Committee hearing is about two and a half hours. This hearing will come to order and without objection the chair is authorized to declare recess at any time. The worlds population killing approximately 300 Million People in the 20th century alone. Smallpox is the only human disease to be eradicated thanks to the development of the vaccine. Another devastating disease, polio just started a third case worldwide in 2018 compared to 350,000 cases in 1988. Everyday vaccines are saving lives. There is no such thing as healthy skepticism when it comes to vaccines. There is a wellfunded Disinformation Campaign targeting the public and weakening the publichealth law. School vaccination requirements have been commonplace in the u. S. Generations and exemptions were granted for legitimate political reasons. However in my home state of texas, the number of unvaccinated children who spiked since 2003 when they expanded the exemptions to include non medical reasons. The 57,000 last year we are seeing this played out across the country and innocent children are falling ill. Health officials have confirmed 21 cases in texas this year and 1261 nationwide. 61 of which lead to serious complications. The Science Committee may not have jurisdiction over the agencies but we have long had a role in supporting Public Health through good science and we would explore the integration challenges for Vaccine Development through the lens of influenza for the healthiest among us it leaves us out for several days with no lasting side effects. However, for the young and the elderly, it can be dead late. The center for Disease Control estimated 48. 8 melian illnesses and 79,000 deaths during the 2017, 2018 flu season. The each year influenza vaccine production begins with a collection analysis of data many months before the beginning of the season. The challenge with influenza is that the viruses change constantly and by the time the season begins, the vaccine may not match the circulating viruses. Scientists are working to develop alternatives as well as a vaccine that will not require annual updates. Another many are incomplete. Incomplete data in the system through modernization of the systems the data analytical tools across the federal and state levels we will be able to accelerate the Vaccine Research and development for many diseases. We have two expert panels that will help us understand from basic research to Vaccine Development, production and deployment and surveillance. The witnesses will also describe the role of federal agents and the private sector including the part worships among all of the stakeholders. I want to extend a warm welcome to all of you this morning and think the vice chair for his leadership on this issue. I look forward to todays discussion and i might say i have a mark upon another committee so i will have to leave before we get through all of the deliberations. The chair will now recognize you for an opening statement. Id like to thank you for holding this hearing especially given that we are in the middle of flu season. Nearly a million individuals are hospitalized every year including more than 48,000 children. In oklahoma since the 2019 flu season beyond, theres been one death and 73 hospitalizations. However, these numbers would be worse if we didnt have vaccines. Vaccination is by far the best measure we can have today to. Its easy to forget a little over 100 years ago the world faced one of the deadliest pandemics and history the 1918 h. One and one epidemic that has thasthe spanish flu that killedn estimated medical technologies at the time were limited to isolation and. The influenza vaccines did not exist and antibiotics havent been fully developed yet. Thankfully due to basic research, advancements were made in treatment and prevention. The development played an Important Role in reducing and eliminating deadly disease. I can still recall my fathers stories about how late summer and fall are terrifying times as a child because of the threat of polio. Luckily for me i didnt have to experience this fear because of the first polio vaccine available in the United States in 1955. And thanks to widespread vaccinations its been nearly eradicated in the United States with just 33 cases reported in 2018. However, it remains a threat in some countries with the world becoming more attractive for moderconnected throughmodern try takes one traveler with polio to bring the disease into the United States. And as im sure we will hear this morning from the witnesses, the best way to keep the United States polio free is to maintain high immunity for vaccinations. Considerable advancements have been made in the technology disease surveillance, medical care, medicines, drugs, vaccines and pandemic planning. While significant progress has been made i, the gaps remain in the severe pandemic could still be devastating to the global population. If the population has grown, so has the livestock and poultry population to feed them. This expanded number of host provides increasing opportunities for the viruses from birds, cattle and pigs to spread and infect people and as a member i supported the creation of the National Animal vaccination and veterinarian countermeasures which was included in the last farm bill. For a Rapid Response to an animal disease outbreak. An outbreak if it were to occur and we were not prepared on the entire sector suffer immense losses causing longterm harm to the economic viability of the United States livestock in swine production come not to mention the damage to human health. I look forward to hearing from Witnesses Today about the current state of the stockpile of the Human Vaccines to provide the capacity for Rapid Response to emergency situations. I particularly look forward to hearing how the influenza vaccine managing infrastructure is supporting the Public Private partnerships with domestic manufacturers to increase preparedness levels and response capacities for potential events in the United States. Last i would like to say how pleased i am to see the recent executive order to address modernizing flu vaccines. The order recognizes it as a Public Health and National Security priority with the potential to inflict harm on the United States and largescale illness and death. Most importantly it establishes a National Task force to explore alternative vaccine production methods and technologies including a plan to accelerate the development of universal flu vaccines. I look forward to seeing what recommendations come from the task force and i would like to thank the chairman for holding this hearing and also both witness panels for taking the time to share your expertise, insight with us this morning and i will yield back the balance of my time. Thank you very much. If there are members who wish to submit additional statements at this time i will introduce the witnesses. First is doctor Daniel Jernigan for the National Center for immunization and respiratory 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 of influenza. They are responsible for national and global surveillance as the World Health Organization corroborated center for the surveillance epidemiology control. Doctor jernigan entered the cdc and 94 and is a retired captain of the Public Health service and was the recipient of the 29 Teams Service 2019 service. The next witness on the panel is doctor anthony of the institute of allergy and Infectious Diseases, a position he has held since 1984. He oversees Extensive Research and applied research to prevent, diagnose and treat established Infectious Diseases such as hiv, respiratory infections, tuberculosis and ball area as well as emerging diseases. He also supports research on the transportation transplantation and related illnesses including antiindian disorders asthma and allergies. He has advised six president s on hiv aids and many other domestic and Global Health issues. He was one of the principal architects of the emergency plan for aids relief, a program that has saved millions of lives throughout the developing world. As our witnesses should no, you will each have five minutes for your spoken testimony. Your written testimony will be included for the hearing. When you have completed your testimony, we will begin with the question. Each member will have five minutes to question the panel. Well start with doctor jernigan. Thank you very much and good morning chairman lucas and distinguished members of the committee. I am the directors of the influenza position at the center of Disease Control and prevention i want to thank the committee for the opportunity to discuss the work supporting vaccine innovations to improve the prevention of influenza. Each year influenza causes a Significant Health burden with many millions of americans becoming ill, hundreds of thousands requiring hospitalization and tens of thousands dying. They are constantly changing requiring us to update the components every year. Sometimes these changes can be sudden and significant resulting in those that can lead to devastating pandemics. Hospitalization deaths can happen in any season and each year the vaccination prevents millions of illnesses and thousands of severe sometimes tragic outcomes. Influenza vaccines are very safe and remained the single best way for people to fight the flu. Despite the significant benefits, the effectiveness of those are not optimal. We are working with nih and other federal and State Government partners and private sector to use cuttingedge science to make vaccines that are. The longlasting broadly protected universal vaccine will talk about are the ultimate goal for the flu prevention. However, vaccines are still years away. In the near term we can save millions of americans by making incremental improvements to the vaccines that can be produced using already available production platforms and getting more americans vaccinated each flu season. The cdc has a central role in every part of the development and administration cycle including continuous virus tracking around the globe, preparation of the vaccine viruses, purchasing 10 of the vaccines used in the United States and monitoring the safety and effectiveness. To improve, theyve implemented innovations throughout the vaccine lifecycle. The cdc has invested in and collaborated with every state Publichealth Department on surveillance. This has resulted in automated realtime Electronic Laboratory reporting of test results using cloudbased messaging. To characterize all of the specimens received this means we can identify and track the virus is much more quickly and accurately leading to more timely connection and earlier detection of the viruses with pandemic potential. The genomic sequencing equipment at once filled a room now fits in the palm of your hand. We now have a mobile mini lab that can be taken on the plane as they carry on and can be set up anywhere in the world including resource constrained settings. The cdc has implemented innovations for supporting vaccines by developing vaccine viruses for the cellbased vaccine and by providing genomic sequences used to make the protein vaccine. Both of these have the potential to be manufactured more quickly and may be more effective than those that are grown in neighbors. They also now routinely generate a vaccine viruses using a technique called reverse genetics. This allows us to build the vaccine in a matter of days or weeks making the u. S. For quickly to respond. The cbc was the first to establish a National System for the protein monitoring the and thats effectiveness provides critical information for the manufacturers and researchers in developing enhanced vaccines by collecting more specific data about how low the vaccine works each season. Recently weve expanded the network and we are planning to add new testing and conduct more studies to better evaluate the effectiveness. Finally a major component of improving the vaccine impact is getting more people vaccinated. Fewer than half received their influenza vaccines and despite all of our success and leadership there is still more we need to be able to do. Each of the topics i mentioned today from working with domestic partners to tracking the viruses to the candidates into studying the vaccine effectiveness will benefit from investments in generating more precise and timely data. I believe we can harness this to make vaccines work better. I want to close today by reminding you all to make sure that 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 your questions. Thank you very much madam chair and members of the committee thank you for giving me the opportunity to testify before you today. I am the director of the National Institute of allergy and Infectious Diseases and im going to talk to you over the next couple of minutes about the efforts to improve the influenza vaccine and develop a universal flu vaccine. As shown on the slide although as it is mentioned its important to be vaccinated because even if it isnt 100 effective or even 50 effective, the benefit. We can do better because the influenza vaccines are not consistently optimally effective. We know through history that the pandemics occur but we are usually tothey areusually too le as we were in the 2009 and finally we spend considerable time chasing after these as we had with the significant investments we needed to do that, but they never occurred. My colleague and i gave the introduction emphasizing the point i just made a it would lead to a better capability to respond to the pandemic influenza but ultimately get us to the goal we will speak about in a minute or two and that is the development of the influenza vaccine. In the summer of 2017, we put a group together to develop a plan that we published in 2018 for the Strategic Planning and Research Agenda to mobilize scientists throughout the country into th and the world tp a universal flu vaccine. So let me explain what we mean by universal flu vaccine. This is somewhat of a complicated slide but it does make the point. We will not get a universal flu vaccine overnight. It will be a statewide process in which we go from improvement in the broad capability of responding to a particular type strain versus the ability to respond to all of the strains. Note on the lower lefthand part of the slide is divided into two major groups. Group one and group two. On the righthand part of the slide, the tip of the triangle is what we do today. We make the vaccine for this season that is highly specific to the strains circulating this season however, those change. So then until we have a universal vaccine that essentially covers all of these. We are going to do that with new technologies as you are well aware. Youre well aware. We currently have a technique of developing a vaccine although thats tried and true and timehonored its inefficient and has many areas of going wrong so we are using new platforms as it is shown here on the slide such as proteins, viral vectors, nanoparticles and others. This is a blowup of the influenza virus into to the right is an important protein called the keynote was nick. Its important to note it has two components. The head is the part that the body makes them immune response but it often changes leading to the ineffectiveness. However, the dark blue is the stem doesnt change much at all so the strategy now, one of several strategies is to develop a vaccine in which you cut that off and put it on a narrow particle that will ultimately serve as the vaccine so if i can show you this, this is a 4 million times a blowup of what the first universal flu vaccine would look like and these dark blue areas are the stems. We have slaughtered a phase one trial as it is shown here in the spring of this year. It will end at the end of this year and then next year we will do a group to universal flu vaccine. So as the president said in the executive order, the purpose of what we are doing is to go ahead and improve little by little until we get the vaccines to protect us in the most efficient way possible. Thank you. At this point we will begin the first round of questions and the chair will recognize herself for five minutes. The campaign has different populations with different systems and innocent children are falling ill today with diseases that we once thought were eradicated in the u. S. Young women are being put at increased risk for cancer and these task forces are creating the major challenges due to the vaccination efforts. How big of a role does the social media play in this resurgence and how can we overlook the need to overcome these tactics and what are they doing specifically to combat these efforts . One of the reasons why they dont get vaccinated is they are worried about the effectiveness of vaccines with regards to the discussion here, improving the effectiveness of the vaccine certainly would get more people vaccinated. The question is around the role of the misinformation and social media participating in that. We do think that theres a lot of information out there. Couldnt have lots of different places they can get information and a lot of times they dont know which of its sciencebased evidencebased. For the trust by truly trying to get people to be more confident in the vaccines getting information out there about how effective they are and if it comes down to three things, protecting the communities helping to understand the differences in the different pockets between the communities and wont make them dont have so much confidence in the vaccines as they should and to identify the materials they use for the specific communities. The second thing would be to empower the parents to get them the right information to understand about the benefits of the vaccines and understand why its so important to get vaccinated and work with clinicians so they have the tools to talk with those family members as well and then finally to stop as much as possible we do that by providing the scientificbased evidencebased information thats out there on the website and then working to make sure that can be reused on multiple different platforms for people to better sciencebased r evidencebased information. If you do a survey and find out why people dont get vaccinated for influenza, its because of the socalled misperception that it really doesnt work and i think we need to emphasize that even if it isnt 100 effective, even a modestly effective vaccine will protect you from getting infected or prevent individuals particularly those who are susceptible to this perception we need to put that aside the state department of health reported that the party claimed onauthorityclaimed one life in l lives and the others. Continuing on the comments that you have made, when i look my constituents in the i got home to stress the importance of getting vaccinated and two prevent the hospitalizations could you expand on that if youre in a meeting with me this is oklahoma, you were talking about things that are to the point they occur because of influenza. There are tens of millions of cases every year hundreds of millions of hospitalizations and tens of thousands of deaths every year. We know with the vaccine we have weakened the event of thousands every year and tens of thousands of hot polarization. Its important to get vaccinated and not just for your souls so helps protect the Community Around you. Its like something you should take every year to keep you from getting a second heart attack so people with underlining conditions that helps them as well. It protects pregnant women and their babies. Getting a pregnant mother vaccinated helps the baby until they can get vaccinated. Other data shows it is like sitting in children. You can reduce the chance of influenza by 65 . Even if it isnt 100 effective with mentioned, it can reduce the severity that you have during the flu season if you were to get infected. My background as an agriculture we have the veterinary stockpile which is prepared to provide farmers and ranchers with a swine flu within 24 hours, could you speak to the current state of the Human Vaccine stockpile management and what we can do to better prepare to address the potential pandemic . I would love to do that. The folks back home are paying attention that is you and your entities are taking care of their best interest. In terms of what we do at the cbc, we monitor influenza around the globe especially the Avian Influenza and the swine influenza around the globe. We do that through the laboratories and we would detect those and take that information and use it in a thing called the influenza Risk Assessment tool. You can see the graphics where we have ranked concerning the potential pandemic viruses. With that information we work with the inner agency to determine which of those could be made into vaccine candidates and which ones should undergo trials and so with that weve made decisions about things to put in the stockpile its important for us to find new vaccine technologies so that the vaccine stockpile isnt something that just has to keep getting more and more vaccines put into it. In my final moments before i yield back in my Opening Statements to my fathers observations in the 40s and 50s prior to the development of the polio vaccine and 55, healthy else breaks to seemingly getting worse and worse and the sheer terror that it brought into the community in the early fall. My generation was not a life for that and didnt experience that but it was truly terrifying. My first job when i was 14 is running a country cemetery and i had a great and this was a family historian and i remember asking why in one section of the cemetery where all thes why aree babies. The coffee is young women, she said that the tombstone. 1918 and 1919. The spanish flu took them all and brought even in rural oklahoma for society to a grinding halt for the week since the. Of my generation having not experienced any of that sometimes doesnt necessarily understand what the potential downside is and why all of you work so hard. Thank you for giving us this opportunity to focus on these issues and with that i will yield back. Thank you to the Ranking Member for allowing me to be a doctor today and there are a couple of hearings happening today i think that this is the most important taking place and thats why all the cameras are out. Your home district in my home state, we are on the frontlines for some of the misinformation thats out there. A couple of quick yes or no questions. Absolutely not. When i was practicing ive talked to some of my patient is. They would often come back at me and say i dont want to get the flu vaccine because i had it before and it causes the flu. Is there any evidence of the flu vaccine causing the flu . Th the flu vaccine does not cause the flu. I think its important for us to dispel some of these myths. There are legitimate reasons for the small covert individuals if they have allergies to eggs etc. , to opt out of the vaccine. Its important with used needles as an example of the concept of herd immunity and i think its important for the public to understand that particular concept. Its a very important concept not only for the flu, but the recent unfortunate experience that we had particularly new york city in the williamsburg section of the classic example of what happens when the umbrella of herd immunity goes down below a certain level because you have a community in which it was somewhere between 70 to 80 for measles you need somewhere between 91 and 93 or more of the community so that when someone inevitably comes in from the outside you get the unfortunate situation that we saw in the williamsburg section. What are the current vaccination rights in america . Over 90 . So we want to keep up. That. And measles both the disease that for the most part we have eradicated in america and now we are starting to see that, the incidencome ofthe incident is sp up again. Doctor jernigan, i will often hear individuals stay we dont really need these vaccines because we havent had a pandemic like this for 100 yea years. Can you talk a little bit about why we have been so lucky . With the pandemic influenza is a situation where the flu viruses are actually circulating in animals and can actually mix with those viruses that are in humans and when they do that, they share their genes and can create a flu virus that hasnt been seen before. That means it can spread very quickly through the community and often caused severe deaths and illnesses of hospitalizations. 1918 as it was mentioned as one of the worst and about one clearly caused at least probably 675,000 deaths in the United States. Weve had three other pandemics in the last 100 years and those were changes that were not as bad. We at the cdc have looked at the 1918 virus and found that there are particular changes in the virus donated severe, so there is nothing to prevent that from happening again so for us it is important to maintain the vigilance so that we can see what is happening. Maintain the ability to have the Vaccines Available quickly so that we can get it and be able to prevent influenza and severe influenza if we were to have another pandemic. And in our connected world when we know people across boundaries were having to two bg oceans are not necessarily protected. You and i have the opportunity to Work Together around about 2014 Ebola Outbreak in west africa. Can you talk a little bit about the evolution into the development oand development ofd us in the 2017 outbreak and congo and given us the ability to better manage . Back ibackend dot 2014 to 16 outbreak in west africa during that period of time, we together with a variety of agencies including the cdc and other International Agencies began the testing of a vaccine that now is ultimately made by the company merck, said at the time we did phase one studies right here in the United States we did it at the nih in our campus, some were done in europe and then we did it in west africa. The advanced to phase two. They did a study in sierra leone and we did one in liberia and then ultimately it was shown in the vaccination study in guinea to be effective at preventing infections particularly those who were exposed. That vaccine has now been used in the Democratic Republic Of The Congo in over 245,000 doses have been given in the contact ring 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 a Democratic Republic Of The Congo. And as you well know from reports coming out from the cdc, the number of cases. The vaccine has played a major role in being able to prevent the explosion that we saw in west africa. Thank you for your service to the country. Just in closing, vaccines are safe and effective and save lives. So, with the fact thank you. I am grateful to the chair for holding this hearing. Flu shots can play a very Important Role protecting the public from the flu and reducing its spread. I want to focus my comments on a 90yearold policy that should have ended decades ago. Why do we still have mercury in millions of the flu vaccines that are given to infants, toddlers and pregnant women. In july, 1999 the Public Health service, the American Academy of pediatrics and vaccine manufacturers issued a joint statement agreeing that aerosol containing vaccines should be removed as soon as possible. And at this point i have a number of documents i would like to include in the record by unanimous consent. First is a bibliography of studies raising safety concerns about the vaccine mercury. Second, the report from the Childrens Health offense offens outlining some of the misconceptions about mercury axioms for clearing up some of the misconceptions. Third, 1999 b. And statement of the academy of pediatrics and u. S. Public Health Service calling for the immediate removal of mercury from all vaccine. In 2004 the institute of medicine recommended removing mercury from all vaccines administered to pregnant women and children. By 2003, mercury was removed from vaccines in the United States. Yet a year later the cdc recommended the flu vaccine for children six months to 36 months of age but refused to state a preference for mercury free vaccines. Thus reintroducing mercury to the childhood vaccine schedule. In 2006 california passed a law banning mercury containing vaccines for pregnant women and children three. In 2009, much to the credit of the chairwoman johnson called the bill was introduced banning mercury from power plants, and i think that what she said then is even more pertinent to the vaccinations that it is a neurotoxin even at low levels it can have an Adverse Health effects, particularly on women of childbearing age and on developing fetuses. You worked with my predecessor doctor weldon and i refute your testimony from october 5, 2004. The hearing was on removing it from flu vaccine. During that hearing, the cdc director, the fda doctor and you all agreed and stated repeatedly we are removing rapidly, we are moving rapidly to remove to commit to the aerosol free vaccines it also said that the better part is if you can move to a vaccine preparation that is absolutely risk free with regards to mercury then you should do it. The public concerns are still there. It is in fact a toxin. Babies, unborn and newborn are at a critical stage of the neurodevelopment. Manufacturermanufacturers were d from the liability and accountability by the lawsuits. For the flu vaccine each one says that it hasnt been tested for safety and pregnant women. Common sense said that we should air on the side of safety. You testified that 15 years ago. To completely remove it from the fear takes a backseat each. Which steps were being taken to wayne is expected to be completed flex i dont think i can answer directly the question of when it can be completed getting back to the discussions that we had years ago in the committee. I said then and i would say it again the optimal situation would be to have the same aerosol free vaccines. Mostly as a mentioned in the hearing but you didnt say was mostly for the peace of mind that is a harmful amount of this material and it doesnt indicate that. The issue with the same thimerosal. The balance of the risk of getting the contamination of a bacteria, which we know can occur if you dont put some thing like thimerosal into the vaccine versus the risk of a deleterious effect clearly balances the favorite of makingg sure youre protected from infections and the multidose viral. Maybe you could amplify that a bit. Event. I think that its important to note they are committed to ensuring the vaccines in the United States are safe. This year is projected to be about 169 million doses of the vaccine and we understand only about 15 of that is the thimerosal containing multidose vials. So those that would like to have this thimerosal free vaccines and the vast majority is available is the pre filled syringes, the single dose vials. My time is expired. Thank you. Before i recognized them, just one quick question. Youve raised a couple of issues and may be is it safe for pregnant women . Yes, absolutely. Is the flu vaccines safe for infants and children . Yes. With that i would like to recognize the german from california. The gentleman from california. How can occupation will be the science partner better with microbiologists to accelerate the research . Computational biology is a discipline that essentially impacts on virtually all of the biological issues we do so we can do computational biology when we do these sequencing was of the various strains of the viruses that come in and we do want to make a vaccine for it. I contacted Opening Statements, he mentioned the fact that the capability both in the cdc and the nih to do mass sequencing of a variety of any virus including influenza relies on computational biology to be able to get to the next step in developing a vaccine. The symmetry pattern is if nanoparticles significant in any way . This i mean actually what it is is the display of multiple components of the stem create the ability to engage what we call to be so repertoire of the immune system so that the chances of it hitting the cells that would ultimately respond to give you the kind of an antibody response that you want, that is a highly immunogenic approach into the nano particle approaches for any vaccine is really the wave of the future. And that is what we are trying to do to get away from the situation of having to row a complete virus and use that as a vaccine the way we are doing and it was. Here you use the Dna Technology and show the immune system only that part of the virus that you want it to respond to and avoid all of the other distracting and human responses. Thats why the Scientific Community is so excited about the new technologies. Thank you. Doctor jernigan, following up on the cluster and if we find ourselves in a pandemic outbreak, how quickly with existing technology and the vaccines be produced to catch up with the outbreak . In the examplan example i th7 when there was the identification of a very bad influenza virus that started to circulate among poultry in china and ended up having almost 2,000 human cases exposed to them. We were able to receive the vaccine sequence directly from colleagues in china and with that we were able to use reverse genetics like i mentioned before to actually build the vaccine virus. Of the cdc has the capability to do that under the laboratory practices, conditions at the cdc and then be able to hand the vaccine virus back to the manufacturers. We can do that very quickly within a matter of days to weeks. However, once we hand it off to the manufacturers, they are bound by the existing Manufacturing Capabilities that they have. About 18 of all manufacturing right now is in the non eggbased manufacturing. The rest is eggbased manufacturing which takes at least six months and so getting things to be quicker is going to be an important National Security thing for us to be able to respond more quickly. Thank you. Can you address the autoimmune reaction to influenza vaccines and forget my pronunciation such as speed to there has been a rare association of crossreactivity between some of the antigenic components of the vaccine and certain tissues in the body. There was, again, and this hasnt been clearly proven yet but in one of the vaccines that was available for the flu in 2009, there was the suggestion that one of the peptides that is associated, which is part of a protein, that was associated with the vaccine induced the response of cross reactive with the substance i hat idea to e these big words, but the substance called tycho crater in which is one of the peptides that is involved in the narcolepsy so the autoimmune phenomenon of that has been discussed and disputed not really definitively proven so what is is tha it is is that whu expose the body to the protein, it recognizes it as something similar to what is in your body thinks an autoimmune response to it. My son had a pretty scary reaction to his second injection. Can you speak to that . It was a seizure that was pretty scary maybe not dangerous but scared the hell out of us. Certainly. Seizures is an unknown reaction. I dont know the particulars but it is possible. Is a dangerous . Know, for the most part it isnt something that has a lasting impact. Thank you. I will yield back. Thank you mr. Chairman. We appreciate the witnesses being here sharing your expertise. So, my first question jernigan, deals with in your testimony you mentioned the development of a mobile minilab, cloudbased platform that can be set in a remote resource setting to process test virus specimens and to send that data up to the cloud for further analysis and action. So, could you elaborate on how this cloudbased platform would allow Public Health officials to address the outbreaks quicker and more effectively in the largely rural areas like my Congressional District in indiana . Yes, we were referring to the use of these micro technologies like this one here which actually is a sequencer so you take the specimen and prepare it in some little boxes that we take that fit into the kerry on on a plane. You prepare them and simply injechave simplyinjected them ia way that you can do bar coding of the specimen data to multiple specimens at one time. With that, you get a sequence and it tells you the gene of the influenza virus. So this is something we have demonstrated in various settings and we did take it to iowa to a swine affair where we actually swallowed a number of show pigs that were able to quickly determine if they had influenza that was circulating among the group. That data plugs into the laptop through a usb port and then on the laptop that runs a lot of the information and prepares the signal that gets sent to the cloud where we have a process called irma which is a tool from a pipeline tool that actually takes the data and uses Machine Learning and Artificial Intelligence to try to determine which of the flu viruses ar are into sequences. That information then gets pulled out by our staff of the cdc where they can than it needed to generate a vaccine virus. So, this allows us to take the tools to the place where the problem is occurring rather than having to try to figure out how to get the viruses to the cdc. To take that one step further, you could regionalize or wherever you collected your data and then you could develop a vaccine specific for that. Its possible. The manufacturing process was probably yes, you can tailor what you know in certain regions. I think that the doctor will probably get into some of the data issues and the subsequent testimonies. So, you mentioned pigs come and i have a background in agriculture, so when you were swapping those pigs, any thoughts on the african swine fever . Yes, its something that is different than the swine influenza so im not an expert in the swine fever, but certainly the same kind of technologies could be used anywhere in the world to do that kind of detention. Thank you. Do you have any thoughts on that . But i bet he made it interesting. Im glad you brought that up because we public debate coke constantly get people confused with african swine fever and influenza, but its in pigs and can combine, think of it as a pandemic but it has absolutely nothing to do with it but sometimes people get confused when they hear the word african swine fever which is really completely unrelated to influenza. And i appreciate that. Thats part of the reason that i mentioned that. Thank you and i will yield back. Thank you, mr. Chairman and thank you to the witnesses. Back to the nanoparticles universal influenza. Can you say a little the nature of the particles until you actually brought the stem sections to the particle . Its very interesting. Its a beauty of nature. Its a self assembling particle. Its a protein from a bacteria and what it does is when you combine the genes of both, when they express themselves, it is as a nanoparticles that symmetrically has to stem okay. I hate to use the word but its almost like a miracle of the natural selection. It is just a larger protein. Exactly. The entire group one and it just neutralized every one of them. We are not 100 percent sure but we think if we get a series of antibodies against multiple components we could probably knock out an entire group and there are two major groups. So we will need at least two but i think ten. Fascinating. This is in phase one Clinical Trials . That is human safety and has a been proven effective in animals quick. Yes. So it is through animals. Alicia with animals if you injected into the animal you have a complete array of antibodies against the whole panel of flu. You have a challenge but you have a protected level of antibodies. Changing the subject a little bit can you talk about the unique challenges of the immigrant populations with a have reticence to connect to anything official because of the demonization quick. Relative to my other one earlier comment to protect the community certainly there are communities that value the vaccine so to get at those groups is to identify the factors. So with immigrant communities talking to principals in my district turning kids away from school because they are not immunized because they are terrified i. C. E. Would come get them. And these are kids that are us citizens maybe they are undocumented do you monitor the rates of non immunization do you see an effect quick. And with that coverage to look at race and ethnicity. If you could get back to us i would appreciate it. Finally you mentioned that as a major player in the world where you have artificial vegetablebased meat is that something you are intrinsically less prone to pandemics quick. If virus was in the reservoir so human is a reservoir. Human specific influenza circulates among humans. The biggest is among birds like migratory waterfowl like ducks and geese. Thats not something anybody wants. That would be difficult to track. One of those gray challenges are migratory birds and animals. They move from canada to the pacific and south america that would that is what we are most frightened about because they deposit presents when they go along that is subject to consumption by livestock so that is an issue that causes us great inks to. Let me recognize mister gonzalez. Thank you for all your work program in a new father and an 18 monthold son and obviously the flu with respect to our children is near and dear to my heart. According to the wall street journal article it is estimated over 27000 children ages four and younger were hospitalized and 118 died during the 2017 and 18 flu season. Troubling for any parent and all those immunization levels are high they do still exist and providers can do more so according to the cdc fewer than 70 percent of Healthcare Providers receive the vaccine. There another study to identify to have patients vaccinated that the Healthcare Providers are promoting the vaccine as well. The more you are in an academic hospital to have upwards of 90 percent and with the repair facility those are not vaccinated but clearly want to get the message out that they need to be vaccinated. Additionally in the last decade fewer than 50 percent get the shots. Why do you get a sense they are not getting vaccinated cracks. Periodically testing is done on different groups to find out the reasons that made that we have identified is the effectiveness for co people dont think it is effective as it should be. So access couldve been a problem. And then to be highlight strategy. With the influenza vaccine. And then with the production strategies. And with the universal vaccine. But we really need to switch into different platforms not to requite to have to decide on a strain between six and a half or seven months to have grown and processed or if you do the platforms as part of the Strategic Plan is to develop and perfect the various platforms to get away from the burden of the virus. I will yield my remaining time. We heard a little bit today that despite strong efforts with the public and private sector the universal flu vaccine remains elusive so what scientific advances do you see on the horizon to improve this flu vaccine quick. And then ultimately to be able to develop a vaccine to induce a response i was just actually speaking to a scientist who made a breakthrough discovery and in 2009 to develop the anti body from a person who was infected with flu and it found a component of the stem anti body and then he found out that not only did it neutralize the virus the person was infected with but all of the viruses in that particular group of ten. That was a scientific breakthrough to allow us to go to the next step of the universal flu vaccine so breakthroughs like that make it easier to get to the ultimate universal flu vaccine. In terms of the nearterm kinds of things the main problem right now is one of the virus components one of them is called h three into that is the problem child we know that when you put into eggs it ends up changing the influenza virus much like those circulating viruses and people so using the egg based manufacturing there could be some changes on the effectiveness of the vaccine itself so moving to these vaccines could be quicker allowing it to look like the h three and two viruses. Can the government play a role in the tools that are developed to monitor the effectiveness and safety of the vaccines quick. Absolutely we have a network that we manage 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 the improvement and use of data through Healthcare Facilities with the public has to receive information from different sources right now a common way for the information to come in plus its hard for the state department to get the information that they need to i need to intervene quickly so we get realtime information from a number of different sources only half of that is realtime if we could get realtime information from all of those providers regularly we would know what a much more local level and actionable data for decisionmaking. Thank you. Yes with that data and i yield back. Thank you. Also to the gentleman for being here for your expert testimony. Doctor, what are the emerging technologies developed and identified to identify different pathogens to deliver vaccines pardon me if yorty answered questions but i have a markup on a different floor so i just came in. Im a dentist in one of my colleagues asked me if there were vaccines to eliminate cavities and would i be against those. We encourage halloween. [laughter] with regard to the diagnostics the cdc has an resource which is an online storefront of 143 laboratories around the world to have standard reagents the cdc makes for the testing of influenza to use that information quickly with the Chain Reaction thats a common way we are currently updating that but genomic sequencing to have those Public Health labs to have all of that Genomic Testing and viruses that may be pandemic that are emerging. Thank you very much. Very fascinating. One of those hurdles of the influenza vaccine how you overcome, doctor jernigan quick. Certainly. I will let dr. Fauci talk about all the different but the influenza virus can help with human immunity for ever. So the task we have at hand is very difficult the body itself cannot have longlasting. Can you just elaborate on that as well dr. Fauci quick. One hurdle i think is serious even if we get a universal vaccine that would reduce the response against a wide array of influenza it is the phenomenon called imprinting your body tends to make a response the first antigen that it was exposed to when you were a youngster so even later in life when you are exposed to that microorganism again from a revolutionary one evolutionary standpoint that is good so it is primed if you see it again you have a good response. Thats great for measles or mumps or rubella which doesnt change or stay the same but influenza works against you so what you will do with h1 and one that i was born at a time when h1 and one was around semi a system is primed to make a response against that so if i get is exposed to age three and two even with a reasonable response my body will revert to h1 and one that is referred to the original antigenics so the real problem is how do you get around that to vaccinate somebody and overcome the tendency to make the response against something you were originally exposed to. And thats the question this is why mmr vaccine have a 97 percent effectiveness where influenza is only 10 percent. Know that was a very bad yea year. Is closer to 60 percent. That is the biggest hurdle. Exactly. Thank you very much i yield back. Thank you mister chair. I am totally intrigued by the universal vaccine so as a biology nerd to follow the question that this has been so preserved how confident are you that is because there is something fundamental that you just cannot change that protein with the antigens on the surface so as we start developing antibodies are you confident it will evolve into Something Else quick. It could from evolution pressure but from conserved components conserved throughout evolution at usually because it is critical to survive whether a species of animal or a protein so there must be something that is critical to the function of the virus so we think its not going to change but we have to be careful and not make an assumption that will be wrong. Is the animal stuff of duration to give you confidence. To be honest, no. We havent done it for a decade and we show over a period of time we keep vaccinating an animal making it responsive and then years later we havent proven that yet. So what if anything can we do to accelerate these universal vaccines quick. Thankfully we have very good support from congress to do the work we are doing in fact there will ask appropriation to set aside to stimulate the research in that area so we are very appreciative to congress what you are already doing. I will take a chance that we share a sense of humor what you call alternative medicine when it works quicks . Medicine. We are add moment of rise of Climate Science denial and Anti Vaccine Movement in the rise of people who think of the stars are when they were born has an impact on their future. As you think about Public Health one of the concerns Anti Vaccine Movement consciously choosing not to do the medicine another separate of those that choose to take bogus medicine which of those baby and praising this wrong but are there comparable concerns are we doing enough to combat both quick. I think they are comparable there are danger in both you brought up two very important points there is an obvious concern of people who are anti science and there is a danger to have deleterious effects assuming the efficacy to do that. Several years ago we established the institute for complementary medicine to look at some of these things that people are convinced works whether they do or do not so we are doing something about putting scientific rigor to these potentially bogus but on the anti science and the only thing we can do is continue at the cdc and nih to get out the message and the evidencebased proof of what works theres nothing like evidence to convince someone it works you have to come in with evidence over and over. Are we doing enough to keep bogus science offtheshelf . I see flu medicine and theres homeopathy editor of the average person knows the difference so should we be doing more quick. As a society we could be im not sure that we could or the cdc could do but clearly there is stuff out there that doesnt do anything except potentially harm people. We recognize mister murphy. Professionally gentleman i have followed both of your careers with fantastic landmark discoveries with hiv now it is manageable. As the last one to speak i have to figure out what people have already asked. So pointing out the anti Scientific Movement i think thats a major problem people are now starting back on the flat earth agenda. Going back to the Anti Vaccine Movement could you speak to that what it has done for populations at risk and where do you see that going in the future . It is a major issue. Certainly there are pockets where individuals are talking with one another and schools that hear from each other so those pockets can lead to children not being vaccinated. Its important to recognize they get their information in multiple ways so for how of us we get the evidence based information for what the needs are so those specific groups it will be very difficult i would like to revisit you both i dont think people really understood the gravity what would have happened if that had gotten into any place. Does it mutate at the level the other ones do so explain the infection rate versus hiv i think that could be helpful. With ebola unlike influenza that mutates it is pretty stable there is always mutations they have not proven to be functionally relevant so those in the strain of west africa there are different tapes ebola zaire and ebola sudan the one we are dealing with right now really hasnt been a problem to be functionally relevant so you can measure but it doesnt change anything about it so the question you ask the relationship with the vaccine that any change of the virus has no change so it looks pretty good so as i mentioned earlier in the testimony the 250,000 vaccinations now the second part is the issue of how it is transmitted in the untreated on vaccinated arena like the drc the mortality that is 60 or 70 percent and is transmitted only by direct contact with the contaminated bodily fluid. That was important so if they get a fever they are not pleading or vomiting it is non contagious not a concern of people so if you get Something Like influenza and it is transmitted by the respiratory route and there is a window youre not very sick and you could shed the virus before you get sick so there is a substantial difference in transmission its tough to get infected unless you have direct contact with a really sick person you get the flu on the elevator next to you. Thank you mister chairman i will yield back. Thank you i like to add one more document. Clearly it indicates while these are safe for most people there are some for whom its not safe with a billion dollars that they did not mention 46 percent were for the influence based vaccination for quite it want to ruin the love but i should not be cavalier for those for whom it is an appropriate and we do try to identify what might not be appropriate to receive though shots. Thank you for reminding us we could get the flu in the elevator which we ride in all the time in this building. And thank you to the witnesses for being here today. Reflective of what happened last century it was antics on astounding success essentially we eliminated polio and diphtheria largely defeated those the who estimates that vaccines have prevented at least 10 Million Deaths between 2010 and 2015. In the hearing today we are acknowledging there is a great deal of work to do especially with influenza one of the most pervasive Infectious Diseases globally so we are still struggling to effectively predict those epidemics because of the rapidly changing nature but there is this exciting cuttingedge research to develop these new approaches thank you for bringing your model and your lab. Im glad thats why we are having this hearing today. Some research is happening at the university in portland and to work on a novel method of longterm vaccination with target pathogens in the cmv virus trigger a response by the t cells i dont understand what that means im hoping you can explain it but teethree are you familiar with this approach and can you explain how that differs from what you described in your testimony or more traditional antibodies are the method in search of a breakthrough quick. The person you are referring to is doctor lewis ticker and he has established a vaccine platform which uses a virus that is highly mutagenic it is called a vector platform so thats it we have experience with inserting into the virus the gene of a particular protein. He is done with tuberculosi tuberculosis, hiv and other pathogens. So what happens if he wanted to make a vaccine which he is trying to do against hiv, he takes the gene in the outer protein of the hiv and sticks it into the virus and injects it into an animal that is not a benign virus. But it is very effective. So it pumps out the protein which is the hiv protein. So at the university with Gene Therapy Institute so asking doctor jernigan we have over 25 over models that use and they have to tell us if the flu will peak the speaker when it will start its way not what it is doing now but what will it do it could be an Outpatient Clinic and then to have more beds of the icu. So data from within 100 countries to determine which virus are recommended in inclusion to see that that is usable what can be done to improve the International Disease to be better prepared it is a very good view of influenza. But there are blank spots on the globe and the more to get improved surveillance and more timely information that helps the rest of us to show up and make better vaccines. My time is expired i yield back. Thank you for joining us here today. In october the cdc released maternal vaccination i was surprised pregnant women receive the flu and whooping cough vaccine women with the flu are twice as likely to be hospitalized if pregnant and 70 percent of whooping coughs death are in children younger than two months of age. The flu vaccination during c reduces admission of babies by 60 percent whooping cough by 91 percent to help we can agree they are a critical part of prenatal care for expectant mothers. And understand that doctor jernigan and you said in your testimony half will get their flu shot because i have the perception that it is not effective i know we have talked about misperceptions and false information but how can we more effectively communicate the benefits. Regard to pregnant women it is a real Success Story you have seen it rise to that level and clearly we need to do more with the other vaccines if you look at who was vaccinated you can see its among the old and the very young. But those that are late in their teens thats when we have to start increasing the vaccination so thats where we really start to use social media. And getting the use to getting a vaccine every year. Plus its a group of people that dont avail themselves to preventative healthcare so that group is a challenge for one we need to work on. Im glad you brought up social media and how that can impact lives in a good way or bad way and one of the issues with social Media Information spreads so quickly with its viral nature allows people to miss communicate without sources that point out if something is false or is true to withstand peerreviewed. It is something we have seen across committees and other context and how lives are at stake in the American Academy of pediatrics with major social media platforms with google and interest to highlight from spread across their site and i understand you have already given your testimony about the misinformation and how it spreads. But do you think these platforms are doing enough . I think people access information in multiple ways so to make sure we get our information is scientific and evidencebased format that is reusable is important. I agree we can do more and do better but the platforms that we have now for the message has a positive effect but clearly it is a challenge that will not go away. We have to keep on is not a problem that we can solve. We have to do it over and over again. Thank you so much i yield back. Enclosing if you questions that have come up repeatedly folks will say its almost the end of november ive made it this far is that correct. Our recommendation is that we recommend you get your vaccine if possible by the end of october but as long as it is circulating we recommend you get a vaccine so it is not too late. The goal to get people vaccinated prior to the season start because there is two weeks of time prior to allow their immune systems to build up that clearly we recommend you continue to get vaccinated now. Most of america is watching this hearing right now. Not the other one. [laughter] it is not too late. Another question that comes up occasionally vaccine versus flu shot any recommendations quick. We do not have a preference for one over another there are parental preferences like the nasal vaccine there is no preference for one over the other. Once again thank you for your service to this country into medicine and for those watching at home flu shots are safe vaccines are safe and vaccines are effective and save lives. Now well will allow the second panel to be seated. Thank you. [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 is doctor watkins the director of epidemiology and the state for the Pennsylvania Department of health also president of the council of state and territorial epidemiologist and is responsible for management and oversight of the bureau of epidemiology that includes the position of Environmental Health and community health. Doctor watkins has led surveillance and efforts relating to seek a measles and hepatitis a. Has over 40 peerreviewed publications and over 20 years of experience and epidemiology. Thank you for being here. The second witness doctor Robin Robinson currently Vice President of Scientific Affairs development previously is director the biomedical or the 30 and Deputy Assistant secretary for preparedness and response 2008 through 2016. Also has Influenza Program director 2004 through 2008 doctor robinson was a recipient of department of defense award in 2008 hhs distinguished Service Award three times and a service to america award metal you will each have five minutes for your testimony the written testimony will be included in the record. When you have completed your testimony we will begin with questions each member will have five minutes to question the panel. Doctor watkins. Ranking member and members of the committee thank you for the opportunity to appear before you today im president and council of state and territorial epidemiologist for the Pennsylvania Department of health. And organization of 56 Member States and territories representing Public Health epidemiologist we work every day in partnership with cdc to respond to implement outbreaks to understand potential changes in the virus with lifesaving vaccines we have the h1 and one pandemic and measles and other preventable diseases in the communities they serve. Public Health Threats require timely responses at all levels of government in coordination with Healthcare Providers. Response to outbreaks happen at the local level. Data on the age group affected by that underlying illness and pregnancy status or a longterm care facility. They all need to be rapidly identified where to respond and what is needed but we are choked by antiquated data systems that are obsolete with. Sluggish data sharing methods for go the system is in dire need of security 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 people to learn we do not have National Coverage connecting hospitals with Public Health Surveillance Systems and 40 percent of all visits are not submitted to Public Health departments so we are flatfooted to respond to severe infections against pregnant women or children and the elderly. We are now entering flu season in the challenge by the concurrent one outbreak associated with ecigarettes we are deciphering medical records to distinguish a cigarette related cases from flu cases. This information arrives piecemeal through different channels to decipher in written testimony a fourpage sample of the 350 page record we see by the Pennsylvania Department of health. And with the Electronic Health records cannot share the data with Public Health no way receives that electronically. 63 percent of all death certificates are submitted within ten days regrettably pediatric death occurs in unvaccinated children and it takes weeks to uncover a link the vaccination history with a lack of communication with stakeholders who need answers to these questions and our partners the association for Public Health laboratories together with more than 90 other institutions believe the time is now to step up with a coordinated approach to build the Public Health superhighway to collect data from Healthcare Providers and report to the Health Department linked to birth and death records and registries to seamlessly and securely with the technology is here that we need our resources that is why the proposed funding of 100 million included in the house bill to support Data Infrastructure is urgently needed. We hope you will consider the need to modernize electronic Public Health data system and with that strategy with vaccination we recognize an effort must have new money rather than cut already underfunded areas without the support it will remain unattainable in the nation will suffer we look forward to working with you i thank you for the opportunity to testify toda today. Doctor robinson. Good morning thank you acting chairman and Ranking Member thank you for the opportunity to speak with you today from doctor robinson Vice President of over care non novacare and overseeing vaccines and industry four years ago with the state of affairs to talk about what we could do to remedy that mismatch influenza has returned each year bringing illness and death so to have a fourth strain of influenza and a new class of antivirals but yet we have still not solve the chief issue for effectiveness. Our domestic capacity has quadrupled since 2005 thanks to investments of Production Technologies and the ability to manufacture and make available that it is not fast enough to preempt the effects many candidates ive emerged over the past 40 years been an across the finish line. In slow vaccine production and with the universal vaccines and what those viral antigens with the strong protective response it with those subtypes so with that strong that is circulating with seasonal influenza and a primer for a pandemic the story of the influenza vaccine is long innovation has driven the vaccine the most expensive effort comprised into the matrix protein they in the two proteins that were developed and to be eugenic as well. And teethree mentioned earlier one of these discoveries and with the gluten vaccine to show and that leads to new developments and those candidates the other discovery with those antibodies and malaise protein that has been a target for antivirals for many years they widely diverse influenza virus to initiate another wave vaccine and has a next generation of flu vaccine. On the issue of more rapid production this synthetic Vaccine Technology could expedite technology production. Weeks and months could be saved in vaccine production this could allow the season to look at the strains when a mismatch occurs between the circulating virus and the vaccine. The production time for 600 million doses could be reduced from six months to three months and become available before the pandemic hits and that could be a faster way to distribute vaccines they are encapsulated the prisms to have the properties and the ability to administer vaccine transdermal for a selfadministered patch. These innovations and discoveries will make it into the 20 twenties without multi sustained funding through cdc with our Industry Partners with your continued wisdom and generosity and support, help us to finish the journey. Thank you. At this point we will begin our first round of questions the chair recognizes himself a five minutes. Doctor robinson thank you for your service in florida and having to meet with the another International Organization i had the chance to meet with an organization that looks at bringing the International Community together along with the private sector as well as vaccines for emerging diseases so if you could elaborate on the mission and the biggest point for me is the United States currently doesnt participate i would be curious about your opinion and if you want to elaborate on that. I smile when it is brought up my former deputy was Richard Hatchett who is the current ceo. Should us participate in the activities of Infectious Disease and development of vaccine . The answer is we already are. When the conception occurred in 2014 and it became a reality in 2017 nih specifically had investments of emerging Infectious Disease and vaccines like ebola and seek a virus and others and that would contain on continue the us governments efforts in these specific areas so we do support what they do in many cases we have contracts that support the same projects without duplication. To play off of that for a moment but with some of the threats if we look at emerging diseases and some of those pandemic threats what is the capacity within the private sector to ramp up and quickly identify a Central Vaccine to mitigate that pathogen just from your perspective quick. I will give it in the context of where i started like my Public Service in 2004 you would do once a year to respond. My first was the influenza virus of how we can actually make a vaccine toward that. Since that time we had a real live test in 2013 with the emergence of h 17 and that would normally take six months to introduce the vaccine we brought it down closer to the three months there is a specific reason why and as you heard we could get the sequence immediately actually was april fools day to move forward within weeks to be distributed not only to the vaccine manufacturers themselves but also by the summer we had those vaccines in Clinical Trials so in record time we could do that. So what were talking about today now we go further and the goal is to have the vaccine produced and available within 12 weeks. Medical recordd electronic records would allow you to do your job better when i think about medical delivery in the Health Care System today its amazing the advancements that have been made but i think Public Health has been left behind a little bit and we are still dealing with faxes and phone calls and spreadsheets and it does impact our ability to quickly respond to a situation so if immunization records were able to be quickly linked to our disease reporting system, if we were able to get electronic case report and see the data as it is coming in and digest that in the Health Department we would be able to respond much faster. Much of what we do and much of the pandemic suite of today we scratch our heads and we are struggling with the data sharing and management of so much big data. Public health needs to have our systems renewed and reinvested in. Cst has produced a book with conjunction of a lot of stakeholder stories that talk about why Public Health and the time is now to invest money in the data systems. Of the chair recognizes the Ranking Member for five minutes. In your testimony you highlight the Clinical Trials that showed the vaccines that are stockpiled remain highly effective even after ten years in storage. How do they work to improve the shelf life of stockpiled vaccines and other pandemic emergency is . Thank you for the question. We started in 2005 building a stockpile into these would be to treat the individuals that are highly foldable, highrisk and critical to make sure the country still operates under a severe pandemic. Around 27 million doses. And that was actually for all the different strains that have been shown to have potential for the viruses as described a moment ago to the new ways of the viruses. Through the process we meet twice a year and go over them to see which ones are available. But in 2015 there was a question that came up from the members. The vaccine that you have stockpiled in the companys come is it still good, and the answer was a we know that they look really good. But he said thats not enough so we did a Clinical Study using the newly made vaccine against that which had been made to tens before and the results of the which have been published to show that they were equal and still highly immunogenic and would be used to protect those individuals. Thank you, doctor. You suggested the use of Artificial Intelligence Machine Learning can be useful to identify outbreaks early and encourage individuals to get vaccinated. Can you elaborate further how this can be utilized . Sure. Thank you for the question. Public health does have a lot of data. Its not interconnected and i think the ability to look at birth and death certificates and immunization rates and existing combined with sensors track information and behavior information on poverty and immigration status, all of those other data sets help us understand better at the Community Level and what are the limitations to vaccination or access to health care or maybe language barriers. When we are able to use all the data that google has at their hands and we dont i think we will be the better able to target for the efforts should go. As an example during the opioid crisis, we and other states have been looking out to the ability assessments so we are looking at where are the deaths happening due to the overdose and babies being born with me to become neonatal syndrome and where does that overlaid with poverty and other statistics thats the use of big data to look at vulnerabilities and target where we should be looking. We could be doing that with many markings had we had the technology and interconnection. Doctor murphy. Thank you mr. Chairman and i appreciate your expertise. First question is for the her watkins. I was looking through some of the copies that you have with medical records and having experienced at the explosion of Electronic Medical records in the last 25 years i see the challenges are it. If you could wave a magic wand there is a way to pull data. Most of which dont talk to one another and unless we have a single system im not sure what this would look like a so im interested in your thoughts of the reality and purposes altogether are a great one but do devil is in the details. What does that look like . Thank you for that question. I would also refer you to this report that has been done and we can get you to a copy of that. What we are talking about is modernizing systems we already have. So the Laboratory System and its ability to rapidly transmit data between us and the provider and the cdc and handle those genetic results needs to be modernized and made more interoperable. Death and birth certificate registries need to be more rapid. We shouldnt be having paper records of these important documents. The immunization registry should be interconnected with our other disease reports. The electronic disease Collection System should be able to know if youve got an influenza and the death certificate comes i shouldnt have to wait for weeks. I should be able to see that within realtime. So looking at being able to bring those then, the men, theyg a lot of work on electronic case records and modernizing all the system. What we are talking about is bringing all states up to a better level. Some states are far behind and some are behind in some things but not in others and then i think about a pandemic or the next emerging issue, i need, we dont want Public Health to be the weak link in the chain. We found it to protect your family, my family and the Public Health with the same tools and at the same speed so thats what we are talking about. Thank you for the question. Its a daunting task. I will tell you if you cant entirely additional level of the data entry but then again thats what we do. We work on data. We would like to get out of the data entry. I have some analogies for you if i may. To me its like im sure we all have private positions, we have Healthcare Providers and they are not sharing information hand with him, they are not blocking your results in a spreadsheet. They are working in the modern world with modern technology and Public Health is the front line. Its like building a space probe and forgetting to put in the advanced communication data sharing aspect and i feel like in this modernization of health care and vaccine innovation we are thinking about all that we need to be thinking about the data sharing so that we can be the frontline of Public Health and not a weak link of the cha chain. I agree those are the issues it isnt cancer and other things you need to come activity. One other quick question. I wondered if you could speak we talked a little bit about the vaccines that come from eggs. Can you speak to why you dont believe that the technology is taking up or are we making Good Progress towards moving away from the vaccines . We made a timeshift and how we are going to move towards greater absorption when we dont have some of the problems with mismatches, first of all we have to realize the influenza vaccine industry is a commodity. I will say that if there is promise he debates the promise of that is actually licensed no where that arbetter internally w influenza vaccine candidate so we need to expedite that anticipated with the continued efforts that we have had with good forms. One followup. Do you think that the recalcitrance to doing that is predatory or the economies of the cost . Syndicate is not regulatory. The industry part of that now will say we dont want to do that because they have to go the entire process of getting a new vaccine and that is the normal course of Vaccine Development. The problem is why spend money we dont have to and that is the reality. Thank you very much. Thank you mr. Chair. Doctor robinson you may have touched on this in the first panel, but the whole public media social media conspiracy theories about vaccinations causing autism, how much of an effect does this have on people getting vaccinated and how much of an effect of people not getting vaccinated does this have on Public Health . The first part is how much, what was the effect of the antivaccine groups for autism. We fought this battle during the last decade and i will say that to a great extent that battle has been won and was shown there is no link between vaccination and autism. Let me ask a followup. You say that it has been one. We have a new wave of antivaccination and im very concerned about 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 years. And im very alarmed by that because again it isnt the real issue here. There are some for instance my friend Robert Kennedy junior is a major antibaxter and hes not for anarchy. I think that his issue was thinking as a preservative that was the cause is that correct . That is one of the platforms they have espoused. Have there been studies to show that is wrong . It is any more tight a typose some vaccines i will say that we made an effort in 2008 with influenza vaccine to remove that. As he said in testimony earlier, the cdc and fda are mounting efforts to be able to minimize that, but again the amounts are not the kind that mr. Kennedy has been talking about. Doctor watkins, do you have a perspective on this as well . I think publichealth is worried about the sentiment and that we need to do a better job of communicating the efficacy of the vaccine and the benefits that it does in addition to preventing disease and also the lessons and severity of complications and particularly for those most at risk so that prevents death and hospitalization. Public health thinks a lot about the fact where do people get their Health Information and how do they communicate with each other and we need to do a better job of producing, convincing messages that are shared on different platforms. How many people do you know where do you figure die annually from the flu . I dont have that number in my head but we can get it for you. At the lowend, 10,000 upwards to 48,000 a year. So more likely than not if they had the vaccine you dont know some of them might not have gotten it in that particular strain but more likely than not that would have been reduced greatly. Thats correct. Thank you. I am a big proponent of vaccinations. My father was a pediatrician, he gave vaccines. In 1954 he gave a vaccine to second grade students in the test trials. Have a brother in second grade, he gave him the vaccine. I was in kindergarten, he brought it home to give to me and he had second thoughts because it was outside this charge. Within two months i got polio. Vaccines are good. I wont yield back the balance of my time. We will open up two additional questions and i will start by recognizing myself. In the preparedness we have been having conversations with Companies Like google, and i know that they have been doing some work identifying particular search words that may pop up that would then allow us to rapidly say if people are searching the term fever etc. To try typically going to let say a country in africa or someplace else, are you familiar with any of those, have they been successful, not successful etc. . Public health is aware of those kind of crowd sourcing tools that look at gi symptoms or fever, but we havent been using them in Public Health. What we are interested in because we are a system that uses casebased surveillance we know your name if you are sick we are counting you as an individual, but we have extended a little where we are looking at the Emergency Departments gaining a lot of information that way. I cant say whether its been validated through publichealth methods. I can say looking at Emergency Departments are you seeing a spike in this come about or the other has been incredibly effective not just identifying the uptake of the flu but many other diseases including being able to identify clusters of illnesses. Do you want to add anything . I still think as we are looking at local health and Public Awareness we need to continue to work with these Technology Companies that part of that rapidl the rapidly respd getting ahead of the pandemics is quickly saying lets get someone out there and identify with the pathogen is and see if we cant mitigate it at the source is that correct . Absolutely. But with all due respect i think publichealth is under source and under resourced so our ability to do that is contingent on us being able to modernize. Do publicHealth Information speak to ecosystems speak across state lines . Not necessarily, no. That isnt because of any regulatory issues we have placed as congress. Its just under resourced and order ohio doesnt have the jurisdiction to see that john smith in pennsylvania has influenza. Its my jurisdiction. But we could do a better job of sharing not identify data and when there is an outbreak and we need to share that information, we do so securely. But no, for example in my state philadelphia is on a different system in the state and it does matter. We have to work hard to share data and when they want to see statewide data, we have to work with philadelphia to harmonize it. Its inefficient. Let me ask another question about vaccination rates and i guess what he did it this way. When i was a child i got a lot of my vaccines out of school. I am an internist by training but its always occurred to me that if for efficiencys sake for the multidose vaccines youve got to captivate the audience of. Kids are going there and the overhead if you rulebased nurses were publichealth nurse is able to go there it would be more effective and efficient. We do use that venue. I think schoolbased nurses are a resource that is shrinking and so not all schools have access to that. I do think that we have done it broader and have shrunk that footprint. This probably concerns about liability but from the efficacy perspective, i think these investments in the nurses and overhead etc. And again the efficiency particularly difficult it is vaccines because you lose a lot of kids, they dont come in a month later for the vaccine and again i believe you could rapidly boost the number of children that are getting vaccinated if we were to utilize tools like that and to ask one last question with regards to measles etc. , i would be curious from your perspective as a Public Health professional help pennsylvania and others around the country are addressing these periodic outbreaks. Sure. I mean, we are exhausted i will be honest. I was just at a conference in new york and i cant imagine what they have had to go through to people to address those hundreds of thousands of cases. In pennsylvania, i think we are up at 17 cases. What i thinbut i think you done this for every case, im birds have people are likely exposed and if its in close contact exposure, if he were infectious with measles right now, everyone in this room and everyone further two hours after you have left would have been exposed. Publichealth notifies you. We track you down and assess your immunity. We work to make sure not only are you taking care of everyone youve exposed is notified and properly treated them either you arcome either youare immune or f not a candidate prophylaxis in time you may be quarantined. Theres a lot of steps that going to measles and it is an enormous restraint. Its been difficult for new york or any of us that have had cases of measles. Thank you for your work and all of the publichealth professionals to doctor murphy if you have any additional questions. Thank you for coming. Let me ask a question just because we are looking at this at one of the levels increase with interconnectivity into challenges. My question is what have you done in the state of pennsylvania to talk to the other counties because Publichealth Departments at least in North Carolina are run by counties. What have you done on the state level to develop interconnectivity come and just on a corollary i did a lot of work in the legislature wit lege Opioid Epidemic and we have people on the board in North Carolina going into virginia getting prescriptions vice versa. So we worked closely with our state neighbors to develop a system somebody in virginia could no somebody is jumping across the line getting prescriptions. Its the same thing. Its a state interconnectivity. We look at the nation as a whole of the pandemics going on and these tend to be localized so what have you done an at the ste level to address the problem . We are structured differently than North Carolina and we have ten county and municipal jurisdictions. They are on the same system of disease surveillance and so we are able to share that. What happens is the lab reports come in to the state Health Office and we push it to the jurisdiction or to the district office. If you are in pittsburgh for example, we do collect it all in the same data system. Philadelphia is large and they are able to have their own in a different system. We work with them both from a deceased perspective and shared outbreak information alltime. We work with them from an it perspective to try to harmonize what we do. And of course we are always working with our neighbors appeared as hepatitis outbreaks, measles, patients dont have borders. You could be hospitalized in new jersey and go into going to a m care facility in pennsylvania. It happens all the time. We keep such that we could do it better, faster and without the misinformation if we were better electronically suited. Let me just follow up and. Are you not electronically suited in the different counties and why would you not appeal to your state rep within the federal government to make that happen . So, what i am talking about is the sharing of Laboratory Information with disneys surveillance and that disease surveillance we havent really invested money in this in a long time. Our immunization record is not connected to our disease surveillance record and im speaking from a national perspective. You asked me a pennsylvania question but i could be answering for many states. I dont know if youre immunization record in North Carolina is connected to your disease registry. For many states, it is not. Those are the kind of things that would help us get the data response faster. In the measles exposure situation, who has been immunized . That is a hard question. It shouldnt be, but it is a hard question. We have resorted to actually going to high schools whose records have looked them up for us because the physician had gone out of practice. Publichealth is a make it work kind of system and we just do what we need to do but we are getting further and further behind. One other quick question. In the success that we have seen against the hpv virus here i am trying to put myself out of business, where are we and where do you see us as far as other militancy vaccine, Prostate Cancer for example. I dont see the door being knocked down. Can you speak to that briefly . 20 years ago when i was in the in the street we actually worked on a Prostate Cancer vaccine and melanoma vaccine. What has driven the oncology vaccine has been supplanted by the antibodies that have been developed with Great Success the last 15 years so that is a moving the companies to a lesser degree. Some of the vaccines were extremely promising as we were evaluating them at the clinic and i would suspect once we reached this for these purposes we will see a resurgence of vaccine for different types of reappear probably in the next decade. Before we bring the hearing for a close, i want to thank both of the witnesses were testifying before the committee today. The record will remain open for any additional questions. The committee may ask the witnesses. They are excused into the hearing is now adjourned. [inaudible conversations] [inaudible conversations] to mat 181171 Comcast Corporation versus National Association of africanamerican owned media
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