This hearing will come to order ask without objection the chair is authorized to declare recess at any time. Let me say good morning and welcome to our witnesses. Todays hearing on vaccine science and innovation. Smallpox once plague said the worlds population plaguing 300 Million People in the 20th century alone. 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. Every day vaccines are saving lives especially the lives of children and other vulnerable population. Theres no such thing as healthy skepticism when it comes to vaccines. Unfortunately, there is a wellfunded, Disinformation Campaign targeting the public and weakening Public Health laws. School vaccination requirements have been common place in the u. S. 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 when the Texas Legislature expanded the exemptions to include nonmedical reasons. The number of exemptions rose from 2003 to 57,000 last year. We are seeing this replayed across the country and innocent children are falling ill. Health officials have confirmed 21 measles cases in texas this year, and 1261 nationwide. 61 of which led to complications. I have been dedicated to the improvement of Public Health my entire career. The Science Committee may not have jurisdiction over the health and Human Service agency, 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 through the lens of influenza. For the healthiest among u the flu just lays out for several the flu just lays us out for several days. However, for the very young, the elderly and pregnant women and vulnerable groups and the flu can be deadly. The centers for Disease Control recorded an estimated 48. 8 million illnesses and 79,000 deaths during the 20172018 season and approximately 20 of those deaths were children. Influenza vaccine production began with the analysis of data many months before the beginning of the flu season. The challenge with influenza is that the viruses change constantly and by the time the flu season begins the vaccine may not fully match the circulating viruses and scientists are working to provide viable and effective, for the eggbased vaccine as well as a universal vaccine that would not require an annual update, yet another scientific challenge for influenza and many other Infectious Diseases are incomplete. Disease is incomplete data and antiquated data systems. Through modernization of data systems and data analytic tools across the federal and state levels we will be able to accelerate Vaccine Research and development for many diseases. We have two expert panels that will 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 among all of the stakeholders. I want to extend my warm welcome to all of you this morning, and i want to thank the vice chair, dr. Berra for his leadership on this issue. I look forward to todays discussion. I might say that i have a markup in another committee so i will have to leave before we get through all of the deliberations and the the chair will recognize mr. Luca. Good morning. I would like to thank you for holing this hearing especially when were in the middle of flu season. Nearly a million individuals are hospitalized for the flu every year, including more than 48,000 children. In oklahoma since the 2019 flu season began on september 1, theres been at least one death and 73 hospitalizations from the flu. However, these numbers would be far worse if we did not have vaccines. Vaccination is by far the best flu prevention measure we can have today. Its easy to forget that a little over 100 years ago the world faced one of the deadliest pandemics in history the 1918, h1 epidemic also known as spanish flu. It killed an estimated 50 Million People worldwide including 675,000 people in the United States. Medical technology and countermeasures at the time were limited to isolation and quarantine. Influenza vaccines did not exist and antibiotics had not been fully developed yet. Advancements were made in treatment and prevention of the flu. The development of vaccines has played an Important Role in reducing and eliminating deadly disease. I can still recall my fathers stories about how late summer and fall were a terrifying time as a child because of the threat of polio during those seasons. Lucky for me, i did not have to experience this fear because of the first polio vaccine being available in 1955 and thanks to widespread vaccination, polio has been eradicated in the United States with just 33 cases reported in 2018. However, polio remains a threat in some countries with the world becoming more connected through modern transportation, it only takes one traveler with polio to bring the disease into the United States. As im sure well hear this morning from our witnesses the best way to keep the United States poliofree is to maintain high immunity through vaccination. Considerable advancements have been made in health technology, disease surveillance, medical care, medicines, drugs and vaccines and pandemic planning while significant progress has remained and gaps remain and the severe pandemic could still be with the human population, as the human population has green so has the swine, livestock and poultry populations to screen them. Birds, cattle and pigs to evolve and infect people. As a member of the House Agriculture Committee i supported the National Animal vaccine and veterinarian Counter Measures bank which was included in the last farm bill. This vaccine bank will have vaccines and other countermeasures to provide a disease outbreak. If an outbreak were to occur and we were not prepared our entire Agriculture Sector would suffer immense losses causing longterm harm of the livestock, poultry and swine production, not to mention the damage to human health. I look forward to hearing from our Witnesses Today about the current state of our stockpiles of Human Health Vaccines to provide the capacity for rapid responses to emergency situations. I particularly look forward to hearing how barta influenza vaccine infrastructure is supporting the Public Private partnerships with the capacities for potential pandemic flew events in the United States. Lastly, i would like to say how pleased i am to address modernizing flu vaccines. It recognizes that influenza as a Public Health and National Security priority with the potential to inflict harm and death. Most importantly, it establishes a National Task force for new technologies including a plan to develop flu vaccine. I would like to thank chair johnson for holding this, and i would like to thank the panel for sharing your expertise and insights this morning and i yield back the balance of my time, madam chair. Thank you very much. If there are members who wish to submit your Opening Statements your statements will be added to the record at this point. At this time i will introduce our witnesses. The first witness on the panel. Our first witness is dr. Daniel jernigan a jernigan. He is responsible for oversight and direction of a broad, Scientific Program to improve detection, prevention, treatment and response to a seasonal novel and pandemic influenza. The Influenza Division is responsible for national and global surveillance of influenza and serves as a World Health Organization collaborating center for the surveillance epidemiology and control for influenza. Dr. Jernigan entered the cdc in 19954 and is a captain of the Public Health service and was the recipient of the 2019 america gold medal. The next witness on this panel is dr. Anthony fauci. Dr. Fauci is the director of the National Institutes of allergy and Infectious Diseases, a position hes held since 1984. He oversees an Extensive Research portfolio of basic and applied research to prevent, diagnose and treat Infectious Diseases such as hiv aids, respiratory infections and diarrhea diseases, tuberculosis and malaria as well as emerging diseases such as ebola and zika. He also supports research on the plantation and immunorelated illnesses including the antiimmune disorders asthma and allergies. He has advised six president s on hiv aids and many other domestic and Global Health issues. He was one of the principal architects of the president s emergency plan for aids relief, a program that has saved millions of lives throughout the developing world. As our witnesses should know you will each have five minutes for your spoken testimony. Your written testimony will be included in the record for the hearing. When youve completed your spoken testimony we will begin with question, each member will have five minutes to question the the panel. We will start with dr. Jarnigan. Thank you very much. Good morning chairwoman johnson, Ranking Member lucas and distinguished members of the committee. I am dr. Dan jernigan at the centers for Disease Control and prevention. I want to thank you for the opportunity to report prevention of influenza. Each year, influenza causes a Significant Health burden in the United States with many millions of americans becoming ill, hundreds of thousands requiring hospitalization and tens of thousands dying. Influenza viruses are constantly changing, requiring us to update the vaccine components every year. Sometimes these changes can be sudden and significant, resulting in flu strains that can lead to devastating pandemics. Hospitalization and death can happen in any flu season and each year flu vaccination prevents millions of illnesses and thousands of severe and sometimes tragic outcomes. Influenza vaccines are very safe and they remain the single best way for people to fight the flu. Despite the significant benefit, the effectiveness of the flu vaccine and the numbers of americans being vaccinate are not optimal. We at cdc are working with nih and other federal and State Government partners to use cutting edge science to make influenza vaccines better. The broadly protected universal vaccines that dr. Fauci will talk about is the ultimate for flu prevention, however, these vaccines are still years away. In the nearer term we can save millions of americans from the flu by making incremental improvements for vaccines that can be produced by production platforms and by getting americans vaccinated each flu season. Cdc has a central role in every part of the Influenza Vaccine Development and the influenza cycle including virus tracking around the globe. Preparation of vaccine viruses. Purchasing 10 of flu vaccines used in the United States and monitoring vaccine coverage, safety and effectiveness. To improve flu vaccine, cdc has projected the cdc life cycle. Cdc has collaborated with every Public Health tomorrow p this has resulted in realtime reporting of influenza test results to cdc using cloudbased messaging. Cdc has transformed surveillance by using genomic sequencing to characterize all specimens received at cdc. This means we can identify and track viruses much more quickly and accurately leading to more timely selection of candidate vaccine viruses and earlier detection of viruses with pandemic potential. The sequencing equipment which once filled a room now fits in the palm of your hand. We now have a mobile mini lab that can be taken on the plane as a carryon and set up almost anywhere in the world including rural, resource constraint settings. Cdc has supported newer vaccines by developing candidate vaccine viruses for the cellbased vaccine and making the protein vaccine. Both of these newer vaccines have the potential to be manufactured more quickly and maybe more effective of traditional vaccines that are grown in eggs and 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 system for the routine monitoring of the influenza effectiveness and the Vaccine Network provides critical information for manufacturers and researchers and developing enhanced vaccines by collecting more specific data about how well the vaccine works each season. Recently, we have expantded the network and are planning to conduct more studies to better evaluate vaccine effectiveness. Finally, a major component of improving vaccine impact is getting more people vaccinated. Fewer than half of adults in the u. S. Receive their influenza vaccines and despite all of our successes and our Global Leadership and influenza detection and prevention, there is still more we need to be able to do. Each of the topics i mentioned today from working with domestic Public Health partners to track and characterize viruses to developing vaccine candidates and studying vaccine effectiveness will generate more precise and timely data. I believe we can harness this to make vaccines work better. I want to close by asking you and your families to get vaccinated before the Holiday Travel begins, and i look forward to your questions. Thanks. Thank you, dr. Jernigan. Dr. Fauci . Thank you very much, madam chairwoman. Members of the committee, thank you for giving me the opportunity to testify. I am director Anthony Fauci from the, in ih and i will talk to you over the next couple of minutes over the nihs efforts to improve influenza vaccines and to develop a universal flu vaccine. As shown on this slide, although as dr. Jernigan its very important to get vaccinated because even if its not 100 effective or 50 effective, the benefit for the individual to get vaccinated and the community is profound, however, we can do better because seasonal influenza vaccines are not consistently optimally effective. In addition, we know through history that pandemics occur, but we usually are too late in our response as we were in the 2009 h1n1 and finally, we spend considerable time what i call chasing after pandemics as we had with the h5n1 and h 7 n 1 in which we made significant investments and we needed to do that, but those pandemics never occurred. This slide shows a journal, the journal of infection diseases containing a number of papers in which my colleague and i gave the introduction emphasizing the point that i just made that although influenza vaccines are good and important and should be utilized, we can do better. By doing better we need to improve the seasonal influenza vaccines which would lead to a better capability to respond to pandemic influence that which will ultimately get us to the goal that well speak about over the next minute or two and that is the development of a universal influenza vaccine. In the summer of 2017. We brought a group together to develop a plan which we published in 2018 for the Strategic Plan and the Research Agenda to mobilize scientists throughout the country and the world to develop a universal flu vaccine. So let me explain what we mean by universal flu vaccine. This is somewhat of a complicated slide, but it really does make the point. We will not get a universal flu vaccine evernight and it will be a step wise process in which we go from improvement, the broad capability of responding to a particular type of a strain, versus the ability to respond toa all strains. And notice its divided into two major groups of influenza. On the righthand part of the slide is the tip of the triangle. We make it thats highly specific that are circulating the season. However, they change. They mutate and drift. What we want to do is go to the next step is to make a vaccine that would cover all of the h 3 n 2s or all of the h1n1s and then the next step would be the one that would do all of the group 1s and the group 2s until we have a universal vaccine that essentially covers all of these. We will do that with new technologies as you are well aware. We currently have a technique of growing the virus in eggs to develop a vaccine. Although thats time, true and time hon rd, its ineffect and has many areas of going wrong. So were using new platforms as shown here on the slide such as recombinant proteins and viral vectors and nano particles and others. This is a blowup of the influenza virus and to the right is an important protein called the heem hemogluten. It has two components called the head and the ste