds population killing approximately 300 Million People the 20th century alone it. Smallpox is the only human disease to be eradicated thanks to the development of the vaccine. Another devastating disease, polio, had just 33 cases reported worldwide in 2018 compared to 350,000 cases in 1988. Everyday vaccines save lives especiallyly the lives of childn and other vulnerable population. There is no such thing as healthy skepticism when it comes to vaccines. Unfortunately, theres a wellfunded Disinformation Campaign targeting the public and weakening Public Health laws School Vaccination requirements have been commonplace in the usa for generations and exemptions were granted only for legitimate medical reasons. However, in my home state of texas the number of unvaccinated children has spiked since 2003. With the Texas Legislature expanded exemptions to include nonmedical reasons. The number of exemptions rose from 2000 in the year of 2003 to 57000 last year. We are seeing this replayed across the country and innocent children are falling ill. Health officials have concerned 20 confirmed 21 measles cases in texas this year in 1261 nationwide. 61 of which led to serious convocations. As the first nurse elected to congress, i have been dedicated to the improvement of Public Health my entire career. The Science Committee may not have jurisdiction over health and Human Service agencies,n but we have long had a role in supporting improved Public Health through good science. This morning we will explore the science and Innovation Challenges for Vaccine Development improving the lens of influenza for the healthiest among us, the flu just lays out for several the flu just lays us out for several days with no lasting side effects. However, for the very young, the elderly, pregnant women and other vulnerable groups the flu can be deadly. The centers for Disease Control recorded an estimated 48. 8 million in all illnesses and 79000 deaths during the 20172018 flu season. Approximately 600 of those deaths were children. Each year influenza vaccine production begins with the collection of analysis of data, many months before the beginning of the flu season. The challenge with influenza is that the virus changes constantly and by the time the flu season begins, the vaccine may not fully match the circulating viruses. Signed his are working to develop viable and more effective alternatives to the current egg based vaccine as well as universal vaccine that will now require annual updates, yet another scientific challenge of influenza and many other Infectious Diseases are complete is incomplete data and antiquated data systems. Through modernization of data system and data analytic tools acrosssy the federal and state level, we will be able to accelerate Vaccine Research and developments for many diseases. We have two expert panelists to help us understand the full cycle from basic research to Vaccine Development, production and deployment and surveillance. The witnesses will also describe the role of federal agencies, state agencies and the private sector including the partnerships imola and the among all of the stakeholders. I went to extend my warm welcome to all of you this morning and i want to thank the fisa chair for his leadership on this issue. I look forward to todays discussion. I might say i have a markup and another committee so i will have to leave before he gets relevant elaborations, but the chair will now recognize mr. Lucas for an opening statement. Good morning, chairwoman. I would like to thank you and the vice chairman for holding this hearing especially giving we are in the metal of flu season. The United States nearly a million individuals are hospitalized with the flu yearly including more than 40000 children. In oklahoma, since the 2019 flu season began september 1, we have had one death and 73 hospitalizations from the flu, however these numbers would be worse if we didnt have Vaccines Vaccination is by far the most the best flu prevention measure we can have today. Its easy to forget a little over 100 years ago the world faced one of the deadliest pandemics in history, the 1918h1 and one epidemic also known as spanish flu that killed an estimated 50 Million People worldwidesh including roughly 675,000 people in the us. Medical technology and countermeasures at the time were limited to isolation and quarantine. Influenza vaccines didnt exist and antibiotics had not been fully developed. Thankfully, due to research, advancements were made both inly treatment and prevention of the flu. The development of vaccines played an Important Role in reducing and eliminating deadly disease. I can recall my fathers stories about how late summer and fall were a terrifying time as a child because of the threat of polio during the seasons. Lucky for me i dont didnt have to experience this fear because of the first polio vaccine available in the us in 1955. Thanks to widespread Vaccination Police has been nearly eradicated in the us with only 33 cases reported in 2018. Polio remains a threat in some countriess with the world becoming more connected through modern transportation, it only takes one traveler with polio to bring the disease into the us and as im sure we will hear this morning from our witnesses, the best way to keep the us polio free is to maintain High Community through vaccinations. Considerable advancements have been made in technology, disease surveillance, medicine, drugs, vaccines while significant progress has been made gaps remain and a severe pandemic could be devastating to the global population. Of the population has grown so has the livestock swine and poultry population to feed them. This provides increased opportunity for unique virus. As a member of the House Agriculture Committee has supported the creation of the National Animal vaccine and that nearing countermeasures which was included in the last farm bill. This will maintain a sufficient quantity of animal vaccines and other measures to provide a Rapid Response if an outbreak were to occur and we were not prepared, and retirement Agriculture Sector would suffer losses. Not to mention the damage to human health. I look forward to hearing from our witnesses about the current state of our stockpile of human Health Vaccine to provide the capacity for Rapid Response to emergency situations. I look forward to hearing how influenza vaccine manufacturing infrastructure supporting the publicprivate partnerships with domestic vaccine manufacturers to increase preparedness levels and response capacity for potential pandemics. I would like to say how pleased i am to see the president recent executive order to address modernizing flu vaccinesor. The executive order recognizes influenza as aec Public HealthD National Security priority with the potential to inflict harm on the us in largescale illness and death. Most importantly, it establishes a National Pact task force to explore alternatives and new Technology Including a plan to laaccelerate the development of universal vaccines. On the board to seeing what recommendations come from the ou force and i would again like to take thank the chairman and vice chairman for holding this hearing and i would like to thank both witness channel and i yield back the balance of my chart time. They do very much. If there are members who wish to submit additional statements it will be added to the record at this point. At this time i will introduce our witnesses. First witness on the panel is dr. Jernigan. On disease at the cdc. Responsible for oversight and direction of a broad Scientific Program to include the detection, prevention, treatment and response to the pandemic the influenza is responsible for national and global surveillance. Influenza serves as a world health organization, collaborating center for control of influenza. 1994, as a retired captain of the Public Health service and recipients of the 2019 Service America would matter. The next witness on this panel is doctor anthony f, hes the director of the national into dude of Infectious Diseases. A hes been there since 1984. He oversees an Extensive ResearchPortfolio Research to prevent, diagnose and treat Infectious Disease such as hivaids, respiratory infection, diary disease as well as emerging diseases such as ebola. He also supports research on the transplantation and related illnesses including this order of asthma and allergies. He advised six president s on hivaids and many other domestic and Global Health issues. He is one of the present emergence plan of aids relief. A program that saves millions of lives. As our witnesses should know, you will each have five minutes for your spoken testimony. When youve completed your spoken testimony, we will begin with questions, each member will have five minutes. We will start with you. Thank you. Good morning. I am doctor dan, at the centers for Disease Control and prevention. On the think the committee to discuss supporting vaccine innovation to improve prevention of influenza. Each year influenza causes a Significant Health with many millions of americans, hundreds of thousands requiring uispitalization, tens of thousands dying. Influenza viruses are constantly changing, requiring every year. Sometimes these changes can be sudden and significant, resulting in strength second result in death. Hospitalization death can happen in any flu season and eight year flu vaccination prevent millions of illnesses thousands of severe symptoms with tragic outcomes. The vaccines are very safe and remain the single best way for people to fight the flu. Despite the significant benefi benefits, the effectiveness and the number of americans being vaccinated are not optimal. We are working with federal and State Government partners with the private sector to use cutting edge science to make influenza vaccines better. Longlasting broadly protected universal vaccine are the ultimate goal for flu prevention. These vaccines are still years away. In the near term, we can save millions of americans the flu by improving the vaccines back and produced using already available production platforms and by getting more americans vaccinated each flu season. Cdc has a s central role in evey part of the development in the administration cycle including continuous virus tracking around the globe, preparation of vaccine viruses,ro purchasing 1 of flu vaccines used in the u. S. And monitoring vaccine coverage, safety and effectiveness. To improve, they have implanted innovations throughout the lifecycle. Cdc invested in and collaborated with everyst state on flu surveillance. Ghis has resulted in automated realtime Electronic Laboratory reporting of influenza test results the cpc using messaging. Cdc has transformed flu virus by using generation genome sequences to received at cdc. We can track viruses much more quickly and accurately, leading to atomic selection and earlier detection viruses with potential. The sequencing equipment which once filled the room now fits in the palm of your hand. We have a mobile mini lab that can be taken on a plane as i carry on and set up almost anywhere in the world including constraintrce settings. Cdc has been fomented innovations for supporting work vaccines by developing candidate viruses for the self based vaccine by providing sequences to make protein vaccine. Both of these vaccines have the potential to be manufactured more quickly and may be more effective than traditional vaccines grown. Cdc routinely generates vaccine viruses using a technique called reverse genetics. This allows us to build a vaccine in a matter of days or weeks. Much faster than traditional methods making the u. S. More prepared to respond quickly to a pandemic. Cdc was the first to establish a National System for the routine monitoring of the effectiveness and that Network Provides critical information for manufacturers and researchers in developing enhanced vaccines by collecting more specific data about how well the vaccine works each season. Recently, we had expended an. Network with new immunity testing and conduct more studiej to better evaluate the effectiveness. Finally, a major component of improving the impact is getting more people vaccinated. You are than half of adults in the u. S. Receive the vaccine. Despite all successes in leadership in detection and prevention, theres still more we need to be able to do. Each of the topics i mentioned, tracking characterized viruses to developing vaccinehe candidas and studying effectiveness will benefit investments and generating more precise and timely data. We can make vaccines work better. In order to close by reminding you off to make sure you and your families are vaccinated before the Holiday Travel begins and thank you for the opportunity to talk about the work and i look forward to yourr questions. Thank you. Thank you, members of the committee thank you for giving me the opportunity to testify today. I am doctor anthony, i will talk to you in the next couple of minutes about the nihs efforts to improve the influenza vaccines and ultimately develop universal flu vaccine. As shown,fl although its very important to get vaccinated because even if a vaccine is not one 100 effective or even 50 the benefits to the individual to get vaccinated to the community is profound. We cant do product because the vaccines are not consistently optimally effective. We know pandemics occur but we usually are too late in ou response, as we work in 2009 h1 and one. Finally we spent considerable time what i call chasing after pandemics as we had h1 and one, we needed to do the investments but the pandemics never occurred. This slide shows a journal containing a number of papers in which my colleague and i in the introduction, emphasizing the point i just made that although influenza vaccines are good and important and should be utiliz utilized, we can do better but doing better, we need to improve the influenza vaccine which would need to a better capability to respond to pandemic influenza which ultimately will get us to the goal and that is the development of the universal vaccine. In the summer of 2017, we put together to develop a plan which was published in 2018 for the Strategic Plan and Research Agenda to formalize scientists throughout the country and the world to develop a universal flu vaccine. Er let me explain what we mean by universal flu vaccine. This is somewhat of a complicated side it really does make the point. We will talk about universal flu vaccine overnight. It will be a step process in which we go from improvement with broad capability of responding to a particular type of strain versus the ability to respond to all strains. Note on the lower lefthand side of the slide, divided into two groups of influenza. Group one and group two. On the right side, the tip of that triangle is what we do today. We make the vaccine for this season thats highly specific to the strains circulating the season. Those strains change and mutate, they drift. What we want to do is the next step is to make a vaccine that would cover all the h3 and to support all the h1n1. The next step would be to get one that would do all the group once and all group twos to ultimately we have a universal vaccine that essentially covers all of these. We will do that with new technology as you are aware, we currently have a w technique growing the virus in aides to develop the vaccine. Although that is true, its inefficient and has many areas of going wrong. We are fusing new platforms showed here in the slide such as proteins, viral vectors, nanoparticles and others. This is a blowup of the influenza virus and to the right is an important protein. Its important to know the hemagglutinin has two componen components, the head and stem. The head is the part that the body makes our response against but mutate often. It changes, leading to the ineffectiveness. The dark flu is the stem which doesnt change much at all. The strategy now, one of several strategies to develop a vaccine in which you cut off that head, take the stem and put it on a nanoparticles which will n ultimately serve as a vaccine. This is a 4 million times blowup of what the first universal flu vaccine would look like in these dark blue areas are the stem. Ar we have soldered a phase one trial here in the spring this year, it will be at the end of the next year end next year we will do a group to universal flu vaccine. As a president said in the executive order, the purpose of what we are doing is to go ahead and approve little by