Transcripts For CSPAN2 House Hearing On The Flu Vaccine Part 1 20240713

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 Health D 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 Research Portfolio 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 little to get vaccines to protect us in the most efficient way. Possibl. We will hand out rounds of questions. This information campaign, in confusion and fear, this campaign carefully targets on different populations with different release belief systems. Innocent children are falling ill today with diseases we once thought were eradicated in the u. S. Young women are necessarily being put at risk of cancer. We are clearing a challenge in vaccination efforts. How big of a role does social media play in this . How can we have these tactics . What is cdc doing specifically to combat these efforts . This is certainly doing everything we can to get more people vaccinated. Only half on what americans get vaccines, the other half still need to get vaccinated. One of the reasons why theyso dont is because theyre worried about the effectiveness. Roimproving the effectiveness of the flu vaccine certainly what get more people to get vaccinated. Your question is around the misinformation and social media ofd participating in that. We do think there is a lot of information about. Parents have different places they can get information and a lot off times they dont know which iss signed based or evidencebased. I think at cdc, our plan is to strengthen public trust in vaccines by truly trying to get peoplet to be more confident in the vaccines, getting the information author about how effective they are in it comes down to three things. Protecting the Community Helping to understand the differences in the different pockets of the communities. Ni what makes them not have as much confidence in the vaccine as they should and identify Development Materials we can use for those specific communities reaching out to Leaders Within the communities. A second thing would be to empower parents. Young parents when they first have children or pregnant women, get them to the right information and understand better the benefits of vaccines and understand why its so important to get vaccinated and work with clinicians so they have the tools to talk with the family members as well. Finally, to stop them as much as possible, we do that by providing scientific based evidencebased information author on our website and working to make sure that can be reused multiple different platforms so people can get that evidencebased information. Thank you. Would you like to comment . Yes, if you do a survey and find out why people whats the most important reason why people dont get vaccinated for influenza and its because of the socalled misperceptions that it really doesnt work, i think we need to emphasize even though it isnt one 100 effective, even a modestly effective vaccine will prevent blu from, particularly those susceptible to complications will prevent them from getting hospitalized and ultimately saved their lives. This perception vaccine doesnt work, we need to put that aside because everyone should get vaccinated. Thank you. In oklahoma, the state department reported influenza already claimed one life and hospitalized 70th others. Continuing on the comments that you have made, when im with my constituents back home, stressed the importance of getting vaccinated and prevent hospitalizations. Can you expand on that . Youre looking my neighbors in the eye, this is rural oklahoma, youre talking about things to the point. We know the burden of influenza is very high. Illnesses and death that occur because of influenza. There are tens of millions of cases every year. Hundreds of thousands of hospitalizations and tens of thousands of deaths that occur every year. We note with a vaccine thatt we can prevent thousands of deaths every year and tens of thousands of hospitalizations. Its important to get vaccinated but not just for yourself but it because it protects the Community Around you. There are a number of advantages that the vaccine has. It prevents you from getting sick, it reduces you from having to be hospitalized. People with underlying chronic diseases, its like a prevention 12. You should take it every year because it can keep you from getting a second heart attack. It protects pregnant women and their babies so they can get the pregnant mother vaccinated, it helps the baby before they can get vaccinated. It is life saving in children, it reduces the chance of death by 65 . There are a number of things that are important, even if its not one 100 effective, it can reduce the severity of illness during the flu season if you were to get infected. My background is in agriculture and we have the Robust National stockpile which provides farmers with protection. Can you speak to the current chain of the Human Vaccine and what we can do to better prepare and address potential pandemic emergence of these . Are the to do that except the cpc i will forward it to you then. Hes the one who manages the vaccine we can reassure the folks back home that we are paying attention, you are taking care of their best interest. In terms of what we do at cdc, we monitor influenza around the globe, especially the swine influenza viruses emerging around the globe. We do that through laboratories and detect dose and take the information and use it in the influenza Risk Assessment tool. You can get on your browser and see a graph of where we have ranked these concerning potential pandemic virus in that graph. With that, work with the rest of the agency, should be made into vaccine candidates which should be made into vaccines and stockpiles so with that, we have made decisions about the best stockpile so the u. S. Is prepared. Many of those vaccines, its in the vaccine stockpile. It may be enough to vaccinate to First Responders and few small risk groups but these virus continue to be contained. Its important for us to find new vaccine technologies so the vaccine stockpile isnt something that has to keep getting more and more put into it but rather upstream, we have fast technologies and make vaccines quickly and ultimately the universal vaccine for us to prevent pandemics to have that available. Before i yield back, i alluded in my opening statement, in the 40s and 50s, the development of the polio vaccine and 55, they kept seemingly getting worse and worse. The sheer terrorin of it in the communities, my generation was not a life for that and did not experience that. It was terrifying. My first job when i was 14 was a country cemetery, i have great aunt is the family historian and i remember asking herer why are all these babies buried . Why are all these young women buried . She said look at the tombstone. They say 1918 19. Spanish flu took them all. It brought even in rural oklahoma brought society to a grinding halt for weeks and weeks as it passed through. My generation have not experienced any of that, sometimes it doesnt necessarily understand what the potential downside is. Thank you, doctor for giving this opportunity to focus on these issues. I yield back. Thank you to the Ranking Member and for allowing me to be a doctor check. There a couple of things happening, the most important thing at stake today, i think thats why cameras are out. A colleague of mine, we are on the front lines of trying to combat this information up there. I want to run through a couple of quick yes, no questions. Is there any Scientific Evidence that vaccines leading to increased risk of autism . Absolutely not. When i was practicing, i would talk to some of my patients, they would often come back and say dont want to get the flu vaccine because i had before and it caused the flu. Is there any evidence the flu vaccine causes the flu . The flu vaccine does not cause the flu. Does not cause the flu. The whole point of scientists to pursue the truth, its important for us to withdraw the smiths, there are legitimate reasons for individuals who have allergies to opt out of the vaccine but one of the most important things about why its important, measles as an examp example, the concept of herd immunity. I think its important for the public to understand that particular concept. Its a very important concept, not only the flu but our recent unfortunate experience that we had in this country particularly in new york city, a classic example of what happens when the umbrella of herd immunity goes down below a certain level. You had a community in which the level of vaccination was somewhere between 70 80 . For measles, you need 91 93 or more so when inevitably coming in from the outside, when someone travels and bring backs it, the community isnt protected, you get the unfortunate situation in which we saw in brooklyn. What are the current rates in america . Over 90 . So we want to keep that. Measles is a disease that for the most part, we have eradicated. Now we are starting to seek that from the incidences popping up again. How often do you hear individuals say we dont need these vaccines because we havent had a pandemic like this for 100 years. Can you talk about why we have been so lucky. This is a situation where the flu virus is circulating in animals. When they do that, they can share their genes and create flu virus that has not been seen before. You can spread quickly through the community and cause severe death and illnesses and hospitalizations. 1918, one of the worst that clearly caused at least 675,000 deaths in the u. S. Weve had three other pandemics in the last 100 years. They were changes in the vaccine that were not as bad. We have looked at the 1918 virus and found there particular changes in that virus that made it severe so theres nothing preventing that from happening again. For us, its important to maintain and seek whats happening and maintain the ability to have Vaccines Available quickly so we can get it and be ablele to prevent influenza we were to have another pandemic. People knew across boundaries, having to pick oceans, we had the opportunity to Work Together around the Ebola Outbreak in africa, can you talk a bit about the evolution and development of a number bola vaccine . Back in the 2014 outbreak in west africa, during that time, we in a variety of other institutes including the cdc and other agencies began to test the vaccine which is now ultimately made by the company, merck. We had studies here in the u. S. And on campus, then we did it in west africa. We advanced phase two, we did one in liberia and ultimately it was shown in a ring vaccination study in guinea to the effective in preventing infection, particularly those exposed. That vaccine has not been used in the democratic republicans oh congo, 245,000 doses have been given in the vaccination approach. Its very clear that if we didnt have that vaccine, we would be in a much worse situation than we found ourselves in the congo. As you know from the reports coming out from the cdc, the number of cases have gone down and down. We are not through yet, its still there but the vaccine has played a major role in being able to prevent the explosion we saw in west africa. Thank you for your service to our country, vaccines are safe, effective and vaccines save lives. S. Thank you. I am grateful to the chair for holding this hearing. Fluea shots can play a very Important Role in protecting the public from the flu and reducing its spread. I want to focusea my comments oa 90yearold policy which should have ended decades ago. Why do we still have mercury fillings of flu vaccines given to infants, toddlers and pregnant women . In july 1999, Public Health Service Manufacturers agreed that thimerosal containing vaccines should be removed as soon as possible. I have a number of documents i include. E to a bibliography of studies on safety concerns about thimerosal which is vaccine grade mercury. They outline the misconceptions about mercury in vaccines, clearing up misconceptions. Th1999 statement of the American Academy of pediatrics and u. S. Public Health Service calling for the immediate removal of mercury from all vaccines. In 2004, institute of medicine recommended removing mercury from all vaccines administered to pregnant women and children. By 2003, mercury was removed from vaccines in the u. S. Yet, a year later, the cdc recommended the flu vaccine for children six months to 36 months of age and refused estate presence of mercury in vaccines. Thus, reintroducing mercury to the childhood vaccine schedule. In 2006, california passed a law saying mccurry caning containing vaccines, 2009 the credit of johnson will introduce banning mercury from power plants and even more than factory, its a neurotoxin. Even at low levels, mercury can have an Adverse Health effect particularly on women of childbearing age and developing fetuses. Youve worked with my predecessor and i reviewed your testimony from october 5, 2004. During the hearing, cdc direct director, the fda doctor, you all agreed we are removing rapidly thimerosal free vaccines. If you can move to vaccine preparation, thats riskfree with regard to mercury, you should do that. The public says is still there. Babies, unborn and newborn are in a critical stage of neurodevelopment. The one change is when the flu vaccine became a recommended shot. Manufacturers were automatically protected from all liability and accountability via lawsuits. Now they have no incentive to remove mercury. The flu vaccine packages says its not been tested for safety and pregnant women. Common sense said we should err on the side ofid safety. You testified to that 15 years ago. To completely remove mercury and takes a backseat. The steps are being taken, the Public Health community to move to mercury free vaccines. Or is it no longer a priority and when can we expect it to be completed . I dont think i can answer directly the question of when it will be completed, getting back to the discussions we had yearsw ago in the committee, i said then and i would say it again, the optimal situation would be itto have thimerosal free vacc vaccines, mostly as i mentioned that hearing, which you didnt say was that was mostly for the peace of mind of the people but the Scientific Evidence that is a harmful amount of this material in the vaccine does not indicate that. The issue with the thimerosal and ill let him comment on that, with regard to the cdc, it is in very, very few vaccines and only in multidose components and the multidose component, the balance of the risk of getting a contamination of a bacteria, which we know can occur if you dont put Something Like thimerosal in the vaccine versus the risk of the effect, thimerosal which is really ethyl mercury clearly balances to make sure you are protected from the virus, multidose viral. Its important to know the cdc is committed to assuring vaccines in the u. S. Are safe. Currently, this year is projected to be 169 million doses and we understand only about 15 of that has thimerosal. Would like to m have a thimerosl free vaccine, the vast majority of vaccines is available on the prefilled syringes, the single dose vials. A quick question, he raised a couple of issues. Is the flu vaccine safe for pregnant women . Yes. Is the flu vaccine safe for infants and children . Yes. Yes. I like to recognize the chairman from california. A neighbor from california. In care. I think the witnesses this morning, how can data science better with microbiologists to accelerate research . Biology is a discipline that impacts on virtually all biological issues so we can do biology when we do a sequencing of various strains of virus that come in and if you want to make a vaccine, he mentioned the fact that the capability both the cdc and nih to do mass sequencing of a variety of species or any virus including influenza, relies on biology to be able to get to the next step in developing vaccines. Its not a particle significant in any way . Its a display of multiple components of the stem, creates the ability to engage we call the repertoire of the immune system so the chances of it hitting the pizza that was ultimately responding to give you the time of the response, its a highly immunogenic response. Its really the wave of the arere and thats what we trying to do to get away from the situation of having to grow a complete virus and use that as the vaccine. Here, you have Dna Technology and show the immune system on only part of the virus you want to respond to. You avoid all other distracting immune responses. Thats why the Scientific Community is so excited about those new technologies. If we find ourselves in a pandemic outbreak, with existing technology, how can vaccines produced to catch up with the outbreak . An example i think is in 2017 when what there was the identification of age seven and nine influenza virus that circulated among poultry in china that ended up having almost 2000 human cases exposed to them. We were able to receive the vaccine sequence directly from china and with that, we were able to reverse to build the vaccine virus, cdc has the capability to do that under good practices and be able to hand back vaccine virus to the manufacturers. We can do that quickly within a matter of days to weeks. Once we hand it off to the manufacturers, they are bound by the existing manufacture capabilities that they have by 18 . The rest is egg basedic manufacturing which takes at least sixix months. Getting things to be quicker will be important for us to be able to respond more quickly. Can you address the autoimmune reaction to influenza vaccines . There have been an association of crossreactivity between some of the antigenic components of vaccines and certain tissues in the body. This is not clearly proven yet but in one of the Vaccines Available for the h1n1 blue of 2009, there was the suggestion that one of the peptides associated, which is part of a protein associated with the vaccine induced a response that cross reacts with a substance, called hypo cretin which is one of the neural peptides involved in narcolepsy. The autoimmune phenomenon event has been discussed, disputed but not really definitively proven. When you expose the body to a protein, it recognizes it as something similar to within your body and makes an auto immune response. My son had a pretty scary reaction to his second dpt injection. Can you speak to that, seizures . May be not dangerous but scared the hell out of us. Caesars is a knownwn reaction to a number of different vaccines. That is possible. Is it dangerous . No. Its not a a lasting impact. Okay, thank you. Thank you, mr. Chairman. We appreciate the witnesses be here. My first question deals with in your testimony, you mentioned the development of a mobile minivan, cloud based platform that can be set in her remark remote area and in the data, and analysis and action so could you elaborate on how this cloud based platform would allow Public Health officials to address the outbreak quicker and more effectively and in a larger rural area like my area in indiana . Referring to the micro technologies which actually is a sequencer, you take the specimen and prepare in little boxes we take that fit into a carry on on a plane, you prepare and simply inject it. Theres a way you can do whats called barcoding, multiple specimens at one time and with that, you get a sequence which sells you the genes so this is something we demonstrated in different settings. We did take it to iowa, a spine fair where we swabbed them and we were able to quickly do determine they had influenza circulating among the group. That plugs into a laptop through this usb port and it runs a lot of information and prepares the signal to the p cloud where we have a process called irma. Pipeline tool that takesoo the data and uses machines during Artificial Intelligence to try to determine which of the flu viruses are in the sequences and get pulled down by the staff at cdc where they can generate a vaccine virus. This allows us to take the tool to the place where the problem is occurring rather than having to figure out how to get viruses to the cdc. You can regionalized wherever you collected your data and develop a vaccine specific for that area. The manufacturing process is probably not but yes, you can tailor what you know about in certain regions. I think youll probably get into some of the data issues and testimony. You mentioned pigs and i have a backyard in agriculture so when you are swabbing those pics, any thoughts on the african swine fever works. Its Something Different than the swine influenza. So im not an expert in swine fever but technologies can be used anywhere in the world to do that kind of detection. You have any thoughts on that . The point he made in some respects, glad you brought that up. We constantly get people confused between african swine fever andca influenza in pigs tt can recombine by influenza to give us the pandemic, it has nothing to do with that but sometimes people get confused when they hear african swine fever which is unrelated to influenza. I appreciate that, thats part of the reason i asked that. Thank you. Back to the nanoparticles, universal influenza. Talk about the nature of the nanoparticles and how you bond the sections. Its interesting, the beauty of nature, a self assembling particle, a protein from a bacteria. When you combine the genes of both, when they express themselves as a nanoparticles whichh symmetrically has the stm they just fit properly. Its almost like a miracle of artural selection. Nanoparticles is just a larger protein. The stem section is highly preserved but not absolutely preserved so are you then going to need several versions or other dozens of versions in terms of the stem . We dont know but we believe we will not need very much because even though its not completely done, we dont believe the mutation that occurred in the stem have a functional relevance in making it different from one to the other. I think weve done so far were we looked at the stem, and we just recently used experiments, when you have multiple components of the stem and hughes them to screen the entire group of the group one which contains ten of those ages and it just neutralized everyone. We think that if we get a series of antibodies against multiple components of the stem, we could probably not count an entire group and there are two major groups. I think we will need at least two but i dont think we will need ten. You mentioned this is in phase one Clinical Trials. Is it proven effective in animals . Yes. Is safety what we showed in animals is that when you injected into the animal, youve got a complete array of antibodies against the flu. You dont challenge them but you know you have a protective level of antibodies. Changing the subject a bit, can you say about the rates of vaccinations within immigrants, the demonization of immigrant communities. Ways to protect the community as a form of increasing faxing confidence, certainly there are communities that dont value the faxing so a better way to get to them is to identify the factors that are leading them not to get vaccinated. Following the 2016 election, i talked tos principles in communities in my district who are turning kids away from school because they are not being immunized because they are terrified that ice would come get them if they got their kids immunized. They are u. S. Citizens but they have someone in their family who might be undocumented. Do you monitor the rates of non immunizations in different populations . I dont know if we have the information. There is coverage implicated by terms of immigrant communities, i dont know that we have that information. Get back to that, i would appreciate that. You mentioned it was the Meat Industry and various farms that was a major part of spreading pandemics. In the world where you have artificial vegetable based meat, which is one that a lot of people dream about, is that something lets was prone to pandemics . Influenza viruses are in reservoirs so humans, it circulates among humans but the biggest reservoir is among birds. Ducks and geese thats not something anyone wants. I would be very difficult to reveal. I yield my two seconds. One of the great challenges are migratory birds and animals. They move around from canada to central south america, they are the think we are most frightened about because in their flight, they deposit little presence as they go along. They are subject to consumption by other forms of life. So thats an issue. Maybe thats the best place to leave it. [laughter] thank you for all your work. Im a somewhat new product, 19 monthold son. The flu with respect to our children is something near and dear to my heart and in this room and across the country. According to wall street journal, over 27000 children four and younger hospitalized with a virus, 118 died in the flu season. Clearly these are troubling for any parent and the uncertainty more than anything. While immunization levels are relatively high, providers can do more to increase immunization rates among their patients and colleagues. Your the 70 Healthcare Providers receive the influenza vaccine each year. Through a number of different studies, they have identified one way to get patient vaccinated is to make sure the Healthcare Providers are promoting the vaccine as well. If you look at the coverage among Healthcare Providers, it falls into different categories into the more are likely to be vaccinated as a helper provided, 90 in the party further away you get from care facility, those are the ones not being vaccinated. We clearly want to get the message out to those folks to get vaccinated. In the last decade, fewer than 50 of americans actually get the shot. What research has been done to get a sense of why folks arent actually getting vaccinated . Identify root causes here. There are focus groups testing to try to find out what the reasons are. The main reason we have identified is the effectiveness of the vaccine. People dont think its as effective as it should be if its keeping them from getting vaccinated. We know there are more places to get vaccines and ever so access is one things that may have been a problem. The department of universal vaccines and highlighted in the research in their goal, in your testimony you highlight that a challenge facing that goal is improving vaccine production strategies. Could you tell us about plans to address and keep working toward universal vaccines . Thank you. That was the point i was trying to make, we need to switch into vaccine platforms, not to require to decide on a string in february and take six in the havent to seven months to get it grown and processed whereas if you get the platform such as nano particle whichf is one of several platforms, as a plan, articulated in their is to develop and perfect various platforms so we can get away fre burden of having to grow the virus. Thank you. I yield my remaining time. Thank you so much for this panel. We heard a little bit today that despite strong efforts involving the sector that the universal flu vaccine remains elusive, what advantages do you see on the horizon to improve the flu vaccine . I believe that scientific advances willl be what i was showing on one of the slides of ultimately being able to develop a vaccine that would induce a response that would have brought coverage. I was just speaking to one of the scientists whog made a breakthrough discovery yesterday when he visited the clinic in 2009, he developed an antibody from a person who was infected with the flu and found clearly to a particular component which was interesting. Then he found out that not only did itan neutralize the virus tt the person was infected with, it neutralized all of the viruses in that particular group, which is the group one. That was the scientific breakthrough that allowed us to go to the next step so its breakthroughs like that that i predict over the next few years will make it easier to get to the ultimate goal of the universal flu vaccine. In terms of the near term kinds of things people have been looking at, this is the main problem right now, one of the components, we can only push for different components and one is called h3 and two, that is the problem of a vaccine. We know when you put it into manufacture, it ends up changing that virus so it no longer, the use is the effectiveness of the vaccine. The cell based vaccine may be quicker and make the vaccine to be more like the edge three circulating. Played a role in terms of the tools being developed to modern the effectiveness. E we can expand some but to get information how the vaccine is working better or worse with age groups certain parts of the country gives us more information how to make the current vaccines better. In your testimony you mention Public Health infrastructure is a little outdated you have to prevent outbreaks before they occur it also hinders our ability so can you speak im sorry im so eager for watkins. [laughter] but if one of you could talk about the Data Infrastructure and we will pay note to him when they arrive. Over time we have seen through Electronic Health relation. But the Public Health is to receive information from different sources and theres not a standardized that the information can come in. Its hard to get the information that they need to know if this is the case of whatever from a perspective we currently get from a number of different sources, only about half of that is realtime and doctors filling out forms if we are able to get realtime information from all of those providers regularly we would be able to know what has happened at a much more global and more actionable data. Thank you. It is the race and data. Thank you, mr. Chairman i yield back the remainder of mynd time. I appreciate your attorney appeared every expert testimony. I just wanted to ask you first, what are some of the emerging technologies developed to identify different pathogens, targets of delivery of vaccines. To answer questions like this to have a markup on a differentst floor, the same building i just came in, im a dentist in one of my colleagues asked me too eliminate cavities and what i being against those and i said ges of course but we encourage halloween and things like that. [laughter] with regard to the diagnosis, im not going to address the cavity issue but in terms of diagnostics to think all the resources in an online storefront the all the Public Health department in 143 lavatories around the globe are able to go one and standard agents that cbc makes because we know the globe is doing the same testing so we can use the information quickly. That has a process called tcr with a Chain Reaction which is a common way for currently updating lack for newer pcr devices and whats really been Game Changing is the ability to establish three National Reference centers at three Public Health labs in the United States where they do all the testing so we can pick up emerging antiviral resistance and viruses that can be pandemic, those things so it can act quickly. Thank you much. That is very fascinating. What are the main scientific technological hurdles that stand in the way of the development of a universal influenza vaccine. I caught the tail end, how are you working to overcome these. Certainly, ill let doctor talk about the various different hurdles, the influence of virus has immunity forever. You can get influenza every year, the task we have at hand is very difficult and that the virus itself the body is not able to have immunity so were trying to find something in the body itself is not very good at. If you would just go ahead and elaborate as well. There is one hurdle that is really a serious hurdle, even if we have a universal vaccine that would induce a response against a wide array of influencer, thats a phenomenon that is interesting, its called imprinting and what it is, your body tends to make a response against the first influenza or antigen that it was exposed to when you were a youngster. So even later on in life when you get exposed to the organism again from an evolutionary standpoint, that was a good thing because that means your immune system is primed so if you see the micro began you make a good response. That is great for Something Like measles where mumps or rubella which does not change, is stays the same, with employing the works against you so what you will do im in h1n1 person 100 i was born at a time when h1n1 was around. So my immune system is primed to make a response against h1n1. If i get exposed to an h3 into or vaccinated with that even though all make a reasonable response, my body will revert to want to making a reverse to h1n1. Its referred to as original antigenic. , how do you gethe around that d overcome the tendency to make a responsese against something tht you were originally exposed to. That will be in important obstacle. That was the question i was saving for you and you mostly answered it. Thats why measles, rock under mumps and rubella have a 95 effectiveness where influenza is only 10 . That was a very bad year. What 60 . 40 to 60 . That is the biggest hurdle that we have. Thats the biggest hurdle that we have. They give her much i yield back. I want to recognize mr. Kasten. Thank you, mr. Chair. Thank you both so much, im totally intrigued by this universal vaccine idea in the field just humor me as a biology nerd, i want to follow, the fact esat the stim has been so preserved, how confident are you thats because theres something fundamentally that the bug cannot change the protein versus the fact that statistically the androgens were on the surface and as we start developing to go to the stim, are you confident it will evolve into Something Else . It could involve pressure but from the standpoint of conserved components of proteins, when something is concerned throughout evolution, it is usually because it is critical for that particular thing to survive whether is species of an animal or a protein, there must be something about that stem that is absolutely critical to the function of the virus. So we think it is not going to change but we better be careful, we do not want to make an assumption that will turn out to be wrong. Has the Animal Studies been of Long Duration to give you confidence that there is no, to be honest we have nott done it for a decade and shown over a period of time, if you keep vaccinating an animal in against themonse in years later it evolves, we have not proven that yet. We obviously need time. What if anything can we do to accelerate, the wheat on the side of the room to accelerate the development of the universal vaccine, as is the time to get trials . Two we thankfully have gone very good support from the congress to do the kind of work that were doing for the universal flu vaccine, and the last super creation there was a setaside that was put in order toyo stimulate the research in the area. So were very appreciative of the congress and what you already are doing. I want to pivot, im going to take a chance because i get the sense that we may share a o sene of humor. Do you know what you call alternative medicine when it works . Medicine. I raise that because were at a moment where there is a rise in antiscientific thinking from climate funds to the interfax movement to the new yorker last week had an article about the horizon and people who think where the stars were when they were born has an impact on the future. As you think about the concerns to Public Health there is one set of concerns that people consciously choosing not to take proven medicine. There is a separate risk of people who are taking bogus medicine. Which of those, are those comparable concerns and are we doing enough to combat both . I think they are comparable. I think theres danger in both of those, i think you brought up two very important points, there really is an obvious concern about people who arempan antisce and dont want to believe the clearcut science facts and there is a danger to actually having effects of assuming the efficacy of things that are bogus and going ahead and doing that. We have, several years ago, established first a center in owen institute for alternative and complementary medicine to look at these things that society of people in the community, whether they do or do not work so we are doing something about trying to put scientific rigor to some of these things that can potentially be bogus. Thats what were trying to do on that and, on the antiscience and the only thing that we can doons to continue to do what doctor and his colleagues at the cdc and what we do at nih is to continue to try to get out the message and the evidencebased proof of what works, there is nothing like evidence to be able to convince someone that something works. You have to keep coming in with evidence over and over again. Are we doing enough to keep bogus science offtheshelf, because when i go to walmart and i looked down at the flu vaccins homeopathy up there as well and i dont know the average person knows the difference. Should we be doing more asou society, there is much t the nih and the cdc can do but clearly there is stuff out there that really does not do anything but potentially harm people. Thank you i yield back my time. We reckon is mr. Murphy. Thank you, mr. Chairman. Thank you professionally to both you gentlemen. I followed your career since the early 80s and he made such a fantastic and landmark discovery woulwith hiv thats put forward something manageables today. I want to speak and figure out which questions folks have already asked, let me go back, my colleague pointed out the antiscientific movement and i think thats a major problem, i saw last week that people are starting back on thenota flat eh agenda. I want to go back to the Antivaccine Movement that is going back in our country, i wonder if you could speak to that and what its done as far as population at risk, and where you see that going in the future. It is a major issue these days. Certainly i think there are pockets where individuals are talking to one another, some schools where folks are actually hearing from each other rather to see with the science based is or listen to physicians. Those pockets can lead to more children not getting vaccinated for school. I think its important to also ogcognize that people get the information in multiple different ways. For us to be noble on how it is that we get the science based information in the evidencebased information to those folks to identify their needs and provide information that they need. But until you address those specific groups with information that is valid it can be very difficult. Thank you. One other issue i like to revisit is a ebola. I dont think people understood what had happened if that wouldve gotten into any of the other places in the future. I was wondering if you could talk about the vaccine of ebola, does it mutate on the level that the other ones do and for edification can you explain to folks the infectivity rate of the ebola virus versus hiv virus for example. I know on a multiple scale is more effective than an example would be helpful. Ebola unlike influenza which drifts is pretty stable, its an rna virus so theres always mutations but the mutations have not proven to be functionally relevant. So if you do a sequence of ebola in a strain and west africa which was the ebola and drc, there are different types but within the one were dealing with right now, it really has not been a problem that has mutated to the point of being functionally relevant. So you can major point mutations but they dont change anything about it. I think the question you asked, what is the relationship with the vaccine. The relationship with the vaccine is that the vaccine has worked in any change in the virus has not had any impact on the vaccine. So it looks pretty good. I mentioned earlier in the testimony we now distributed 250,000 vaccinations in the outbreak of the drc. The second part of your question, the issue of how its transmitted in an untreated, an vaccinated arena such as whats going on in the drc, that is the mortality of about 67 70 which is transmitted only by direct contact with the contaminated bodily fluid. That was really important. So someone gets ebola and incubating it and get a fever but not having diarrhea or bleeding or vomiting, that person is really quite noncontagious and thats a reason why there was not concern of people back when the patients in texas got infected, it was a concern that the nurses were infecting people and they were not. When you get influenza, influenza is transmitted by the respiratory route, there iss a window of when youre actually not very sick and you can transmit it because youre shedding virus for a period of time before you know. There is a substantial difference inal transmissibilit, it is tough to get infected with ebola unless you have direct contact with a really sick person whereas you can get influenza on an elevator when the person next to you sneezes. Thank you ill yield back the remainder myai time. Thank you gentlemen for yielding. I would like to add one word document. It clearly indicates that while these vaccinations are safe for most people, there are some for whom its not safe, the trust fund has paid out 4 billion which they did not mention, 46 of those were for influenza based vaccinations. So i did not want to ruin the love in here but i think we should not be cavalier about those that we do try and identify whom it might not be appropriate to receive the shots for Public Safety in the future. Thank you very much. Thank you doctor chairman and doctor for reminding us that we can get the flu in elevators which we write in all the time in this building and im glad i got my flu shot. Thank you to the witnesses for being herek today. To reflect over what happened last century, we made an astounding success developing vaccines to eradicate diseases in the United States. We have eliminated polio and smallpox and wisteria and the rest of the world, largely defeated those and vaccines have prevented 10 Million Deaths between 2010 and 2015, thats remarkable. But in this hearing were acknowledging there is a great deal of work to do especially with i influenza one of the most pervasive Infectious Disease globally. Yet despite the effort we are still struggling to effectively predict or respond to those epidemics because of the rapidly changing nature of the flu. The news the exciting cuttingedge research being conducted through out the country to develop new approaches, thank you doctor for bringing your model and thank you doctor for bringing your mobile lab. A lot of that work is federally owned or supported which is why am glad were having this hearing today, some of that research is happened at the university of portland and doctor jonas and his team are working on a novel method of longterm flu vaccination the insert target pathogens into mega virus to atrigger a response are you familiar with this approach, can you briefly explain how it differs in methods in different breakthroughs. Are you familiar as will question my. The person youre referring to is doctor lewis and he has established a vaccine platform which is highly immunogenic, is called a victor platform, he takes a virus that we know and have experience with, he inserts into the virus the gene of a particular protein that he wants to make, he started with tuberculosis, hes done with hiv and other pathogens. What happens, if you want to make a vaccine which is trying to do against hiv, he takes the gene to the outer protein of the hiv called the envelope and sticks it into the mega virus and he injects it first into an animal, he has not done into a human yet because there were safety issues, it is not a benign virus so it needs to get scrutiny from the fda and the animals its been very effective. They injected into the animals and it replicates in pumping out this protein which is the hiv protein and hes created in the animals a pretty good hiv vaccine. The project i was mentioning was the Health Science university institute. In oregon. Also, i wanted to ask about the flu site website, since 2013 the cdc has engaged in predictive analytics, how is that working in the Public Safety website, what are you learning from that . This is a network where we have over 25 different epidemic modelers that use varies different sources of information, social media, whether all kinds of different information. We provide them input each week and they have to tell us what they think is going to happen in terms of the flu will peak this week, when it will start et cetera. Its the way we try to get not whats happening with the flu now but what is it going to do. We think thats important so when we have a pandemic we can use that information to inform folks but during regular seasons of that information can be helpful for an Outpatient Clinic knowing when they need to increase the amount of staff for hospital and have more beds in the icu. Even for pharmacies to know. Doctor, the data from 100 countries which you determine viruses are recommended for inclusion in annual vaccine, what challenges exist with collaborating with so many countries and make sure that suitable and what can be done to improve the International Disease surveillance and data sharing so we can better prepare. We have very good view of what is happening within points with thousands of viruses that we characterize. We work with 143 other laboratories who sees viruses from them but theres blank spot we dont know what is going on. The more we can get improved surveillance in that setting, more timely information that helps that country and the rest of us to know what is going on in north pandemics are showing up and make better vaccine. Let me recognize ms. Laxton. Thank you mr. Chairman and thank you doctor for joining us here today. In october the cdc released new statistics about maternal vaccination. I was kinda surprised to see the only one and three pregnant women receive both flu and whipping cough vaccine. Because women with the flu are more than twice as likely to be hospitalized in pregnant and nearly 70 of whipping cough occur in children younger than two month ofy age. However, flu vaccinations during pregnancy reduced hospitalization less than 6monthold by an average of 72 and whipping cough will lower the hospitalization of babies by 91 . I think we can agree that vaccinations are a no go part of prenatal care for expectant mothers. Iy understand that doctor you mentioned in your testimony fewer than half of adults in the United States will get the flu shot because they have a perception that the flu vaccine is not effective. I know you talked about misperceptions and false information out there how can we more effectively communicate the benefits of flu vaccine . With regard to pregnant woman, i think its currently around half are getting vaccinated for flu, that actually is a real success story, over the last several years weve seen a rise and clearly we need to do more and do more with the other vaccines for pregnantwi women. If you look at whos getting vaccinated, only half of americans are getting vaccinated you can see the most are happening among the old and the very young. So trying to get at the groups late in the teens, 18 49 years of age is a group we need to get to increase the amount of vaccinations. That will take targeted efforts using social media and other approaches to get to them. It then used to getting a vaccine every year and annual think. Yet to get a vaccine every year for the flu and thats a group of people that dont bill themselves of a lot off preventive healthcare and dont go to the doctor a lot. Getting that group is a challenge but one we need to work on. Im glad you brought up social media, we have seen a lot of how social media can impact lives in a good way or a bad way. One of the issues with social media is that information spreads so quickly, the viral nature allows people to communicate ins a bubble withot external sources that point out when something is plain false or something is true and withstood pure review and all of that. It is something we have seen across committees and other contacts as well but here in this issue were talking about lives at stake. The American Academy of pediatrics at letters to the ceo of social media platforms including google, facebook and pinterest and highlighted the growing harm to children from vaccine mix information spread across their sites. I understand you spoken and some of your testimony about the misinformation and how it spreads. This is for both witnesses, you think these platforms are doing enough giving lives are on the line . I certainly think people access the e information in different ways than they used to. So making sure we get our information evidencebased in the format that is going to be reusable in that setting is an important thing. I dont know if you want to talk more. We can do more and we can do better with the platform that we have now to get the message out are having some effect but clearly its a challenge that will not go away. We will have to keep on it, it is not going to be a problem you will solve in its over. We have to keep at it over and y over again. Thank you so much. I yield back. In closing, two other questions that come up repeatedly, folks will say its a most and of november, already made it this far i dont need a flu shot this year, is that correct . Our recommendation from the immunization practices in cdc, we recommend you get your vaccine if possible by the end of october but as long as influenza violet antivirus is circulated we recommend you get a vaccine. It is not too late to get a vaccine. Our goal is to get people vaccinated prior to the season start so there is two weeks of time before it allows the immune system to build up. But clearly we recommend you continue to get vaccinated now. Most of americas watching this and not another hearing, it is not too late to get vaccinated. Another question that comes up, nasal flu vaccine versus flu shot. In any recommendation. Cdc does not have a preference for one vaccine over another,fo their personal preferences and parental preferences in regard to the influenza enable vaccine. Theres an appropriate one over the other. Once again i want to thank both of you to your service for this country and service to madison and those watching at home, vaccines are safe, they are effective in vaccines save lives. We will recess for a few moments and allow the second panel to get seated. Thank you. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] welcome back at this time i would like to introduce our second panel of witnesses. The first witness on our second panel is doctor sharon, she is the director for the bureau of epidemiology in the state academic t knowledg epidemic knt and also counsel ofid the state and territorial epidemiology she is over the Environmental Health and Community Health preaching has led disease surveillance and operated response efforts between those related to zeke, healthcare infections means a hunter measles and hepatitis a. She has over 40 publications in 20 years of experience in appliedbl Public Health and epidemiology. Thank you for being here. Our second witness is doctor Robin Robinson. Doctor robinson is Vice President of Scientific Affairs for novacare incorporated. He served as a first director of the Biomedical Advanced Research and develop my authority. And Deputy Assistant secretary for preparedness and response for 2008 2016 pretty served as the influenza and emerging Disease Program director from 2004 2008. Doctor robinson was a recipient of the department of defense and play their award in 2008, the hhs distinguished Service Award three times in a finalist for the service to america meddle in 2009. Thank you for being here doctor robinson. As a witnesses should know you will have five minutes for your testimony, your written testimony will be included in the record for the hearing. When you have completed your spoken testimony we will begin with questions in each member will have five minutes to question the panel. We will start with doctor watkins. Ranking member lucas and members of the committee, thinking of the privilege to appear before you today, my name is doctorod sharon watkins, president of the epidemiologist see fte and state epidemiologist foria the pencil under Pennsylvania Department of health. It is an organization of 56 Member States and territories. Representing epidemiologist for disease detectives. We work everyday and partnership with cdc to detect p and respond to influenza outbreaks, gain an understanding of the changes in the virus and deliver lifesaving vaccines. I have witnessed the devastating impact of seasonal influenza. The 2009 h1n1 pandemic, measles and many other vaccine preventable diseases in the communities ide serve. Public Health Threats require efficient timely responses that rely on a network of Public Health agencies at all levels of government and coordination with Healthcare Providers, response to outbreaks happen at the age group affected an underlying status in an outbreak in a school or longterm care facility. For example they need to be rapidly identified edy upgrades. Lack of interoperability reporting consistency lead to errors of quality and timeliness and communication. I have stood before communities in crisis who are justifiably bewildered and angered Public Health cannot access disease data or faster. How is it i can log into a portal to get my test results that you are charged with protecting Public Health dont have access to todays health data corrects that shocks it talks people to learn that we dont have National Coverage with Public Health Surveillance Systems. About 40 of all visits are not submitted to public up department. The bin is flatfooted in identifying and responding to flu infections among highrisk groups included pregnant women, children and the elderly. We are now entering flu season and are challenged by the concurrent outbreak of the illness associated with ecigarettes. This health is urgentl urgentlyl records to distinguish ecigarettes related cases from flu cases. This information d arrives piecemeal through different times through different channels. Try to decipher addendum one in my written testimony. Its a fourpage sample of a 350 page medical record received by the Pennsylvania Department of health on one of the ecigarette cases. Providers already have this data shared and collected in Electronic Health records that cannot rapidly shareco these wih Public Health who have no way to receive them electronically. Death certificates are filed on paper in some states in only 63 of death certificates are submitted for national aggregation within tenat days. Regrettably, most pediatric deaths occur in unvaccinated children and it takes weeks to uncover and link the flu death with vaccination history causing logs and communication who need answers to these questions. Cft and our partners the association for Public Health laboratory together with more than 90 other institutions believe the time is now the step up and take a native approach for a 2 2021st century data highway. The superhighway will collect health data from Healthcare Providers and reported to Public Health departments and link it to other data. Including birth and death records and immunization registries ensure the dataec securely with cdc, the technology is here. Where we really need are resources for the proposed funding of 100 million included in Human Services appropriation bill to support Data Infrastructure is urgently needed. During the ongoing deliberation csd hope you will consider the need for modernized electronic and operable Public Health data system and the did Health Science to strengthen Public Health prevention and strategy vaccination. We recognize this must be funded with new money rather than cut underfunded Public Health without federal support Public Health surveillance will remain unattainable we look forward to working with you and i thank you for the opportunity to testify t today. Thank you. Doctor robinson. Igood morning. They stand for the opportunity to speak today. I am doctor Robin Robinson the Vice President of Scientific Affairs of novacare the former director barta and the developer of the vaccines in the industry. Four years ago i testified as a director before the house and state of affairs during the harsh season and what we could do to remedy mismatch flu vaccine. Since that time in influenza has returned and brought illness and death by the medicine cabinet and antivirals. They have a fourth string of influenza vaccines in a new class of antivirals were added since 2015 we have not solved the issue with influenza vaccines, poor effectiveness. Our domestic capacity to produce influenza vaccine has quadrupled since 2005 thanks to the investment in technologies. However, the ability to manufacture and makeno available pandemic vaccines are not fast enough to preempt the gnomic effects. Lastly many candidates have emerged over the past 40 years but none have crossed the finish line. Today i wish to address poor vaccine effectiveness, low vaccine elusiveness of influence of a strong and lasting immunity currently of in season virus for immunization for seasonal influenza and serve as a prima y per the story of Vaccine Developmenthe as long, for the past 40 years multiple ways it has driven universal influence so are the earliest and most expensive but in the 1980s and 90s focused on vaccines comprised the were poorly immunogenic. They target the highly conserved mp that were developed in totally in magenta counsel. The story change or two discoveries one of which they mentioned earlier, it made this decade antibodies were discovered in 2011 to specific conserved sin portion of the hemoglobin protein and divine and neutralize widely influenza viruses. This discovery has led to a new development of hemagglutinin and stem vaccine candidates undergoing evaluation presently. The discovery which occurred this year, was a finding of antibodies conserved epitopes on the immunities protein which is been a target for antivirals for many years. These f antibodies neutralized widely diverse influenza viruses, it will initiate another wave vaccines as scientists will include this specific protein in the next generation of flu vaccine candidates. On the issue of more rapid production of influenza vaccines, a new synthetic Vaccine Technology may expedite vaccine production. Since they do not require the isolation adoption and production of viral vaccines of current still based vaccines, weeks or months may be saved in production. This timesaving may allow seasonal influenza vaccine strains when mh mass occurs between circulating viruses. Similarly the production time for 600 million doses up endemic vaccine they be reduced from six months to three months and become available before the pandemic peaks. As vaccines may be a faster way to distribute and administer these vaccines many vaccines are encapsulated in nanoparticles as doctor stated in which they have properties in the ability to administer vaccines, trans a syringe and a needle for selfadministered patch. None of these innovations and discoveries will make it to the influenza vaccine unde without R Partnership your continued wisdom, generosity and support have carried us this far. Help us finish the journey. Thank you. Thank you doctor robinson. At this point we will begin our first run of questions, the chair recognizes himself or five minutes. Doctor robinson, thank you for your service at barta, i had the chance to talk with them about barta but another organization i had a chance to meet with, an organization that is looking at bringing International Community together, along with the private sector to look at vaccines for emerging diseases, if you could elaborate a little bit more on the mission and what the big disappointment the United States does not participate in i be curious about your opinion as to whether the u. S. Should participate in if you want to elaborate on that. [inaudible] can you share in your market run. Sorry. Thank you for the question. I always smile when thats brought up because my former deputy at barta who is richard who is the current ceo there. Should u. S. Participate in the activities against emerging Infectious Disease and development of vaccines, the answer is, we already are. This was with the inception of sapi occurred back in 2014 and it became a reality into thousands of it too. The nih embargo specifically had investments in emerging Infectious Disease and vaccine such as ebola, zika and others. That was part of a contribution, we would continue, the u. S. Government effort in these specific areas. So we do actually support what they do and in many cases we had contracts that are supporting the same projects that were working on without duplication of exactly what theyre doing. If we play off of that for a moment and might interest in some of the threats, if we look at emerging diseases and some of those pandemic threats, what is our capacity within the private sector to quickly ramp up if we see in emerging pathogen and quickly identify it a potential back under vaccine to medicate the pathogen. Just from your perspective. I will give it in the context of when i started my Public Service in 2004 which would take months or years to respond to a new pathogen. My first assignment was influenza virus and how we can make a vaccine towards that. Since that time we had a real life testim in 2013 with the emergence of h5n1 in one virus which would take seven months to produce as a vaccine, we brought that down to the three months, specific reason why, firstlo you heard, we were able to get the sequence of that virus immediately and it was on april fools days of 2015 and moved forward within weeks to have the sequence distributed not only to the vaccinebu manufacturers but also for economy. By the summer we had those vaccines in Clinical Trials. In record time we were able to do that. The innovations we are talking aboutt. Today would even expedie that further. Our goal is to have a pandemic of vaccines not only produced but available in 12 weeks. Doctor watkins, in a prior life i received a lot of Public Health work and make chuckles because we would get information faxed to us and most of the public would not believe that in this day and age in 2019 a lot of Public Health records and information is factbased. So you talk about interoperability and collecting data and crating big data sets. Can you elaborate a little bit more on what that will allow you to do in terms of more rapidly identifying potential breaks et cetera and why a more robust and operable Electronic Medical record or an electronic Public Health record would allow you to do your job better . Sure, when i think about medical delivery of the Healthcare System today, it is amazing, the advancements that have been made. I think Public Health has been left behind a little bit. We are still dealing with fax and phone calls and spreadsheets and it really does impact our ability to quickly respond to ay situation. So immunization records are able to bee i quickly linked to our electronic disease reporting system, if we are able to get an electronic case report and see data as itspo coming in and digested in the health departmentar we would be able to respond much faster, much of what we do in many of the pandemics or emerging threats that we have today is scratch our heads and were struggling with the data sharing in the Data Management of so much big data. Public health needs to have our systems renewed and reinvested and cst has produced in conjunction a lot of stakeholder stories and this that talk about why Public Health and the time is now to invest money in her data system. The chair now recognizes the Ranking Member for five minutes. Thank you, mr. Chair. Doctor robinson in your testimony you highlight Clinical Trials showing vaccines are stockpiled and remain highly effective even after ten years of storage, how does barta work with industry to improve shelflifee of stockpile vaccines in the event of a pandemic emergency. Thank you for the question. We started in 2005 building stockpiles for pandemic influence to treat those individuals that are highly vulnerable, highrisk and critical workforce to make sure the countries to operate in the severe pandemic. Around 27 million doses. That was actually for all the different strains that had been shown to pandemic from the age seven and one i described a moment ago toed new waves of age seven and why virus, through the process with barter, fda and nih, we meet twice a year, go over the strings to see which ones are available but in 2015 we said in the question came up from the members here, the vaccine that you have stockpiled in these companies, is it still good . And the answer was, we know it looks really good but thats not enough. So we went and did a Clinical Study using newly made viruses vaccine against a vaccine that had been made ten years before in the results of that which have been published show they were equal. They were still highly immunogenic and could be used without or with two predictors individuals. Thank you doctor. Doctor watkins you suggest Artificial Intelligence Machine Learning could be useful tool to identify outbreaks early and encourage individuals to get vaccinated. Can you elaborate further how it can be utilized. Sure, thank you for the question. Public health does have a lot of data, is not interconnected, i think the ability to look at birth and death certificates and immunization rateser in existing and combine that with behavior information and informational poverty in immigration status, all of those data sets help us understand the community level, why the hesitation or the limitations to vaccination or access to healthcare or maybe language barriers. When we are able to use all the data that google has at their hands that we dont. I think were better able to target where efforts should go, as an example during the Opioid Crisis we andhe other states funded by cdc have been looking at vulnerability assessments. So were looking where are deaths happening, where are babies being born with neonatal syndrome, where our hepatitis c and hiv increasing, where does the overlay with poverty and other statistics. That is use of big data to look at vulnerability and target where we should be working. We could do that with many more things if we have the technology and interconnection. Thank you doctor, i go back. We will recognize doctor murphy. Thank you, mr. Chairman. Thank you for coming this afternoon and i appreciate your expertise. A question i will have for doctor watkins, i was looking through the copies that you have a medical records and having experienced the explosion of the Electronic Medical record in the last 25 years i see the25 challenges, if you could wave a magic wand, there is a way to pull data out of these reports and quantify it, what would it look like. I preface it by saying we have so many different medical record systems in our country most of which dont talk to one another. Unless we have literally a single system, i am notte sure what this will look like. Im interested in your thoughts about reality, how we do this because i think the purpose altogether is great but the devils in the details, what does that look like. Thank you for the question i would also refer you to this report that has been done and we can get you a copy of that. But what were talking about is modernizing systems we already have, our Laboratory System which is called limbs and ability to rapidly transmit data between us and the provider and cdc and handle those genetic results needs to be modernized and make more interoperable. Our death and birth certificate registries need to be more rampant. We should not be having paper records of these important documents. Our immunization registry should be interconnected with other disease reports. Our electronic disease Collection System should be able to know if youve gotten influenza in a death certificate comes in. I should not have to wait weeks, i should be able to see that within realtime so looking at being able to bring those in and cdc is doing a lot of work on electronic case records and modernizingat of all of the systems, what we talk about is bringing all states up to a better level, some states are really far behind in summer behind in some things but not in others. When i think about pandemic for the next emerging issue, were Public Health to protect your family, my family and the Publics Health with the same Tools Private medicine has in the same speed. That is what were talking about. Thank you for the question, its a daunting task. I think its a good idea and i will tell you it adds an entire additional level of data entry but then again thats what we do, we work on data. Wed like to get out of the data entry. I have analogies for you if i may, to me it is like im sure we all have private positions, we have Healthcare Providers and they are not sharing information, handwritten on you, they are not walking in Lab Test Results in a spreadsheet. They are working in a modern world with modern technology and Public Health is the front line for pandemics. We should be working with the same speed. Its like building a space probe and forgetting to put in the advanced communication and data sharing aspect. I feel like in this world of healthcare and vaccine innovation, were thinking about that but we need to think about modernization of Public Health data sharing so we can be the front line of Public Health and not be the week link of the chain. I agree. Those are the issues, its not cancer or other things that you need connectivity. One other quick question, if you could speak we talked a little bit about the vaccines that come from eggs versus the cell based. Can you speak to why you do not believe the technology of the latter is taken up or are we making Good Progress towardog moving away from the eggbased vaccine . Because of the efforts we had a hhs and barta we made a paradigm shift where we were 100 eggbased to 85 . How are we going to move to at least having greater adoption of cellbased when we dont have the problems with mismatched . First of all we have to realize the influenza vaccine industry is a commodity driven industry. The way they were able to move the needles to begin with was interacting in a public partnership. That has to be revived to continue to go forward with the new discoveries to make it worthwhile to have a product so they can get out of the eggbased vaccine business. I will say, there is promising progress that companies that are slowly eggbased have been bought with candidates. In their actually license now or internally developing new influenza vaccinene candidates. We need to expedite that and facilitated with the continued effort that weve had before. One followup, do you think doing that is regulatory or is it the economy of the cost. Its not regulatory. The industry and part of the industry will say we dont want to do that because we had to go through the entire process of getting a new vaccine like the fda. But thats the normal course of Vaccine Development. The real problem is why spend money when we do not have to print that is reality. Thank you very much. I yield back my time. Let me recognize mr. Cohen. Thank you, mr. Chair. Doctor robinson, you touched on the first panel, but the whole public media, social media conspiracy theories about vaccinations causing autism, how much of an effect has this had on people getting vaccinated and how much of an effect of people not getting vaccinated doesnt have a Public Health. So to support that question, the first part how much what was the effect of antivaccine groups for autism. We fought this battle during the last decade and i will say to a great extent, that battle has been one. In the Scientific Data was shown that there is no link between vaccination and autism. The second part of that. Let me ask you a followup, you say it has been one,. Im going to into that, we have a new wave of antivaccination. Im very concerned aboutm this. Because they dont have as their true agenda vaccination. They can care less whether it works or doesnt work because they have a hidden agenda for other things of anarchy and other things and the tactics that they are using are ones that cyber terrorists have been using over the past several cyber terrorists have been using the past several years. Im very alarmed. m the roots of vaccination is not the real issue here. My friend Robert Kennedy junior, hes a major anti effexor. Hes not for anarchy. I think his issue was thinking that mercury is a preservative was the cause. Is that correct . Thats one of the platforms. Has there been studies to show its wrong . What we have said earlier, mercury in some virus of some vaccines, we made an effort in 2008 with the influenza vaccine to remove that and manufacturers did that without being mandated to do so. There are single dose syringes without mercury in those vaccines and they are primarily given to children and pregnant women. Major progress on that, his testimony earlier that the cdc are mounting efforts to minimize that. The t amount and kind of mercury are not the kind that mr. Kennedy has talked about. Do you have perspective on this asct well . I think public help is worried about the sentiments and we need to do a better job on the efficacy and benefits in addition to preventing and lessens the severity and complications. Particularly for those to prevent death and hospitalizations. I think Public Health thinks about the fact that where the people get the help information and how they communicate with each other, we need to do a bettero job producing, convincg messages that are shared on different platforms. How many people die annually from the flu . I dont have a figure in my head but we can get that. At the low end, 10000, upwards of 40000 a year. So those more likely than not, if they have the flu vaccine, not that particular strain but that would have been reduced greatly if all those people had been inoculated . Correct. Thank you. I have a big proponent of vaccinations, my father was a pediatrician gave vaccines. Ein 1954, he gave vaccines to second grade students and test trials. Had a brother second grade. I was in can garden, he brought it home to give to me. He had second thoughts because i was outside discharge. Within two months, i got polio. Vaccines are good. I healed back my time. We will have additional questions from members and ill start by recognizing myself. Y doctor watkins, weve been having conversations with completes like google and i know google has been doing some work in identifying particular search words that may pop up i would allow us to rapidly say people are searching the term fever or try to quickly go into countries in africa or someplace, are you familiar with this and have they been successful or not . Public health is aware of those crowd sourcing tools that look at g. I. Symptoms are fever but weve not been using them in Public Health, i think they ha have. What we are interested in because we are a system that uses case based surveillance, we are counting you as an individual. But we have extended past that into surveillance where we are looking at the identified Emergency Department visits and gaining information that way. I cant say whether google has been validated through Public Health message but i can say looking at Emergency Departments are seeing a spike and its been incredibly effective not just in identifying the uptick of fluke but of many other diseases including being able to identify clusters of illnesses. Do you want to add anything . I still think its worth, as we look at Global Health and pandemics too continue to work with these technology companies, because part of rapidly responding in getting ahead of pandemics is quickly saying look, lets identify what that pathogen is an see if we can mitigate it. With all due respect, i think Public Health is under sourced and under resourced so our ability to do that is contingent on being able to modernized. Public Health Information systems speak across state lines . Not necessarily, no. Not because of any regulatory issues weve placed,to thats under resourcing or ohio doesnt have the jurisdiction to see john smith in pennsylvania has influenza. Its my jurisdiction. We could do a better job of sharing not identifying it and when theres an outbreak and we need to share the information, we do so securely. But no, for example in my state, philadelphia is on a different Surveillance System and it doesnt really matter. We have to work hard to share data in the cdc wants to see statewide data, we have to work with philadelphia to harmonize it. Let me ask another question about vaccination rates. When i was a child, i got a lot of my vaccines at school. It always occurred to me that for efficiencies sake, especially for multidose vaccines, youve got to have kids going there, the overhead, if you have schoolbased nurses to go intobl the schools and vaccinate kids, it would be more effective, more efficient and id be curious about something we made a mistake of moving away from. We do school based vaccinations and outbreak settings, we use that venue. I think schoolbased nursesnk ae a resource that is shrinking and schools have access to that. I think looping schools into immunization and other issues is always a call of Public Health. Weve done it broader and have shrunk that footprint. I understand liabilitync isss but from from the efficacy perspective,ct i think the investments in Public Health nurses or schoolbased nurses, the overhead etc. And the efficiency particularly with multidose vaccines, you lose a lot of kids who dont come in for that. I believe you can rapidly boost the number of children getting vaccinated if we were to utilize tools like that. I have one more question in regards to measles, id be curious from your perspective, is a Public Health professional, how pennsylvania and others are trying to address the outbreaks. We are exhausted. I was just at a conference with new york and i cant even imagine what theyve had to go through to address those thousands of cases. In pennsylvania, we are at 17 cases i think. What you dont realize is that for every case, hundreds of people are likely exposed. If they been in close contact and exposure, if you were inspected with measles right now, everyone in this room and ttwo hours after you left it would have been exposed. Public health, we track you down. We assess your immunity. We work to make sure not only are you taking care of but everyone youve exposed is notifiedu and properly treated. Re either immune or not if w cant get prophylaxis in time, you may be quarantined. There are a lot of steps that go into measles. Its an enormous resource strain. Its been difficult for any of us who have had cases of measles. S. Thank you for your work and all the Public Health professionals. Thank you for coming. We are looking at this in one level the problems you face, my question is, what have you done in pennsylvania to talk to the other counties because Public Health departments are run by counties, what have you done on the state level to develop productivity box i did a lot of work in the legislature with opioids, we have people on the board going to virginia getting prescriptions and vice a versa so we worked close back with our state neighbors to develop a system that somebody in virginia would know if they arere crossig the line to get prescriptions in North Carolina. Its the same thing, not necessarily a federal pushed on, we look at the nations whole of whats going on. These tend to be localized. So what have you done on the state level . Pennsylvania is structured differently than North Carolina. We have ten county and municipal jurisdictions so they are on our same system of disease surveillance so we are able tond share that. What happens to our lab reports, and,d, report comes in and we ph it to the jurisdiction. Or district office. Mostly, if youre in a whole system, if youre in pittsburgh, pittsburgh has their own records. But we do collect it all in the same data system. Philadelphia is large and they areo able to have their own in a different system. We work with them in a disease perspective and share information all the time. Work with them from an it perspective to try to harmonize what we do. Iv we are always working withou our neighbors whether its a hepatitis a outbreak or measles or sharing, patients dont have orders. You can be hospitalized in new jersey and go into a longterm care facility in pennsylvania. So we keep in touch but we can do it better, faster and without misinformation if we are better electronically. If are you not electronically suited and why would you not appeal to your state to make that happen . What im talking about is the sharing of laboratory information, disease surveillance and thats happening at the state level but its not an easy connection. Weve not invested money in this in a long time. Our immunization record is not connected to our disease surveillance record. Im speaking from a national perspective. I could be answering for many states. I dont know if your immunization record in North Carolina is connected to your disease registry. For many states, its not. Those are the things that would help us get a response faster. Measles exposure situation, whos been immunized . Thats a hard question. It shouldnt be but it is. Weve resorted to going to high schools, who stored records and look them up because the physician has gone out of practice or Public Health is a make it work kind of system. We do what we need to do but getting further and further behind. In the success weve seen with cancer, the hpv virus, where are we, where you see us as far as other malignancy vaccines . I dont see the door being knocked down. Suzie that briefly. Twenty years ago i was in the industry, we worked on a Prostate Cancer vaccine. What has driven the oncology vaccine has been planted by the antibodies that have been developed with Great Success in the last 15 years. Thats somewhat moving the vaccine programs, especially with companies to a lesser degree. Wereof the vaccines extremely promising as we and others are evaluating the clinic. I suspect once we reach the peak of the antibodies for oncology purposes, we will see a resurgence of vaccines for different types of cancer reappear probably in the next decade. Thank you. Before we bring the hearing to are close, hard to think our witnesses for testifying today. The record will remain open for two weeks for additional statements from members and additional questions including maps of the witnesses and the hearing is now adjourned. All. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] during this thanksgiving week, featuring tv programs that you will seek we can see on cspan2. Tonight at 8 00 p. M. Eastern, memoirs with jack talking about his stepfather. Robert wilson retells the life of the cofounder of the bailey circus. Lucas on urban policy after world war ii. Book tv tonight here on cspan2. Tulsa oklahoma. Thank you for taking my call. Its the one network that President Trump did not criticize. The one network that opens to the speaker just before me and myself i will state as a democrat, 77 counties in 2016, voted trump. Theres evidence in what i have seen, without commentary from anchors, there needs to be a trial in the senate. But the process work itself out. If hes not guilty, but it work itself out. Administrations response on cspan, cspan, your unfiltered view of the impeachment inquiry. Hearings continued next week as the House Judiciary Committee talks with constitutional scholars. The committee will take recommendations from Intelligent Committee and they want to hear about constitutional grants for president ial impeachment. They invited President Trump and his Legal Counsel to attend and ask questions. Will be live on cspan. Org, listen live on the free radio app. Cspan follow candidates cory booker as he spoke with New Hampshire voters at a house party, brewery and coffee shop in the southern part of the state in between two of the campaign. He called New Hampshires representatives. Down to the right. We have a bunch of members and their. Our short speech. Is okay . Yeah