Virus itself. Lack of knowledge and misinformation has stoked apprehension and fear among many. According to the World Health Organization some of the reasons why we dont know more about this disease include a relatively small proportion of about one in four, some say one in five of people develop symptoms, a virus only detectable for a few days and infected peoples blood. The failure of current tests to definitively distinguish zika from similar viruses such as dengue. Especially pregnant women wear protective clothing and stay indoors if possible with Windows Doors or screened. Or diligently protect against mosquito bites if travel is unavoidable. Currently no therapeutics exist to treat zika virus nor is there a vaccine. But that gap need not be forever. One of our distinguished Witnesses Today, doctor Anthony Fauci will explain the scope of nih research on the zika virus as well as Vector Control. Surely Lessons Learned from years of malaria Vector Control have ek witability to zika virus. Dr. Thomas frieden who has been here so many times during the ebola problem, and Ariel Menendez, who in like manner has been here and has done a wonderful job on all of these issues. The u. S. Government has for quite some time promoted such tactics as insecticide laced mosquito nets, window endorsed screen small pool and container drainage and use of strong but safe pesticides to eradicate mosquitos. However our programs are largely tailored for developing countries with the reemergence of dengue in the Southern United States and hawaii, we have to step up our domestic efforts to control mosquitos before warmer weather leads to an explosion of mosquito population during an epidemic in the homeland. According to dr. Luiz alberto machado, ambassador of brazil to the United States, the brazilian government has deployed 220,000 troops and 300,000 Health Agents to fight the vector of the infection by visiting communities to educate the population and help eliminate all mosquito breeding grounds. Experts cite possible links with the zia infection of pregnant mothers and the dangers of their unborn children. No definitive proof of such a linkage according to brazils ambassador and i quote him in part, microcephaly in newborn babies can also be caused by a number of other diseases. Health experts are dealing with something new. The link is unprecedented, he says, in scientific literature and requires in depth studies and analyses. As a matter of fact an a. P. Story just out, the president of colombia said in all the cases theres not one of microcephaly. A supplemental some of 1. 8 billion in order to combat zika virus there, quote, may be a link. Dr. Marcos, director of the communicable said theres a Broad Spectrum of impacts from mild to severe. A fact sheet on microcephaly in Boston Children hospitals notes some children with microcephaly have normal intelligence and experience no particular difficulty with school work. However, many children with the disease especially those with severe cases face mild to significant learning disabilities, impaired motor functions, difficulty with movement and balance and speech delays. In the meantime we must work harder to prevent maternal infections and devise compassionate ways to any child born from this or any other infection is welcomed, love and gets the care that he or she needs. Usaids Ariel Menendez will say we need to support best practices. Children with disabilitiessuppo well. And a brazilian journalist born with microcephaly told the bbc in a february 5th interview that the conditions, and i quote her in part, is a box of surprises. You may suffer from Serious Problems or you may not. On the day i was born, she says, the doctor said i had no chance of survival. She will not walk, she will not talk. But he like many others the doctor that is, was wrong. I grew up, went to school, went to university. Today im a journalist and i write a blog. People need to put their prejudices aside and learn about this syndrome, closed quote. This hearing will look at the implications of the current and longterm threat from the zika virus. And we have assembled expert Infectious Health leaders from the centers for Disease Control and prevention, the National Institutes of health and u. S. Agency for International Development to help us to understand where we are and where do we go from here. I would just note paraphernalia thetically that for more than four years ive been urging passage of my bill and dr. Menendez or Pablo Menendez has been very supportive and has testified at several hearings on this issue of neglected tropical diseases. The full Foreign AffairsCommittee Approved the bill last month. Since 2011 our committee has discussed efforts on more study and identify tropical diseases and find diagnostics, vaccines and treatments of such illnesses. At that time 2011 west nile virus was quickly making its way across the globe including in the United States from origins in east africa. Ebola first discovered in remote area of africa in 1976 caused a Global Health crisis only two years ago. And finally, and i say this with some concern, for the second Consecutive Year the administration has slashed funding for Global Health accounts in the Budget Proposal released this week including a 19 cut for Global Programs on tuberculosis, the worlds leading Infectious Disease killer. I know that the three distinguished Witnesses Today that is not your prerogative, but that is what was sent up to the capitol hill. Additionally the administration is being short sided in regards with tropical diseases cutting that program by nearly 15 . In the face of the wave of Infectious Diseases in recent years including multidrug resistant tuberculosis, west nile virus, ebola and now zika the administrations disregard for this danger iss in eexplica. Zika created global alarm, before the next explosive Health Crisis appears we must provide sufficient resources to the study of tropical diseases. I would note hr1797 authorizes the creation of centers of excellence to study every aspect of these diseases. And i would note in the year 2000 and even most recently just a few years ago legislation i authored on autism created such centers of excellence at nih and cdc and i think that has had a huge impact in combatting that developmental disability. So hopefully well get some traction on that legislation. Id like to now yield to the distinguished chairman my good friend mr. Duncan. Well, i thank the chairman, chairman smith, for the joint hearing here. And appreciate us being involved. The western hemisphere subcommittee is wanting to get engaged in this issue because were seeing this virus here. And theres a lot of concern with the allies and neighbors in the region before 30 days ago a lot of folks in my district never heard the word zika virus. So the zika virus virtually unknown until the first reported case was on Easter Island in february 2014. Its now exploded in the region with cases of 26 countries, territories and the World Health Organization projecting zika will likely spread almost to every single country in the americas. While symptoms for the majority of people who contract zika are quite mild, the disturbing potential links of zika causing microcephaly in unborn babies and gbs syndrome has created panic around the region. Last month brazil having reported over 4,000 suspected cases of microcephaly potentially linked to zika as of october 2015. Although further investigation is confirmed microcephaly in just 400 of the suspected 4,000 cases and only 17 in which tested positive for sdzika, concerns remain very real for those living in the conditions. Also reported an increase in gbs cases potentially connected to zika. Just last week colombia confirmed the first three deaths of patients infected with zika. In may of 2015 pan american Health Organization issued an alert regarding the first confirmed zika case in brazil. Last month u. S. Centers for Disease Control issued a level two alert warning to follow enhanced precautions for pregnant women and women of childbearing age and any travel to zika infected places. Subsequently last week the w. H. O. Declared the spread of zika an International Public health emergency. President obama has since responded. The request this week for congress to provide an additional 1. 8 billion to address the zika crisis. Im deeply concerned about the impact zika virus can have where most of the population has little or no immunity where mosquitos are simply a part of everyday life especially in poor communities. Many Governments Health care systems are not equipped to handle a mass influx of microcephaly or gbs cases. In particular venezuela is reporting of having over 4700 zika cases with a lack of even basic Health Care Options available due to horrible economic mismanagement, venezuelas ability to address rising numbers of zika cases and provide the needed care for women in particular is severely in doubt and deeply worrisome. With some predicting that venezuela could see the regions worst zika cases. In contrast, brazil, the host of this years summer olympics in august, has made huge efforts to curb the spread of zika but fighting with genetically modified mosquitos, deploying hundreds of thousands of troops to help educate the population about and to help research the virus and develop treatments. Given the rapid spread of the zika virus and americas, several countries have tried to buy time to address the problems by urging women to postpone pregnancy. Colombia, jamaica, ecuador and el salvador all issued these re recommendations. However they may try to delay, many women unfortunately do not have the luxury of simply choosing to wait. Crime and violence plague much of the region, corruption and impunity are endemic and women are often caught in the cross hairs consequently facing unexpected pregnancies. As a result the zika virus has created a growing push for latin american countries to liberalize their laws to allow greater access to contraception and abortion. On february 5th the u. N. High commissioner for human rights called on latin american countries affected by the zika virus to increase this access. Today, latin american countries have some of the strongest laws on the books protecting life of the unborn. Chi chile, Dominican Republic and el salvador ban abortion completely, uruguay and cuba legalized abortion, other countries only allow abortion in the case of rape, incest or the threat of the life of the mother. This pushed for more Abortion Access due to the potential birth defects from microcephaly is heartbreaking especially since there are different degrees and some children born with the special needs may go onto live very normal lives. I think you gave a prime example flt regardless i believe every person including the unborn child is made an image of god and therefore has inherent worth. Thus we must do everything we can to support the very real needs of women in latin america and the caribbean who are facing incredibly difficult situations while also seeking to protect the lives of the unborn children. So in conclusion its my hope Witnesses Today will provide testimony of how the u. S. And countries around the world, especially here in the western hemisphere can fight protect against the spread of zika while simultaneously working together to provide health care that addresses the needs of women, promotes life of the unborn and promotes therapy options for those born with microcephaly and gbs. I yield back. Thank you very much. I would like to yield to dr. Burr. Thank you, gentlemen. Thank you for the timely hearing here. Obviously this is an esteemed panel. As a physician who has Public Health work in nicaragua, in areas that were finding endemic of certainly dengue fever when i was down there but now with zika virus, this is going to be a challenge. Certainly the mosquito were dealing with is not an easy one to eradicate, not an easy one to prevent. But the purpose of this hearing is to make sure we get information out and also dispel misinformation. And in epidemics like this that is incredibly important. Because lack of knowledge because the spread of misinformation certainly can create panic. And what we want to do is reassure the public that we are taking this outbreak and this epidemic very seriously. But were doing things in a responsible way. I look forward to the testimony of our witnesses on, you know, how were approaching this, the steps that we need to take. I applaud the president for his request of 1. 8 billion, how we best can utilize those funds. But theres a lot that we dont know. I mean, weve got to come up with more rapid diagnostic tests. Weve certainly got to, you know, understand the extent of folks that are infected but also the fact that the vast majority of folks that do get infected probably are asymptommatic. We also know theres heightened risk in women of childbearing age and certainly women who are currently pregnant. You know, certainly want to hear the testimony of the witnesses with regards to what we can be doing. But as a physician myself certainly one thing we can do in endemic areas is liberalizing access to contraception, making sure that more women of childbearing age in endemic regions have access to full contraception. This isnt about abortion or not abortion, this is about, you know, making sure that those women who are not planning on getting pregnant have the ability to prevent that pregnancy until we get a better understanding of what were dealing with. And i would make a strong push in endemic countries to dedicate some of those resources to access to those Family Planning services, to access to contraception, to access to birth control. Again, incredibly important. For u. S. Citizens that are planning on travel, you know, obviously if youre of childbearing age, you know, we would urge you to take the caution. If youre pregnant, again, i would hear what those travel restrictions are, but my sense is we would urge those women who are currently pregnant not to travel to endemic areas. In addition id be curious, you know, it is my sense that, you know, given the interconnectedness of the globe, weve started to see some zika virus cases pop up in the United States. My sense is these are generally folks that have traveled to endemic area who is are now returning. Id also be curious about the p epidemiology in terms of where were seeing the virus. We may be potentially seeing it in see men and saliva and other bodily fluids. What we can do in terms of recommendations there. Again, you know, i applaud the panel here. You know, again, looking at this as a health care professional, i would urge that we dont panic. I would urge that we collect the data, the information. You know, if folks are traveling to endemic areas, obviously take the usual precautions to prevent mosquito bites. If youre of childbearing age, you know, certainly take those precautions. I would urge that we do use some of the resources that the president has requested to make access to full contraception more available for women of childbearing age in these endemic regions. That is one simple thing we can do to prevent, you know, congenital abnormalities and so forth. Again, i dont think anyone argues that that isnt good medicine or and good prevention. I look forward to the testimony of the witnesses and again, thank you. I would like to now yield to the Ranking Member of the western hemisphere committee, my good friend and colleague from new jersey. Thank you, chairman. And thank you for holding these hearings. I know how much you care about world health and people, and this certainly is a theme a situation that we have to deal with right now. You know, the lack of clarity on the virus and its effects and its treatment make it all more important that we respond to this more aggressively than we have in some of the other diseases. Very concerned now that we have the olympics, a lot of people going into brazil. And i think the brazilian people should be the brazilian government should be very concerned that a crisis doesnt spur because i dont think anybody would go to the olympics if you have the situation where it gets to be panicky. So i want to hear what the panel has to say. And i want to thank the chairman, again, and Ranking Member for holding this hearing. Thank you. I would like to acknowledge professor of entimology. Shes an expert on the mosquitos that carry zika and provided us some testimony without objection will be made part of the record. Introducing our very distinguished panel beginning first with dr. Tom frieden whos been director of the centers of Disease Control and prevention since june of 2009 and has dedicated his career to fighting infectious and chronic diseases both here and the United States abroad. He led new york citys program that controlled tuberculosis and reduced multidrug cases by more than 80 and worked in india for five years helping build a Tuberculosis Control Program that saved nearly 3 million lives. As the commissioner of new yorks health department, led illness and death increased Life Expectancy substantially. Hes a recipient of numerous awards and honors and has published more than 200 scientific articles. Well then go to dr. Anthony fauci who is director of the National Institute and allergy and Infectious Diseases at the institute of health. Dr. Fauci has overseen an Extensive Research portfolio devoted to preventing and treating Infectious Diseases made numerous important discoveries regarding hiv aids. Dr. Fauci serves as one of the key advisers to the white house on global aids issues and on initiatives to bolster medical and Public Health preparedness against emerging Infectious Disease threats such as ebola and pandemic influenza. Hes also one of the principle architects of the president s emergency plan for aids relief. Now well hear from dr. Ariel Pablo Menendez who is the assistant administrator for Global Health at usaid, a position he assumed in august of 2011. Dr. Pablo menendez joined the Leadership Team with a vision to shape the bureau for Global Healths efforts to accomplish a measurable and Sustainable Impact on the lives of people in developing countries. Before joining usaid he worked on Global Health strategy and transformation of Health Systems in africa as well as asia. He also served as director of Knowledge Management at the World Health Organization. Dr. Pablo menendez is a Board Certified internist and was a professor of clinical medicine and epidemiology. The floor is yours. Thank you very much for calling this hearing and thank you Ranking Member for the opportunity to discuss zika with you. We look forward to a full and open discussion. And i want to start at the outset with some basic facts. First, we are quite literally discovering more about zika every single day. Were working around the clock to find out as much as we can as quickly as we can to inform the public and to do everything that we can do to reduce the risk to pregnant women. Zika is new, and new diseases can be scary particularly when they may affect the most vulnerable among us. Right now the most important thing for americans to know is this, if youre pregnant, we recommend you not go to a place where zika is spreading. And if youre pregnant and you live in an area where zika is spreading, do everything you can to protect yourself against mosquito bites. The 80s mosquito that spreads this particular virus is very difficult to control. And ill talk about that more in a bit, but its a very important point when we think about what we can do to respond to zika in the shortterm and in the longer term. Cdc is working 24 7 to get more information. We elevated our level of response on monday of this week to level one after our activation of our Emergency Operations center last month. We are committed to continuing to share information as quickly as possible with the public and with Health Care Providers and policymakers so that people can make the best possible decisions about health based on the most recent and accurate data. We will also continue to provide and update our guidance as soon as we know and learn more. This is the latest in a series of unpredicted and in many cases unpredictable Health Threats. And it emphasizes how crucially important it is that we continue to strengthen the systems that will find, stop and prevent Health Threats wherever they emerge around the world, both to help other countries and to protect americans here at home. I want to start with what we know. As you said, mr. Chairman, the virus was first identified in 1947. It was first identified to cause an outbreak in an outbreak that the cdc scientists investigated it is believed to cause no symptoms in approximately 80 of the people infected. And mild symptoms in virtually all of the rest. The mosquito that spreads it, species, ill show a picture of our enemy here, if i can advance this. Oops. All right. Theres the enemy. The aedes aegypti mosquito is a very challenging what we call disease vector to control. Its an indoor biter. It bites all through the day including at dawn and dusk. It hides in closets and under tables and places that are hard to get to. Its larvae or eggs can be drought resistant and persist for some time. And it can bite four or five people in the course of one blood meal, meaning it can spread disease quite quickly. Our efforts to control it are challenging. Its hard to eliminate. I want to show a bit about what has happened in recent years with dengue and two viruses spread by the very same mosquito as zika is. In red on this map you see the approximate geographic distribution of dengue around the world. And you see that its widely distributed in that equatorial band essentially above and below throughout the world. Dengue has been increasingly present in recent years. Now if you look at chikungunya. Its a word means bent over in pain. Can cause a severe painful disease. And dengue can be very severe and fatal. For more than 60 years chikungunya was present in other parts of the world but not in our hemisphere. But over the past few years its spread widely within our hemisphere. And these are the current known places where both dengue and chikungunya have been documented to spread. Anywhere either of these diseases is present, zika may well follow in the coming weeks, months and years. Now, on microcephaly, this is an extraordinarily unusual event. And i want to emphasize that. In 1941 scientists recognized that rubella causes the rubella syndrome. And with the vaccine weve virtually eliminated that in the u. S. In 1962 scientists identified another virus as a cause of severe fetal malformations. And in the past fifty years were not aware of any other viral cause of a significant number of birth defects. In fact, were not aware of any prior mosquito borne cause of fee toll malformations, if in fact this is confirmed. Syndrome youve heard about a weakness after infections is a different of many proses seize can occur in one in 1,000 or one in 100,000 people whove had an infection andin crea in kreecres like its related as a postinfection. It can be severe. But the big difference here is the microcephaly. Next id like to talk about what based on what we know today is likely to happen over the coming weeks and months. And what were doing about it to protect americans. First, we will discover more each and every day. And ill show you later today some new data that was just released within the past hour. Well learn about maternal to child transmission, about any possible cofactors such as other infections or nutritional factors that may increase or decrease a womans likelihood of having the zika infection transmitted to her fetus. Well learn more about the relationship with both microcephaly and gbs from studies were doing today with partners in brazil, colombia, puerto rico and other places. Well develop better diagnostics. Currently we can diagnose the active zika infection. If someone is sick with zika, we can find it in their blood. But if its a couple of weeks or couple of months later, figuring out if theyve had zika is very complex. And cdc scientists have worked for years to develop a test for that, we have a test but it is one that can have false positives of prior infection. Well learn more about the level of risk, whether symptomati symptomatic zika is more likely to cause than asymptomatic. Well learn about how long a man infected with zika may continue to harbor zika in semen. Well learn more how to stop the vector, the mosquito that spreads zika virus. For all of these things we will need Additional Resources, which is why the emergency supplemental request is so important. So one thing that will happen is well learn more. A second thing that will happen is we will see more cases among travelers to the u. S. Some of them will be pregnant. Thats why weve issued travel advice, not travel if youre pregnant. And weve worked with doctors and clinicians and others to provide that advice. Third, we will likely see significant numbers of cases in puerto rico and other u. S. Territories where there may be intensive spread of zika. This is a particularly urgent area. And id like to show you a series of slides that show what happened in the chikungunya outbreak a little under two years ago. In may of 2014, may 5th of 2014, the first chikungunya case was identified in puerto rico. By two weeks later it had begun to spread. And each of these slides is a twoweek period. Two weeks later, two weeks later, two weeks later, two weeks later. And by october it was in almost all of puerto rico. And has now affected at least a quarter of the Adult Population of puerto rico. So this can spread very rapidly in a population. We will move rapidly to reduce the risk pregnant women will become infected, monitor and reduce mosquito populations to the greatest extent possible. And the next thing that we may see happen is cases or clusters in part of the u. S. That have had dengue clusters in the past. Thats why we need support for local mosquito surveillance and control measures. We may also see sporadic cases elsewhere in the u. S. And of course unfortunately continued spread around the world. To finish what were doing now is in a whole of government way but with hhs as the lead, looking at what can be done to reduce the risk to pregnant women. And the cdc part of the supplemental request is 828 million to scale up prevention both for pregnant women, for reducing the risk of mosquitos, to prevent transfusion, organ transplant or other what we believe are rare potential forms of transmission. And in the future with nih in the lead, vaccination. To detect through Laboratory Tests cdc laboratories have developed the diagnostics that are being used in this country. And we are working around the clock to get these diagnostics out so that more people who want to be tested can be tested. Well improve clinical diagnosis and reporting, mosquito surveillance including the resistance of mosquitos to insecticides, which is very important to know so we can target our actions. And to understand to understand microcephaly more. Within the past hour cdc has released information from brazil on the findings of among four infants, two miscarriages at age 10 and 11 weeks, spontaneous miscarriages, and two infants who tragically had micro scepha and died within the first 24 hours of life. Working with our brazilian colleagues the cdc laboratory was able to identify the genetic material of the zika virus in the brain tissue of the infants who died from microcephaly. Well still need to understand the clinical and epidemiological patterns to make that link definitive. To do these visions and investi response we will need Additional Resources. It is complex and expensive. There are a series of measures we can take particularly in the u. S. Area of puerto rico and other parts that have had dengue transmission and we look forward to working with you to inform people about the latest information on zika and what we can do to stop it. Doctor, thank you very much for your testimony. Thank you very much, mr. Chairman. Chairman duncan. It is a pleasure to be with you this afternoon and to discuss with you the Research Conducted and supported by the National Institutes of health in addressing the zika virus situation that we currently find ourselves in. It is important to point out that we are part of a government wide and hhs concentrated effort with our Sister Agency cdc, fda and others within hhs, who address the Public Health issue of zika and our role is in the area of basic and clinical biomedical research. As shown on this slide, the National Institute of allergy and Infectious Diseases, the institute that i direct, has a dual mandate and the mandate is to not only in the classic way support a robust, basic and clinical Research Portfolio in microbiology and Infectious Diseases, but simultaneously to be able to respond almost immediately to a new and emerging threat. The situation we find ourselves in right now with zika. As i wrote in this article just a few weeks ago in the new england journal of medicine, d zika virus in the americas, yet another arborvirus threat. The point i made in this article, if you look just in the americas notwithstanding the rest of the world in the past few d decades weve seen viruses never before seen in the western hemisphere. West nile. Chick vic gun chikungunya in the caribbean. And now zika virus. They spread very rapidly. Ill explain a bit and leave time for questions later. The approach of the nih and nid has been the basic mandate to provide the basic understanding of december, the clinical research, resources for researchers throughout the country and the world, as well as Biotech Companies with the ultimate goal in developing what we call our countermeasures in the form of diagnostics, therapeutics, and vaccines. Lets take a very quick look at some of these and how they relate to the situation with zika. Dr. Frieden mentioned the issue of epidemiology and natural history. We have our grantees and contractors who have been studying similar diseases like dengue to try and understand what we call the natural history. What is the difference between symptomatic and asymptomatic disease. As what is the relationship, direct or indirect, alone or synergistic, between an infected pregnant woman and the development of congenital abnormalities like microcephaly. What indeed is the Broad Spectrum of the pathogenesis of microcephaly. All of these are questions were asking alone and together with our colleagues at the cdc to try and get quick answers to them. If one looks at the basic science, if you look at other viruses that we have been studying, hiv, influenza, or even ebola, because of the effort in trying to understand the fundamental molecular viralogy, we need to do the same thing with zika, study the viral structure. Study the brought outbreak in an island, and in french polynesia. If its evolved, has it impacted the pathogenesis and men fe manifestations of disease. Well screen for drugs and test for vaccines, so animal models are critical. Dr. Frieden mentioned the issue of Vector Control. The classic way to control that, but there are also some novel ways which were exploring but should not take the place of the classic ways, and that is things like the genetic manipulation of mosquitos or infection with other bacteria. Again to emphasize, this is not an easy thing to do, as dr. Frieden has emphasized. Vector control is a very important tool, but it is not easy to implement. We mentioned diagnostics. The cdc is taking the lead on that, but our grantees and contractors are using some of the knowledge gained from our study in chick gun kungunychiku and other to get more precise start of the art point of contact specific dying nis so we can tell a woman who may not another whether she was infected with zika during her pregnancy or before. Importantly our development in the role of a vaccine is actually encouraging news. The reason i say encouraging, is because weve had positive experience with the development of vaccine for over viruses. Case in point, dengue in which there is already an approved vaccine in brazil and mexico and we started last month a phase three trial of dengue in brazil, in collaboration with the institute of butantan. Even though we went through with phase one with good safety, we could not find a Pharmaceutical Company that wanted to partner with us because it was felt that this was not something that would have a good profit because of the target population. I dont believe at all that we will be left with this problem with zika since we already have a considerable amount of interest on the part of pharmaceutical companies. Were going to use the same technologies that we use to develop the vaccines for other viruses and were already manufacturing the what we call the construct for that which will make to the point of gnp detox and get to a phase one trial i would think and almost be certain by middle of this summer which would be asking for safety and immunogenicity. This is whats called the dna construct in which you insert the gene first of west nile well just substitute is and stick the gene of zika in, inject it into an individual which would produce now vie valuelike particles which we know are safe and we know theyre immunogenic. And therapeutics, since it is no. High on the priority and we have to do a lot of screening, we nonetheless are looking very carefully with our Drug Screening capability at possible that you are put therapeutics for it the entire class of those viruses. I want to close with this last slide which reminds us of something that i said at the very beginning of my presentation, that microbes have emerged, are emerging, and will continue to emerge. And i refer to it as the p perpetual challenge. We know were talkinging about zika today but next month or next year well be talking about Something Else in the same way last year we spoke about ebola. Hopefully and i know i want to thank the congress for the support that youve given us over the years to allow us to address these problems. Thank you very much, mr. Chairman. Be happy to answer any questions. Dr. Fauci, thank you very much for your testimony. All of your full statements which are very lengthy and detailed will be made a part of the record. Id like to go to dr. Mendez. Thank you, chairman duncan, Ranking Members and all the distinguished members of the committee for inviting me here to testify on the United States agency for International Development, usaids response to the serious concerns raised by this spreading in the americas of the zika virus. I want to recognize the leadership of my colleagues, dr. Frieden and dr. Fauci, that have been rapidly mobilized in the response and immediate investigation that we already are learning a lot. But as we have learned from other outbreaks, we cannot wait to figure all out before we begin to have this discussion and response. On monday the president submitted a fiscal year 2016 splu supplemental request to respond to the zika Virus Outbreak. This includes money for programs to be implemented by usaid to help countries affected by zika protect and respond to citizens and pro expect the spread to our homeland. Let me describe the proponents of the work we propose by usaid. First we will support Risk Communications and behavior change programs. Getting the rye information to the people, empowering people with the right information. This is going to be a rapidly evolving field. We dont want panic to take place in the region as we actively take actions to help people protect themselves from the zika as well as other mosquitoborne diseases. This include providing clean information for women concerning the risk of the zika virus and pregnancy and how to protect themselves. Community level messaging will be combined with mass media and social media campaigns. We will also partner with the private sector and are in discussions with companies in brazil at this moment to help us do that. Second, usaid will support implementation of a package of integrated Vector ManagementVector Control activities in communities at risk of zika. This will help reduce exposure to mosquitos and will take protect against other vectorborne diseases such as dengue as we heard just now. Specific activities will include Community Mobilization campaigns to eliminate standing water sources where mosquitos breed. Vector mapping to eliminate major breed pentaging sites and screening to protect home and workplaces. Pressures we have today are not optimal but they have been shown to work in a number of settings and we will certainly work with our partners in developing new tools. As we do we want to make sure they been available rapidly in the region. These efforts will build upon the foundation of experience of the successful Malaria Initiative aware that the zika virus is carried by a different mosquito, we have expertise in mapping, expertise in entomology that can be brought to bear in response to zika. Thirdly, usaid will help ensure women in affected countries will have access to Proper Health care and support. This will include training of Health Care Workers to provide advice, provide support for pregnant women including them access repellant to protect against mosquitoes and access to Family Planning as we hear from mr. Dunegcaduncan. This will be important to have information and serviced and methods as well as the care of the affected newborns. I know that the chairmans always had a concern for the newborn. Finally, innovation. We can take steps to spur innovation of new tools and development to enhance our responsibility and protect future outbreaks. The research nih leads is significant. Our partners at cdc are supporting this Critical Research already and we need to better understand the virus and the relationship with birth defects and developing new tools. As we have learned, the markets need to be incentivized, need to be organized. And markets can be significantly important to help us bring those tools to fruition and to quickly deploy them in the region. Market incentives can be used throughout the Development Process from cat liesing Early Stage Development of die diagnostics and vaccine and Product Manufacturing and scale. Usaid used grant challenges to rapidly source new innovations to address key gaps in our response. We are planning also considering new grant challenges to bring new ideas to bring the private sector and diagnostics back to control. Mr. Chairman, zika, sars, influenza and ebola all point to a landscape interaction between humans, animals, vek dors is constantly changing. For our civilization in the first time we are seeing a explosion in the tropical regions of the world and increasie ining need demand. Urbanization changes in Global Travel and the like. Ecological transformation and climate weather pattern change are increasingly interconnected in our world. That means mosquito borne skis such as zika can appear in areas they hadnt before. This rapidly changing dynamics means we have to be prepared for what is seemingly unpredictable. A recent report from the National Academy of medicine estimates the annualized cost of pandemic risk is 60 billion a year. Other estimates are actually higher than that. So we need to make sure that we are prepared because both the cost of life and the cost in the economy is likely to grow in coming days. As we address the immediate needs of the zikaaffected population, we must underscore the need to improve National Systems to prevent and dictate response to these pathogens. Beyond dealing with individual outbreaks as dr. Fauci put as a perpetual challenge, we also need to Pay Attention to the landscape, better understand the territory where the usaid has supported work. To help predict and mitigate the impact on highconsequent pathogens. Each year we take hundreds of pathogens and screen and make sure they dont jump into the human space. We find them in primates, in birds, in bats, in rodents. But there is a logic to it and we want to make sure science is brought to bear to prepare and predict these challenges. We must keep this Bigger Picture and the longterm view if we are to prevail against this rapidly evolving what i call the microbiome of the world. In conclusion, mr. Chairman, usaid is strongly committed to combating the zika Virus Outbreak of today and in strengthen be the capacity to make sure future threats, rapidly and effectively controlled at their source and before they pose a threat to the global community. We look to your partnership and your leadership as we continue this fight. I appreciate the opportunity to share the contributions we are making in this battle. Thank you very much. Doctor, thank you very much. The committees will be following the fiveminute rule for member questioning. Id like to begin, ill throw out some questions, then yield to my colleagues and good friends. First on Vector Control capacity, in africa it took years to build up that capability. Especially with the malaria efforts. I know than safe and effective is important so we dont have obviously unintended consequences from unsafe pesticides, for example. I know personally we use my wife and i a compound at home for certain bugs and insects. But the question would arise what are you suggesting that they use . Is there an adequate supply in these countries and an adequate delivery mode . Secondly on brazil, this seems that the areas of the highest prevalence is in extreme poverty. I know because we work on stunting and other issues in this subcommittee all the time. The first thousand days of life in my opinion is one of the most transformative efforts where nutrition, micronutrients and other kinds of assistance, prenatal efforts, increases the immunity on the part of the baby. It also makes the mom healthier. So from conception to the second birthday, those first thousand days are absolutely transformative. Are you looking into vulnerabilities based on weak or compromised immune system. Children where there is extreme poverty and lack of nutrition are likely to have that problem. Third, after the childs transmission are you welcoming to develop a way like you, the pharmaceuticals and others did so effectively with regards to mother to child transmission with hiv aids . And finally in the United States, landmark civil rights legislation, the americans with disabilities act ensures that persons with disabilities are fully enfranchised into society. Looking to encourage other countries to adopt best practices for supporting children with microcephaly. You might want to explain how what that will look like in terms of helping those countries care for children with disabilities. Maybe i can start with your first couple of questions. On Vector Control, our approach is to reduce mosquito populations by integrated comprehensive approach. That means reducing standing water, using larvacides. There are various forms of larvacides. Weve looked at outdoor spraying. Many. Countries use outdoor spraying because the vector bites indoors and because of some other characteristics, there may be limited effectiveness of outdoor spreading. And one approach has been used in some places is targeted indoor residual spraying. It is a different type of spraying than spraying done with malaria, different areas of the house. But there may be efficacy there. That is a laborintensive and complex area and underlying all four of those critical approaches is rigorous surveillance for where the mosquitos are and which insecticides they may be resistant to. We have those stunned ddies now way in puerto rico. We dont know the resistance yet. In relation to poverty is one of the things well be studying in the case control study. If there is a causal association, we dont yet know which trimester of pregnancy is the highest risk and wlin that, whether it is all pregnancies or a small proportion of them that are affected. And if it is fewer, what might be the risk or protective factors. Thats a critical thing that were investigating now. Thank you, mr. Chairman. Let me just address the question of mother to child transmission which is really important. The major difference between mother to child transmission and the advances that weve had made with hiv aids and the particular challenge of zika infection in a mother and the transmission to the baby is the chronic nature of the virem pichia. We know when you bring that level in the mother to below detectible level you dramatically decrease the likelihood the mother will transmit to the baby. Because you have a lot of time because it is chronic. When you are dealing with an infection like zika, which is a flash infection. It comes, it is a few days, and then it is gone in the person who gets infected. The way to prevent mother to child transmission is exactly what we did with the rubella model. You recall that in the 60s, there were 20,000 cases of congenital rubella syndrome in the United States. Thats astounding. 20,000. Leading to blindness, deafness, heart disease, mental retardation and other types of congenital abnormalities. If you look at the curve of the epidemiology, when we instituted the rubella vaccine, it was really essentially targeted everyone, but it was specifically targeted to women of child bearing age because rubella is a relatively mild disease, very similar to zika. So i would answer your question about mother to child transmission the best way to do that is get an effective vaccine and make sure in the target countries women of child bearing age are protected by a vaccine. Mr. Chairman, i would like to address two of your points, one on nutrition, and the other on children with microcephaly and disabilities. We fully agree. We just yesterday were having a review of our nutrition portfolio. 1,000 days have been the way in which our work has been best framed. Those 1,000 days seems to be crucial, crucial both to the prevention, because as you said, malnutrition will expose you to severe infection and thus the complications you may be seeing. Malnutrition may play a role itself leading to undernutrition utero and other complications and the like. The experience in the world in nutrition around the 1,000 days also bring to bear the measurement of the head for example is something we need to do better. We need surveillance and reporting system that allows to do such and the experience and the Community Levels we have in nutrition can be mobilized in this regard. As you know, we have been very successful with child survival. 100 million childrens lives have been saved in the last 20 years. In a way we are looking to the end of child maternal development to survival to well being. We Pay Attention to many of the factors for nutrition education. Disability is very important and the u. S. Leadership is in that space for americans but also in the u. N. Theres been an awakening of the importance of paying attention to support for children with disability. The experience we have built on hiv and more recently on ebola in terms of those who are affected in terms of education on the stigma, medical care and research as to what would be the spectrum of the impact of these phenomena today and social work to support those families. There is a lot of needs. We do a center for children in usaid thats been working in this area. We look forward to continue to work with you. We will have all of these to mobilize in a region that we have, in a way, not been as present because of the success in development of this region. Weve moved most of our resources to africa and asia where we have the most deaths in child health as well as aids and tuberculosis. Thank you, mr. Chairman. Im try to keep my remarks tight. Weve got a number of members. Dr. Frieden pointed out, the difficulty of Vector Control with this particular mosquito, obviously thats one of our primary tools, but again not as easy as with certain other types of mosquitos. Dr. Fauci, you touched on the importance of developing a vaccine and perhaps the rapidity of developing that vaccine. Youre pretty optimistic that we might be able to develop something fairly quickly. Expound. Let me explain that so that its clear. In general, vaccines take anywhere from three to eight years to get all the is dotted and ts crossed full safety and approval, be approving efficacy. We have the advantage that you already need, the candidate vaccine platform. So if you look at the timetable, you always know that in vaccinology you have to be careful that things can slip. But we feel pretty confident that well have enough construct to do preclinical tox by the summer with i means we could start a phase one trial say in august. He they usually take three to four months which means well be finished by the end of 2016. Now the critical issue, if it is safe and immunogenic, and the outbreak is still raging, then you could go into an accelerated phase 2a, 2b, which means you could likely determine if it is effective within six to eight months. And if it is, you can get an accelerated approval from the regulatory bodies. However, if when we get to 2017 all of the cases go down, which is what we faced with ebola. We had an ebola vaccine, then all of a sudden the cases disappeared and it was difficult to definitively prove. If it goes down, then you stretch it into several years. But if im talking to you in february of 2017, and we still have a massive outbreak in south america, we likely would approve safety and efficacy within six to eight months. Are we going to run into terms of commercialization of that vaccine, wrapping up that vaccine, working with the private sector to get that vaccine commercialized and distributed. Will that be a problem . I do not think so. The reason i do not think so is because we are already, unlike other emerging infections, having calls from pharmaceutical companies, big pharmaceutical companies, very interested in partnering with us. So i dont think were going to have that problem. And again, all three of you touched on the importance of funding Global Health, the importance of funding global decemb disease surveillance. This is just another case of the interconnected world, disease is going to travel a lot faster and so forth. I would just put out there, the importance of funding and making those Funds Available and working together, this again is just we had ebola last year. We got zika virus today. Well have another infection next year an again. Id emphasize the importance of this funding. Mr. Chairman, ill yield back. Im not sure what your availability is to say. From will be a series of votes. We could be back in 15 or 20 minutes. Would that be okay . I deeply appreciate it. We stand in brief recess. Today, a house subcommittee is getting an update on the zika virus, the mosquitoborne illness suspected of causing birth defects. Were listening to testimony today from the cdc director, tom frieden, and nih Infectious Diseases director Anthony Fauci. Both are part of the panel of witnesses appearing before this house subcommittee today. The house of representatives itself in a series of votes, so the committee is taking about a 15 or 20minute break here. We will continue our live coverage on cspan3. While we wait for the hearing to resume, were going to show you the Opening Statements from the panel of witnesses from earlier at this hearing. I want to start at the outset with some basic facts. First, we are quite literally discovering more about zika every single day. Were working around the clock to find out as much as we can, as quickly as we can, to inform the public and to do everything that we can do to reduce the risk to pregnant women. Zika is new, and new diseases can be scary, particularly when they may affect the most vulnerable among us. Right now the most important thing for americans to know is this if youre pregnant, we recommend you not go to a place where zika is spreading. And if youre pregnant and you live in an area where zika is spreading, do everything you can to protect yourself against mosquito bites. The 80s mosquito that spreads this particular virus is very hard to control. Its a very important point when we think about what we can do to respond to zika in the short term and in the longer term. Cdc is working 24 7 tho get more information. We elevated our level of response on monday of this week to level 1 after our activation of our Emergency Operation center last month. We are committed to continuing to share information as quickly as possible with the public and with Health Care Providers and policymakers so that people can make the best possible decisions about health based on the most recent and accurate data. We will also continue to provide and update our guidance as soon as we know and learn more. This is the latest in a series of unpredicted and in many cases unpredictable Health Threats, and it emphasizes is how crucially important it is that we continue to strengthen the systems that will find, stop and prevent Health Threats wherever they emerge around the world, both to help other countries and to protect americans here at home. I want to start with what we know. As you said, mr. Chairman, the virus was first identified in 1947. It was first identified to cause an outbreak in an outbreak that the cdc scientists investigated in 2007. It is believed to cause no symptoms in approximately 80 of the people infected, and mild symptoms in virtually all of the rest. The mosquito that spreads it, the 80 species this is a very challenging what we call disease vector to control. It is an indoor biter. It bites all through the day, including at dawn and dusk. It hides in closets and under tables and places that are hard to get to. Its larvae or eggs its eggs can be be drought resistant and can persist for some time. And it can bite four or five people in the course of one blood meal, meaning it can spread disease quite quickly. Our efforts to control it are challenging. Its hard to eliminate. I want to show a bit about what has happened in recent years with dengue and chikungunya. These are two viruses spread by the very same mosquito as zika is. In red on this map you see the approximate geographic distribution of dengue around the world. You see that its widely distributed in that eckuadorial band and above and below. Chikungunya is spread by the same mosquito. It is a word that means bent over with pain. So it can cause a severe painly disease. Dengue of course can be very severe or fatal. And for more than 60 years chikungunya was present in other parts of the world but not in our hemisphere. But over the past few years it has spread widely within our hemisphere. And these are the current known places where both dengue and chikungunya have been documented to spread. Anywhere either of these diseases is present, zika may well follow in the coming weeks, months and years. Now, on microcephaly, this is an extraordinarily unusual event. I want to emphasize that. In 1941, scientists recognized rubella causes the rubella syndrome. And with the rubella vaccine, weve now virtually eliminated that in the u. S. In 1962, scientists identified m megalo virus, another cause of severe fetal malformations. In the past 50 years were not aware of anier w any other vira of a significant number of birth defects. In fact, were not aware of any prior mosquitoborne cause of fetal malformations if in fact this is confirmed. Guillain barre syndrome, which youve heard about, are a weakness of a infections, is a recognized complication of many different infectious processes, both bacterial and viral. It can occur in 1 in 1,000 or 1 in 100,000 people who have had an infection. And it increasingly looks like it is associated with zika virus infection as a postinfectious complication and it can be severe. But the big thing thats different here is the microcephaly. Next id like to talk about what based on what we know today is likely to happen over the coming weeks and months, and what were doing about it to protect americans. First. We will discover more each and every day. Ill show you later today some new data that was just released within the past hour. Well learn about maternal to child transmission, about in he possible cofactors such as other infections or nutritional factors that may increase or decrease a womans likelihood of having the zika infection transmitted to her fetus. Well learn more about the relationship with both microcephaly and Guillain Barre from studies that were doing today with partners in brazil, colombia, puerto rico and other places. Well develop better diagnostics. Currently we can diagnose the active zika infection. If someone is sick with zika, we can find it in their blood. But if it is a couple of weeks or couple of months later, figuring out if theyve had zika is very complex. And cdc scientists have worked for years to develop a seralogical test. We have a test but it is one that can have false positives for prior infection. Well learn more about the level of risk, whether symptomatic zika is more likely to cause other Adverse Health outcomes than ate symptomatic zika. Well learn how long a man infected with zika may continue to harbor zika in semen and potentially spread it to sexual partners. Well learn more about how to optimally stop the vector, the mosquito, that spreads zika virus. And for all of these things we will need Additional Resources which is why the emergency supplemental request is so important. So one thing that will happen is well learn more. A second thing that will happen is we will see more cases among travelers to the u. S. Some of them will be pregnant. Thats why weve issued travel advice not to travel if youre pregnant. And weve worked with doctors and clinicians and others to provide that advice. Third, we will likely see significant numbers of cases in puerto rico and other u. S. Territories where there may be intensive spread of zika. This is a particularly urgent area. Id like to show you a series of slides that show what happened in the chikungunya outbreak a little over little under two years ago. In may of 2014, may 5th of 2014, the first chikungunya case was identified in puerto rico. By two weeks later it had begun to spread, and each of these slides is a twoweek period. Two weeks later, two weeks later, two weeks later, two weeks later. And by october, it was in almost all of puerto rico and has now infected at least onequarter of the Adult Population in puerto rico. So this can spread very rapidly in a population. We will move rapidly to support pregnant women and reduce the risk that pregnant women will become infected, to monitor and reduce mosquito populations to the greatest extent possible. And the next thing that we may see happen is cases or clusters of in part of the u. S. That have had dengue clusters of in the past. Thats why we need support for local mosquito surveillance and control measures. We may also see sporadic cases elsewhere in the u. S. , and of course, unfortunately, continued spread around the world. To finish, what were doing now is in a whole of government way but with hhs as the lead looking at what can be done to reduce the risk to pregnant women. And the cdc part of the supplemental request is 828 million to scale up prevention, both for pregnant women, for reducing the risk of mosquitos, to prevent transfusion, organ transplant or other what we believe are rare potential forms of it transmission, and in the future with nih in the lead, vaccination. To detect through Laboratory Tests. Cdc laboratories have developed the diagnostics being used in this country, and we are working around the clock to get these diagnostics out so that more people who want to be tested can be tested. Well improve clinical diagnosis in reporting mosquito surveillance and including the resistance of mosquitos to insecticides which is very important to know so we can target our actions. And could understand microcephaly more. Within the past hour, cdc has released information from brazil on the findings of among four infants, two miscarriages at age 10 and 11 weeks, spontaneous miscarriages, and two infants who tragically had microcephaly and died within the first 24 hours of life. Working with our brazilian colleagues, the cdc laboratory was able to identify the genetic material of the zika virus in the brain tissue of the two infants who died with microcephaly. This is the strongest evidence to date that zika is the cause of microcephaly. But it is still not definitive. Well still into ed to understand the clinical an epidemiological patterns to make that link definitive. To do these investigations and to do the response, we will need Additional Resources. Vector control is complex and expensive. There are a series of measures we can take, particularly in the u. S. Area of puerto rico and other parts that have had dengue transmission. And we look forward to working with you to inform people about the latest information on zika and what we can do to stop it. So thank you very much. Dr. Frieden, thank you very much for your testimony. Dr. Fauci. Doctor, thank you very much for your testimony. Thank you very much, mr. Chairman. Chairman duncan. It is a pleasure to be with you this afternoon and to discuss with you the Research Conducted and supported by the National Institutes of health in addressing the zika virus situation that we currently find ourselves in. It is important to point out that we are part of a government wide and hhs concentrated effort with our Sister Agency cdc, fda and others within hhs, who address the Public Health issue of zika and our role is in the area of basic and clinical biomedical research. As shown on this slide, the National Institute of allergy and Infectious Diseases, the institute that i direct, has a dual mandate and the mandate is to not only in the classic way support a robust, basic and clinical Research Portfolio in microbiology and Infectious Diseases, but simultaneously to be able to respond almost immediately to a new and emerging threat. The situation we find ourselves in right now with zika. As i wrote in this article just a few weeks ago in the new england journal of medicine, zika virus in the americas, yet another arborvirus threat. The point i made in this article, if you look just in the americas notwithstanding the rest of the world over the last few decades what we have seen is an explosion of dengue but new viruses that had never before been seen in the western hemisphere. Dr. Frieden mentioned a couple of those. West nile. Chikungunya in the caribbean and now zika in the americas. These are mosquitoborne viruses that have the capability of spreading very rapidly. What weve been able to do, and im going to describe a bit of that for you, and obviously leave time for questions later, of what the approach of the nih and niaid has been. Our major mandate has been to provide the basic understanding of disease, the clinical research, resources for researchers throughout the country and the world, as well as Biotech Companies, with the ultimate goal goal in developing what we call our countermeasures in the form of diagnostics, therapeutics, and vaccines. Lets take a very quick look at some of these and how they relate to the situation with zika. Dr. Frieden mentioned the issue of epidemiology and natural history. We have our grantees and contractors who have been studying similar diseases like the dengue virus to try to understand what we call the natural history. What is the difference between symptomatic and asymptomatic disease. As what is the relationship, direct or indirect, alone or synergistic, between an infected pregnant woman and the development of congenital abnormalities like microcephaly. What indeed is the Broad Spectrum of the pathogenesis of microcephaly. All of these are questions were asking alone and together with our colleagues at the cdc to try and get quick answers to them. If one looks at the basic science, if you look at other viruses that we have been studying hiv, influenza, or even ebola because of the effort in trying to understand the fundamental molecular virology, we need to do the same thing with zika, studying the viral structure. Studying the outbreak in an island, in french polynesia. If its evolved, has it impacted the pathogenesis and manifestations of disease. In addition, well be establishing animal models and any new disease to understand pathogenesis as well as to screen for drugs and test for vaccines, animal models are critical. Dr. Frieden mentioned the issue of Vector Control. There are a number of ways to do that. The classic way, but also some novel ways which we are exploring but should not take the place of the classic ways, and that is things like the again nick manipulation of mosquitos or infection with other bacteria. Again to emphasize, this is not an easy thing to do, as dr. Frieden has emphasized. Vector control is a very important tool, but it is not easy to implement. We mentioned diagnostics. The cdc is taking the lead on that, but our grantees and contractors are using some of the knowledge gained from our study in chikungunya, in dengue and other to get more precise state of the art point of contact specific diagnosis so we can tell a woman, who may not know whether she got infected, whether she actually had been infected with zika during her pregnancy, or before. Importantly our role in the development of a vaccine is actually encouraging news. The reason i say encouraging, is because weve had positive experience with the development of vaccines for other viruses. Case in point dengue, in which there is already an approved vaccine in brazil and mexico, and weve started last month a phase three trial of dengue in brazil in collaboration with the institute of butantan. In addition, west nile, another one of those viruses, we successful made a vaccine. Unfortunately, even though we went through phase one with good safety, we could not find a Pharmaceutical Company that wanted to partner with us because it was felt that this was not something that would have a good profit because of the target population. I dont believe at all that we will be left with this problem with zika since we already have a considerable amount of interest on the part of pharmaceutical companies. Were going to use the same technologies that we use to develop the vaccines for other viruses and were already manufacturing the what we call the construct for that which will make to the point of gnp and get into a phase one trial i would think, and almost be certain, by the middle of this summer, which would be asking for safety and immun hoch immungenicity. This is whats called the dna construct in which you insert the gene first of west nile well just substitute is and stick the gene of zika in, inject it into an individual which would produce now vie valuelike particles which we know are safe and we know theyre immunogenic. And therapeutics, since it is not high on the priority since it is a transient infection and we have to do a lot of screening, we nonetheless are looking very carefully with our Drug Screening capability at possible therapeutics for the entire class of those viruses. I want to close with this last slide which reminds us of something that i said at the very beginning of my presentation, that microbes have emerged, are emerging, and will continue to emerge. And i refer to it as the perpetual challenge. We know were talking about zika today, and next month or next year well be talking about Something Else, in the same way as last year we spoke about ebola. Hopefully and i know i want to thank the congress for the support that youve given us over the years to allow us to address these problems. Thank you very much, mr. Chairman. Be happy to answer any questions. Dr. Fauci, thank you very without much for your testimony. All of your full statements which are very lengthy and detailed will be made a part of the record. Id like to go to dr. Mendez. Thank you, chairman duncan, Ranking Members and all the distinguished members of the committee for inviting me here to testify on the United States agency for International Development, usaids response to the serious concerns raised by this spreading in the americas of the zika virus. I want to recognize the leadership of my colleagues, dr. Frieden and dr. Fauci, that have been rapidly mobilized in the response and immediate investigation that we already are learning a lot. But as we have learned from other outbreaks, we cannot wait to figure all out before we begin to have this discussion and response. On monday the president submitted a fiscal year 2016 supplemental request to respond aggressively to the zika Virus Outbreak. The supplemental request includes 335 million for programs to be implemented by usaid so that it can help countries affected in the region by zika respond and protect their citizens and in doing so prohibit eliminate the spread to our homeland. Let me describe the proponents of the work we propose by usaid. First we will support Risk Communications and behavior change programs. Getting the right information to the people, empowering people with the right information. This is going to be a rapidly evolving field. We dont want panic to take place in the region as we actively take actions to help people protect themselves from the zika as well as other mosquitoborne diseases. This include mobilizing communities on Vector Control, providing clean information for women concerning the risk of the zika virus and pregnancy and how to protect themselves. Community level messaging will be combined with mass media and social media campaigns. We will also partner with the private sector and are in discussions with companies in brazil at this moment to help us do that. Second, usaid will support implementation of a package of integrated Vector ManagementVector Control activities in communities at risk of zika. This will help reduce exposure to mosquitos and will take protect against other vectorborne diseases such as dengue as we heard just now. Specific activities will include Community Mobilization campaigns to reduce or eliminate standing water sources where mosquitos breed. Vector mapping to eliminate major breeding sites and win door and door screening to reduce mosquito entry into homes, schools, hospitals and workplaces. Pressures we have today are not optimal but they have been shown to work in a number of settings and we will certainly work with our partners in developing new tools. As we do we want to make sure they been available rapidly in the region. These efforts will build upon the foundation of experience of the successful Malaria Initiative aware that the zika virus is carried by a different mosquito, we have expertise in mapping, expertise in entomology that can be brought to bear in response to zika. Thirdly, usaid will help ensure women in affected countries will have access to Proper Health care and support. This will include training of Health Care Workers to provide advice, provide support for pregnant women including them access repellant to protect against mosquitoes and access to Family Planning as we hear from mr. Duncan. This will be important to have information, to have services, to have methods, and as well as the care of the affected newborns. I know that the chairmans always had a concern for the newborn. Finally, innovation. We can take steps to spur 1re7 development of new tools and other innovation to enhance response and prohibit future outbreaks. The research nih leads is significant. Our partners at cdc are supporting this Critical Research already and we need to better understand the virus and the relationship with birth defects and developing new tools. As we have learned, the markets need to be incentivized, need to be organized. And markets can be significantly important to help us bring those tools to fruition and to quickly deploy them in the region. Market incentives can be used throughout the Development Process from cataly didding Early Stage Development of diagnostics and vaccine and Product Manufacturing and scale. In response to the ebola epidemic, usaid used grant challenges to rapidly source new innovations to address key gaps in our response. We are planning also considering new grant challenges to bring new ideas to bring the private sector and diagnostics back to control. Mr. Chairman, zooek, zika, mrsa, sars, influenza and ebola all point to a landscape interaction between humans, animals, vectors is constantly changing. For our civilization in the first time we are seeing a explosion in the tropical regions of the world and increasing need demand. Urbanization changes in Global Travel and the like. Ecological transformation and climate weather pattern change are increasingly interconnected in our world. That means mosquito borne diseases such as zika can appear in areas they hadnt before. This rapidly changing dynamics means we have to be prepared for what is seemingly unpredictable. A recent report from the National Academy of medicine of global risk framework estimates the annualized cost of pandemic risk is 60 billion a year. Other estimates are actually higher than that. So we need to make sure that we are prepared because both the cost of life and the cost in the economy is likely to grow in coming decades. As we address the immediate needs of the zikaaffected population, we must underscore the need to improve National Systems to prevent and dictate response to these pathogens. I think this is the effort at the heart of the Global Health security heart of the Global Health security agenda launched in early 2014. Were back live on capitol hill. This house Foreign Affairs subcommittee hearing about to resume with an update on the zika virus. Were hearing today from cdc director tom freiden and nih Infectious Diseases director antho Anthony Fauchi among the other panel of witnesses. Live on cspan3. The subcommittees will reconvene and as soon as my colleagues do come since ive already had my turn, i will yield to them. But i did ask the question earlier and maybe if you could just elaborate a about on it and that is the capacity, the actual volume of potential pesticides. I know, dr. Freiden, you talked about the utter importance of draining sitting water. And i know even in the big island in hawaii theres just a new emergency call because of dengue to go after spare tires that are housing water and becoming breeding grounds for mosquitos. And, you know, i get that. Thats labor intensive but not necessarily, you know, doesnt require chemicals per se. But what are the actual pesticides that are considered safe and what is the potential supply of those . Thank you very much. Im glad you came back to that because i wasnt able to address some of the really Critical Issues there in my earlier reply. The u. S. Capacity for Mosquito Control is quite variable. So, some parts of the u. S. Do this extremely well. Some parts not so well. And one of the critical components of the supplemental emergency supplemental request is to strengthen Mosquito Control in the parts of the u. S. That have mosquitos that could spread the zika virus. And here we look at a comprehensive approach. So, on the one hand theres the things that you can do to reduce larval populations and the use of bti and two different bacteria that infect and kill the larval are very effective and used pretty widely not just human health but agriculture and on other ways. There are other ways to reduce the population, but thats one of them. For the adult mosquitos there are three broad classes of insecticide and within those there are many different types of insecticides. Not all are licensed for use in the u. S. And were looking very carefully at whats been done in other countries including australia with targeted indoor residual spraying of insecticides and seeing what would be safe and effective here. So thats something that were in frequent discussions with Industry Partners as well as epa and other entities. But there are issues of what we could do thats safe and effective. The Mosquito Control efforts are also more than just chemicals. Its about having a surveillance system. Cdc has invented a type of trap which is currently in use in california and elsewhere that can monitor what the mosquito populations are. Cdc laboratories have developed a simple way of testing for Insecticide Resistance so that we can get a better sense of which should be used, because we are seeing reports of Insecticide Resistance and then looking at where the mosquitos are and what insecticides theyre susceptible to. We would proceed with recommendations for Mosquito Control. But this is all quite labor intensive. It needs to be done in the same way that you need a Public Health system to stop, find and control problems and you need a mosquito Vector Control systems to track where they are and respond in real time. I appreciated usual comme ed on the rush to get to a safe and effective vaccine. As you pointed out in your testimony and comments and i heard you on the radio talking about this recently, it may not be through the normal channel but we are in an emergency. How quickly could such a vaccine be available . So, if you thank you for the question. If you go to a continually emergent situation and all things work well, if we finish the phase one trial as i predict we will by the end of 2016, and we still have literally thousands of cases into 2017, you could go into an accelerated phase 2a, 2b which if you do the math and the statistics depending on the number of cases and how effective the vaccine is in anywhere from six to eight months you may be able to show that it is, in fact, effective and safe. At that point, even though it would take maybe a few years to get the ultimate final stamp of approval, there is a mechanism of accelerated approval and accelerated access that you could implement if, in fact, you have a good safety profile and youve shown efficacy. So, you could conceivably have it by the end of 2017. Which is really rocket speed for a vaccine. Can i just ask anyone who would like to respond to this, there are about 25,000 children and adults with microcephaly today in the United States. Obviously there are support groups. Theres a great deal of knowledge that has been gleaned from their experiences and as i said earlier, you know, the spectrum, you know, its not unlike maybe its not a good comparison but it reminds me of the autism spectrum. The fact that there are people that are severely atistic and some that are highly functioning. And i wonder from those groups like Boston Childrens hospital which has done wonderful work in that area, are you looking to tap that so that we share best practices with these countries which may not have that experience . Yes, thanks for the question. As you know, mr. Chairman, from your past work, the centers for Disease Control and prevention includes the National Center for birth defects and developmental disabilities. And in our Emergency Response there are fully integrated including clinical j geneticist and we need to learn more about the spectrum in this case. As noted we may well see a Broad Spectrum of some more severe, some less severe and this is something that we want to provide all of the expert assistance we can to support women, families and communities that are dealing with this very challenging situation. Yes, doctor . One of our partners in the Birth Initiative is emory Pediatric Association and they can help us bridge domestic lessons to the programs we are deploying internationally. I appreciate that very much. Id now like to yield to the distinguished chairman of the western hemisphere committee. Thank you, mr. Chairman. A lot of folks traveling to brazil this summer. What steps are being taken in brazil that you can tell us about . You know, weve even heard calls for canceling the olympics. Because people are concerned. So, what are the brazilians doing . What are you doing to help . And what do we need to know . So, brazil has taken this very seriously. They consider it i think an absolute Top National Priority and as the chairman mentioned, the other chairman mentioned in his opening remarks, they have deployed hundreds of thousands of people in the response. Theyre working to reduce mosquito populations. Theyre trying new forms of Mosquito Control. They point out that the season of the olympics is a cooler season so generally has less mosquito activity, though, not none. But i think from our standpoint at cdc our role is to give travel advice to people, regardless of why theyre traveling. Whether someone is traveling for the olympics or any other reason our advice would essentially be the same. And from the very first days when we had strong evidence suggesting a link between the presence of zika virus and microcephaly, weve advised that pregnant women strongly consider not going to a place that has zika spreading, so that is our advice from cdc and that for women who live in such areas or people who go there, to take really good steps to prevent mosquito bites. And things you can do applying deet multiple times a day, mosquito repellant, wearing long sleeved shirts and long pants. Using clothing that has treatment so that it repels mosquitos. And to the extent possible staying indoors within airconditioning and screen or at least screened and enclosed spaces. And i think as we learn more in the coming weeks and months more will be understood about what can be done to keep any risk that might be there to the absolute minimum. I think it will definitely smell like deet down there sure enough. So, i was in peru, theres a mosquito and Dengue Research project going on. And tracking individuals that may have been contracted and where they have traveled to and who else may have been exposed or mosquitos in that area. A lot of folks in my district are concerned, mr. Chairman, about unaccompanied children coming north from lat latin ame. Its been an issue and now its been exacerbated with zika. Do we need to know anything . How prevalent is it for a child, a minor, to carry a disease . I know you said its got a very short period where its symptoms are prevalent. But are we researching how long an adolescent would carry the disease and whether, you know, say, they come north of the border and are bitten, do you see where im going with that . So, what do we need to know about that . Weve studied this in a variety of prior outbreaks as have others. The virus stays in the blood for about a week after people begin to get sick. We dont see longterm persistence, unlike, for example, hiv and hepatitis which can stay in your blood really for life, this is a shortlived a virus that doesnt persist in the blood beyond a week. And if you think about the numbers, theyre really quite striking, but theres a lot of travel from americans going to central and south america and the caribbean on the order of 40 million visits per year. So, lots of travel. And if you think about the different types of travel, thats a very large number compared to a different type of risks. The one area i would just to give full information, what we dont yet know is how long the virus can persist in semen and were doing studies on that. But thats the one area where we might see the potential for transmission through sexual contact for more than a week. And we wont know until we do the studies. Thats why weve recommended that for men who have sexual contact with women who are pregnant that to avoid the transmission of zika. You mentioned that earlier. I get that. So, when Ebola Outbreak was happening, we were doing airport screening of folks who had traveled to the african continent especially those three main countries. Latin america travels much broader than that. Is there any proposal or any talk about doing airport screening for potential symptoms that you know of . Yeah, as you point out, the situation is very different. We have roughly 20,000 visitors versus 40 million. We have a disease which is spread from person to person in the case of ebola, whereas its not with other than the rare sexual other than sexual activity, right, right. So, i think the situation is really very different in terms of zika and our goal really is to protect pregnant women. Thats the key priority now. Right. So, we have an el nino going on. Its very wet across the south. The amount of water ive seen in arkansas and louisiana and texas, South Carolina and alabama, mississippi, North Carolina means that theres going to be a lot of standing water in the south this year. That means mosquitos are going to be very prevalent whether they are the no seeum variety or the tiger type you mentioned. This is a core component of the emergency supplemental request. We would be issuing to grants to states at risk and Southern States as well as u. S. Territories to better control mosquito populations. Right. I think historically thats been a Winning Strategy against malaria and other with mosquitoborne viruses. Well, listen as someone who chairs the western hemisphere subcommittee who will be continually focuseded on this who may see congressional travel in that area, individual congressmen are going to be concerned that, you know, theyre wanting to know what level of information we have and how can we allay their fears and the general public that continually travel in that area. This has been very helpful, mr. Chairman, and with that ill yield back. Thank you very much for your questions and for this collaboration of the two subcommittees. Id now like to yield to the gentleman from staten island. Thank you, mr. Chairman. And thank you, panelists, for sharing your expertise with us. And welcome, my friend, tom freiden, its been a long time. I look forward to visiting you in atlanta. Thank you for all the work you did for the people of new york city when you were Health Commissioner there. I think we were fighting west nile at that time. It was in its infancy stage in new york when you were the Health Commissioner. I know that you need more resources. Until we figure that out, is there an ability for you to redirect some resources that you have to address this . Well do everything within our power to address the zika challenge. But the supplemental calls for 828 million for cdc in three broad areas. Emergency response in puerto rico, which has a significant risk of seeing widespread transmission of zika. Support for the continental u. S. For states at risk including Mosquito Control diagnostics and a series of other measures and then international support. While we can get started with that, we cant do it at scale to the level that we would need and weve already had to curtail some other activities such as our activities that deal with lime disea lyme disease. I ask that weve only passed the 21st century cure act to fund cdc and nih to come up with remedies and vaccines for some of the diseases that are known in the world. I also realize that it takes a while even after youve done your work for the fda to approve a lot of these things. Is there any mechanism in place, tom, that we could help you speed that up whether its through legislation or something of that nature . Weve been working very closely with the fda on both ebola and zika theyve been able to rapidly allows us to use effective test technologies within a day or two of us asking. Thats worked very well. We really want to tip our hat to the fda and what they helped us with, with ebola. When we really needed to get the vaccine trial out quickly and go from a preclinical to a phase one without cutting corners of safety or anything, they greatly expedited to us to get the phase one trial done here in the United States and in europe and in africa. And then we went into a phase two trial. So, were working very closely with them right from the getgo. And one of the really productive interactions you have is that you involve the fda right from the very beginning of a project. You dont do it and then go to the fda and see how you can get something approved. They work with us right from the beginning and thats exactly what theyre going to be doing as we start developing things like vaccines for zika. So, were very optimistic about that relationship. Thats very comforting. The last comment i have is dr. Fauci i was displmayed that you worked so hard to find a vaccine i think it was for west nile and that no pharmaceutical wanted to produce it because there wasnt a profit. All you doctors take a hippocratic oath to serve people. Im just dismayed, but thank you for sharing that with us. Youre welcome. And that is frustrating for us because we think in terms of whats good for the Public Health and the Global Health. And sometimes when you get involved in things that are profit developing, that that comes in and gets in the way of that. Having said that, i feel confident that from the indications were currently getting from pharmaceutical companies that we wont have this problem with zika. So, we should be blessed that theres a profit in the zika virus. Well, unfortunately thats a perverse way of doing it, but youre quite correct. Thank you. Thank you. Let me add, the region may have more resources but also we are also exploring financial mechanisms that we had used in the past for vaccines where market failures prevent the final development by the companies and we have an experience with the vast Market Committee that has been done through the globaleal alinings alliance which allows production at scale for the pneumococcal vaccines for children. The chair recognizes mr. Claussen. Thank you for coming again, guys, ill ask for quick answers and i have several questions and i think people are ready to go, okay . First of all, its the same mosquito that does that carries dengue, chicken gunga and zika much of the time, is that correct . Thats correct. Is anybody thinking about a genetic therapy fix here . I mean, i dont want frankenstein mosquitos, but it seems to me that you get the trojan horse and the soldiers inside the trojan horse are going to die with it. And so as i thought about my own legislation for this obvious problem being from southern florida, it seemed to me that genetic fix ought to be something that is thought about and if you all tell me its practical, then with my team im going to keep pursuing what we can do legislatively to motivate that. You all are in agreement with me on that . Its a promising technology. The biggest challenge is scaleability and community acceptance. Agreed. But Multinational Companies work all over the world and that acceptance factor might be different as we get closer to the equator. You would agree with that, too, right . Because you got a bigger outbreak, you got a bigger problem. Okay. Thank you for that. We have vaccination for dengue in brazil, right . Correct. I know they were working on one in Southeast Asia for a long time. I dont remember where it got. Do they go quicker on this sort of thing to get vaccines in brazil . Would americans worried about dengue fever, should they go to brazil for a vaccination or are you all are you all hesitant about, you know, the safety of this . It just seems like the obvious question. No, actually its a good question. There is an approved vaccine by mexico and brazil for a dengue vaccine. Thats about 60plus percent effective. Theres four different types of dengue to my you are correct. Is that if you get a vaccine for dengue fever in mexico, is would it be would it work in india . Its a different strain and sometimes a different mosquito. Its the relative proportion of the sera type thats dominant in a particular area. The one that didnt quite get off the ground in asia didnt have a good protection against evenly all four sera types. The one thats in brazil now. And im saying that so, it works better with whatever the mosquito here is and maybe the one adjacent. Right. Thats closer in the serum as you say, right . And we actually have a phase three trial thats ongoing that started just about four weeks ago in brazil in collaboration with the institutes that the nih is actually running the trial with them. Is anybody working in asia now so that if somebody gets off a plane during the rainy in the monsoon in india they dont bring a different strain to mexico or brazil . Well, i dont think its a question of a different strain because you have four sera types they are essentially universally seen all over. So, even in india there will be all four. Rather than one strain or the other its the one thats dominant. Got it. Sera time two is the one of the most problematic ones. Got it. Okay, look, for me thats a big deal. Ive had break bone fever and i dont want number two and have hem mowragic type. You got it. . A world of International Travel the second time is worse. Im in the 50 and older crowd, right . Which makes my liver even more susceptible to swelling so, you know, we also have to think about the Global Nature of this. Am i right about that or am i missing you are. Okay. Do you you know, my idea our idea legislatively was, you know, we could always get use government money here. It seems to me that as long as to mr. Donovans point, as long as Drug Companies see a profit motive and im always worried about that with zika because ive got one of the few districts that might be actually impacted here. Its not going to get impacted in new hampshire, right . But it could be impacted in my district. Naples. Nonetheless, i mean, if we gave somebody tax credits for their r d in order to expedite research into, you know, battling this virus, or coming up with a vaccine, you see any downside on that . Trying to acsell rate the private sector to jump in the game here . Because it feels to me like they set out dengue fever. It feels like theyre sitting out chicken gunga and we dont want them to sit out zika. Am i right about all of that . Incentives to pharmaceutical companies are often helpful in getting them engaged. We have another way to incentivize them which is what we do at nih. We do what is called derisking. We do a lot of the work that they would otherwise pay for themselves. So their investment risk is less. Some Companies Take the vaccine from the concept to the product. They dont need anybody. They dont need the nih, they dont need anybody. But when something is a Public Health imperative and theyre not interested and if we push the envelope to the point that, here, we know this product is good and its safe and they are much more enthuse aiastic about getting involved because we made a major investment. Thats a good way to incentivize them. Can i have one more question, mr. Chairman . One more question. So, we always think about these diseases as if they were malaria which means outdoor, nighttime, you know, these are indoor, daytime mosquitos and so spraying whenever i see the spray trucks, i say, thats a wasted bullet. On the other hand, in our country and in my district we dont have as much water sitting around, freshwater sitting around like you would find in the caribbean or in brazil. If we do a good job on making sure we dont have a lot of pooling water around, is that enough . Are we going to be oknt