Transcripts For CSPAN2 CDC Director Public Health Officials Testify On Monkeypox 20220915

[background noises] [background noises] [background noises] [background noises] [background noises] [background noises] good morning. The Senate Education and labor and pensions given it come to order. Today we are having a hearing on the federal response to the monkeypox outbreak as we work to stop the spread of thisr virus. I will have an Opening Statement followed by senator and then we will introduce our witnesses. For restart, i want to take a moment to congratulate one of our witnesses, dr. Fauci on announcing its upcoming retirement. Dr. Fauci, you have served through multiple decades and president s. And Public Health threats and work to save countless lives. I hope you know you have the thanks of a grateful nation for your Incredible Service to this country, so thank you and thank you for being here today. So, after the witnesses give their testimony centers which have five minutes for round of questions. While we are able to have this hearing fully open to the public and media for inperson attendance my video is available on oures Committee Website help. Senate. Gov. If anyone is in need of accommodations including close captioning, please reach out to the committee or the office of congressional accessibility services. According to the senators entrance centers for Disease Control and prevention the u. S. Now has over 21000 confirmed cases of monkeypox. More than anyone else in the world. My home state of washington has over 500 cases. I have heard from families who are rightly concerned about how bad this is gotten in a Public Health officials including a back in state who are frustrated to see the response run into issues we should be prepared for by now for that is why i continued to push the bite administration about my concerns with the monkeypox response and urge quick action on testing, on treatment, on vaccine and unclear guidance to the public to our Healthcare Providers and state Public Health officials. It is reassuring to say we are making progress on testing. Capacity is increased thousand fda just approved a faster track for additional tests. On vaccines, bert is helping stand up a new vaccine sites in michigan. Hhs is working to expand the number of Distribution Sites in the states the Administration Advice for splitting doses has greatly stretched over a vaccine supply. On outreach, the ministration started working with states to make Vaccines Available at events with many people from Lgbtq Community in attendance. Perhaps most importantly, the rate of new cases is going dow. Now that its all encouraging news. But let me be clear, we must remain vigilant in our response. These promising improvements do not excuse the issues ive beenn hearing about from communities, from state Health Officials and advocates from the very start of this outbreak. Patients have spoken out about how hard it is to get tested. Some even waited days despite having clear symptoms. Providers have had to jump through hoops to get their patients treatment. And i am cussing talk to Public Health officials in my state who have told me how communication with state could have been far clearer and faster. How the challengesns in accessig text and maxine have delayed their response by no states have especially struggled with the federal governments decision to forgote the system we typically used to distribute vaccines. The one we are already using for Covid Vaccines. When it comes to Vaccine Distribution, some shipments have been sent to the wrong states. Even spoiled after storage at the wrong temperature. Di there been issues with vaccine supply as well. Like when thousands of vaccine doses were delayed because fd had yet to inspect the new plants theyre coming from. When the bite administration missed an opportunity to procure vaccines at a Crucial Point in this outbreak. And again we are seeing in equities worse in this outbreak for some communities. Advocates and Lgbtq Community vast majority of cases have made clear they feel theyre being overlooked or in some instances stigmatized. We need to keep focusing and improving on outreach. Getting information and resources like vaccines to those who are most in need and most at risk. That must include committees of color who we know do not have equitable access to vaccines. This is especially important as early data suggests a black ando latino communities are disproportionately burdened by this outbreak. We have to do better. We need to be applying what we learn from the Covid Response in providing the resources communities have made cleari need. Of course there is an enormous difference between this and the covid pandemic, which is, thanks to decades of Smallpox Research we are, treatment and vaccine ready to go before this crisis began trade that should serve as a reminder to all of us about the immense value of investing in Public Health preparedness. But it is also why the stumbles and these tools deployed were specially frustrating and inexcusable. To learn from this, we need to be clear eyed about what went wrong. Not just the challenges we face and left several months, butbl that we have faced for decades. Challenges that to be frank spent many administration, not just this one. For example we had over 20 million vials of smallpox vaccines and our National Stockpile but they were not replaced as they expired over the course of a decade. My Ranking Member and members of this committee when i say weve got to do better. Not just on covid, not just on monkeypox but Public Healthen threats. Because we know there will be more. Just last week nork declared an emergency due to polio at another Public Health risk we need to watch closely. I would tear from our Witnesses Today not just what theyre doing right now to improve our response to the monkeypox outbreak but also how we can fix this in the long term and make sure the stumbles of the past couple months never happen again. I want to knowth you and the administration are doing to make sure we have enough tests, treatments and vaccines for this outbreak and get them where they need to go. Also s maintaining an adequate stock of supplies for any smallpox threats. What you are doing to improve outreach to the Lgbtq Community, address disproportionate harm to black and latino communities. Fight stigma and misinformation write the inequities weve seen in our response so far. How are we making the most of the noose researched about promising vaccines and therapeutics . Make them more quickly availablh while continuing to uphold the Gold Standard of safety and effectiveness. Are weakening schools and colleges everything they need to stay open and keep students in School Committee safe questar complied cdc has provided guidance for k12 schools. Fortune the science tells us Elementary Secondary School kid are not at high risk. Cdc is also released resources for colleges which is critical students returning to campus this fall. We need to make sure colleges and universities are equipped to prevent potential outbreaks of students movede into dorms and live in close quarters with each other. I really should got your work cut outed for you and all this especially with covid still raging. There is no reason for us to fall behind. Im going to keep pushing you here because families back in Washington State and across the country are counting on all of you to get it right. That is also am going to keep pushing my colleagues here in congress about the need for funding to support all this work. I know im not the only one here with concerns about the monkeypox response. We cannot just say this isnt working without providing the funding to end this outbreak and build the Public Health system it. Icans deserve ill continue to work with our colleagues on both sides of the out push to deliver the resources that will help get families the testing, treatment and vaccine they need. Im interested in hearing from the witnesses about the needs are when it comes investing her monkey pumpp response. Its important we continue give her eyes on the horizon when it comes to future outbreaks in build a stronger Public Health system. The saying goes an ounce of prevention is worth a pound ofbr cure. That starts with building a worldclass publicst health sysm rather than one that lags behind our peers. Our communities deserve to be as safe as anyone in the world which is why senator and i are contingent to work to pass our prevent packed. Implements the lessons from her Covid Response and improves our policies and processes on issues like strengthening supply chain, improving management or National Stockpile. Modernizing data system many challenges we face with monkeypox. Strong Public Health system also requires strong investment. Because her Public Health system was underfunded before covid struck it is been overwhelmed ever since. We have to end the cycle ofck crisis and complacency by making sustained investments that allow us to build and maintain a Robust Health infrastructure at all levels. How could pushing for all the steps we should all know by now just how much is at stake. I can play families in seattle know, appearance in spokane, nurses know, workers in olympia know people cross Washington State and across the country now. W. Covid was never going to be the last Public Health crisis we face i neither was monkeypox for the question is not whetherer there will be a new threat, it is when it will strike on weatherby will be ready. The truth is the monkey pox response so far as not been encouraging. There are clear signs of progress there are clear steps that we can and should take to improve. I dont to just hear about the steps she will be taking a doing to tc action. Ill be watching close of how we build together to end this crisis and make the kind ofs improvements we need to help security on solid footing onceel and for all. I think youve a much all turned over for his openingng remarks. Exit thank you men and german good morning. I am glad we are finally here, having an outbreak on monkeypox outbreak. As it hits our nation but monkeypox is now a Public Health emergency. It did not have to become one. I think the one promising thing that can be said this morning is the infection rate has slowed. That may be theg only thing sine inmate when the first transmission was reported in the uk and europe ive been pressing the administration for strategy and upland. After almost three years of the coed pandemic you the Public Health agencies responsible for preparedness and response to be prepared for anything particularly a threatt like monkeypox which we have known about for decades. And for which we have vaccines and treatments. Dr. Fauci talked to this committee before but monkeypox. Its almost a definitional case of what cdc and their sister agencies should be prepared to tackle. A virus that spreads through physical contact, a virus that spreads when an infected person has an obvious sign of infection. This is not like cold lid though stay tuned newly emergent virus that spread asymptomatic infection. But by any measure in fact by every measure the response and the bite administration a monkeypox crisis has been a catastrophic failure. He repeated each of the mistakes of the early days of Covid Response. The cultural arrogance from Public Health officials who are supposed to be the forefront of our response let this country down again. E since he covid pandemic started this committee has held 13 hearings on the response during both the trump and the biting ministration. I would think you be sick to be called to the carpet on us having to hold you accountable for systematic failures. But it seems as if nothing has changed. You cannot blame the last administration on this failure. The first confirmed monkeypox case in 2022 was inmate seventh in the United Kingdom. The first case of monkeypox in this outbreak was reported in the u. S. On may 18. We had a warning. We had morning this was coming but we should have been prepared to manage what came when it arrived. Lets review. We failedth testing. Although he eventually made Testing Available through Laboratory Response networks, these tests were too hard to access. It took weeks before doctors were able to get their patients tested without have to First Consult Public Health officials. There is alsowe significant dely in conducting with outbreak would wait until june 22 to announce engagement with the private sector. Still, after that Companies Interested in developing thison known diagnostic tests that could help address some of the slow turnaround times ande improve access had been left waiting months for samples needed to develop those tests. Without delay upon delay we failed on vaccines. Enhance strategy to at risk individuals and known contacts was announced june 28. On a full month after the uk joint committee on vaccines and immunizations met to discuss a similar strategy with their citizens. Why do we continue to be behind . Meanwhile decisions about vaccine a ministration in f the u. S. Seem to have been made seemingly onthefly. Even fda administered authorization last month allowing vaccines to be administered objections there were no Public Meetings at the fda, cdc outside experts to discuss relevant questions on the minds of impactedin americas and inform these decisions. Health professionals were confused aboutng the initial pot patients scared they were being experimented on. To make matters worse the states had no time to prepare for this change in Vaccine Administration right after fda made its decision, as to reduce statein Vaccine Allocation under the assumption every vile would yield fiveve doses. Yet you know this is not been the case in every state resulted in some vaccinating fewer, not more at risk people. Failed at having a plan. Monkeypox outbreaks have been occurring in nigeria and other places with increasing frequency. It was identified a threat under our threat matrix and the threat for which we had countermeasures in our stockpile. I might also add our earliest purchase of the vaccine in bulk was in 2017. N the policy but the priorities were varied its not clear what Research Activities hhs isk actually undertaken in response. These failures have allowed thei disease just bradford anyone cases made quickly quickly turned a 650 cases in june. More than 6000 cases in july at more than 12000 cases in august. Near 22000 so far in september. Should have been obvious to all of us the timing of the early cases coupled with evidence of cases were not linked would create a perfect storm for a large outbreak. Monkeypox is a virus that largely transmits their skin to skin contact. Most easily regally transmitted between sexual partners. Monkeypox arrived just before the pride celebrations across the country. Locked in thes of social distancing, your agency should been screaming from the rooftops about what you knew or suspected how monkeypox would spread. Instead we remain silent. People got sick because of that silence. This is not rocket science. Th consenting adults need to be told what Behavioral Changes s they should consider to avoid getting a preventable disease like monkeypox. You failed at a time when the communities most at risk needed you. Disease control and prevention and response is literally in the name of two of your agencies. Yet, you did none of that. There was no surprise to me the administration after months ofo floundering appointed a new czar at the white house to coordinate the response. Shows why this committee passed the prevent act to create a Mission Control but secretary of hhs is been totally absent. When he has been involved ithe only seems it makes matters worse. But no ad hoc groups within government are exactly the problem. We need a consistent coherent governmentwide response to be effective for that can only be led by the white house. I hope in the coming weeks we will be able to get that legislation over the finish line i will commit to spending my remaining weeks in the United States i senate doing everythini can to help the white house set up the new office with a Lasting Mission and clear agenda. If i were not retiring its in the neck servers conducting a thorough examination of each of your agencies highlighting each and everyone of the systematic and bureaucratic failures that we have seen it now and response, after response and demand accountability for the American People. D there is a question of authority. You have the authority its a question mike is not a question of money youve been given astonishing amounts of money. E its a question of leadership. It is a question of focus. Its a question of squashing typical bureaucratic roadblocks, arrogance and ineptitude. You need to do better. We learned operation warp speed when you press outside the box. When you focus on publicprivate partnerships, you get bureaucracy teams what serves thehe American People doesnt ty to control them we can make it work. I would ask you for your plan, but you dont have one. I would ask you for what you would change, by your agency seem to think theyre doing everything right. I would ask you who you are going to held accountable . Failures in each ofth your agencies show you do not believe in that type of accountability. Seto expressed my outrage and hope eventually will get people in your i agencies who do the jb to protect the American People instead of in protecting their bureaucracies. Now chairman, before i close i want to address a serious issue. Ofthe last time we were here the is a coordinated assault pretending somehow republicans were at fault for their not being additional money for the pandemic. Lets revisit some of the facts if we can do. On a bipartisan basis actually passed extra funding for covid, 15. 6 billion in march and the optimist for testing, treatment vaccine global aid. But the speaker of the house either couldnt pass that legislation or did not think pandemic money was a priority so she stripped it out. I have worked with her for a long time im pretty sure shes a democrat. Then senator romney and blunt and myself engaged in deep negotiations with majority leader in the chair of thehe committee. We reached a deal for 10 million in domestic funding for covid. But the majority leader did not to take a vote against lifting a covid restriction on the southern border. Probably because he knew it would pass so the deal wasvi killed. Pa each of you got together republicans are at fault. Republicans tried twice to provide additional funding foror covid. Democrats could not take yes for an answer. Then last month dramatically raise taxes by hundreds of billionsth of dollars. Provided funding for 87000 irsan agents. To audit the middle class andnd spent hundreds of billions of dollars complained about no covid spending did not spend a dime of those new taxes on pandemic expenses. I often hear my colleagues say your budget shows your priorities. Democrats have the power to spend money on pandemic and they chose not too. I guess making energy more. Expensive was more important. I know all the how i had in my jacket pocket a card with four simple request from this administration. I told them all they needed to do for me too get my senate colleagues, my republican colleagues to support additional funding was to provide answers to those four things we gives a detailed plan for covid. Detailed accounting to where the money has been spent. Offsets to match new spending u for pandemics. Simple vote on a covid restriction at the border. I first started that in april. Today none of those four things have been presented. So to date the admits ration is failed to deliver, maybe they dont want to have transparency on what they spent. Maybe they do not want to come clean to the American People with their plan is to come to the election part not sure what it is fair and tired being theo one thats blamed. I got just as much invested as anyone on this committee and making sure your agencies are successful for the American People. I will continue to do that whether i am in congress or not. I cannot thank you enough for your years of service. Its incredibly beneficial to the American People in the healthcare of this country. I hate to see a go for it by look forward to that date in january where we both are on the other side of this mountain. I can actually not have to plan to fly on on monday and i can spend some time with my wife and grandchildren. Having said that, madame chairman lets have a reset this morning print lets quit blaming everybody. Lets start showing somevi leadership. The Administration Needs money and send us a budget that requests money. There is no increase spending forle covid. Rick people not be held accountable. Thats wrong forget the ministration to requestha the money but lets work the normal appropriations process. My hope is there is a player and someday they will share it with us. I yield back. Thank you. I will doctor michelle wolinsky as a Director Center for Disease Control prevention and the administrator of the agency for toxic substances and diseaseth registry. Dr. Anthony fauci of allergy anu Infectious Diseases and the chief medical advisor on president bidens covid19 response team. Doctor robert is the commission of the food and drug administration, don oconnell as assistant secretary for preparedness and response. Director wilensky, director fauci, an assistant thank you all for being here today. We all look forward to your testimony paired with that we will begin. Members of the committee, i appreciate the opportunity to discuss a monkeypox and cdcs response to this horrible outbreak. Urto date there been over 59000 cases of monkeypox reported globally including over 22000 cases and one confirm death. In the current outbreak for current cases were diagnosed with the United Kingdom on may 14. Within days additional countries began different case clusters. I made 17, cases reported in massachusetts and confirmed by cdc. Cdc immediately began its work but searching for additional cases, educating clinicians on the public about this disease and Public Health partners andch their response. And less than one week cdc over the last several weeks weve been pleased to see a decline in the growth both here and abroad for their art areas in the United States with the rate of rise in new b cases is still increasing. We approach this news with cautious optimism. Too aggressively respond to oura entire toolkit including vaccinationmi, testing and education about risk to form behavior change. This outbreak has been notable for transmit mission primarily but not exclusively through sexual contact. It is disproportionally affected gay, bisexual and other men to have with men. With a large majority of cases in this population. Cdc has been setting a monkeypox for decades. And has contributed to the creation of the test experimental therapeutics, and vaccines that are available today. As a relatively rare disease no parades in the u. S. Have seen or heard of monkeypox. Education has been a key component eat a remarkable challenge. But critical to our response. For health advisors, each reaching over 1 Million People and host clinician outreach calls with shared monkeypox information for congregant living in k12 schools to prevent monkeypox spread in these settings. Initially our Public Health Laboratory Responsex a Network Across the country were able to collectively test up to 6000 clinical specimens each week. Using a diagnostic test developed to detect monkeypox bread cdc it worked to quickly expand Testing Capacity but engage commercial laboratories keto increase capacity to 80000l tests per week. But werc click testing volume ie currently 14 of total Testing Capacity, we are one with academic medical centers, commercial to make testing even more accessible to all who need it paid from the beginning of response, cdc has worked closely to make a vaccine available and underlying at increased risk based on data from third eye jurisdictions reporting to cdc have been administered collaboration or communitys most affected by the outbreak including Lgbtq Community is critical to our response. We rely on our partners across Public Health and lgbtq advocates and Community Based organizations to contribute to the expertise to our response. To challenge us to do better. And to amplify our Public Health messages. In recent weeks cdc has provided Technical Assistance and support for Vaccination Efforts and other monkeypox response activities at large events serving lgbtq class audiences, like charlotte pride and a gay pride weekend. Last week and others have delivery vaccines to those who may facear unique barriers to access including racial, ethnic and geographically diverse populations. The robust response required for Public Health threats like a monkeypox underscores the importance of sustained that should constitute the foundation Public Health system. In addition, cdc needs additional policy levers to enable the timely reporting of emdata necessary to take the informed action, the public expects of us. Despite having a Vaccine Distribution strategy since juny september to complete all 61 data use agreements needed to receive Vaccine Administration data. While we work to control this outbreak in the United States w anticipate monkeypox will continue to be a global threat. Once this outbreak is controlled we will need to maintain vigilance, education and Vaccination Efforts so that another outbreak does not emerge. That is why and now it is important for congress to act upon the supplemental request. Cdc will use the Additional Resources to support testing on Laboratory Capacity expansion. Surveillance, epidemiological investigation, outreach, education, and globall efforts. Together we can meet the fast evolving threat of monkeypox current outbreak and prepared for any future outbreaks. Thank you, i look forward to your question. Thank you. Dr. Fauci. Madam chair, Ranking Member burke, members of the committee. Thank you for me the opportunity to discuss the role of the National Institute of allergy and Infectious Diseases and conducting research to address the ongoing monkeypox of Public Health emergency. I will outline of how prepared for, responsive to the emergencu of monkeypox virus. Nefirst, want to provide Historical Context that relates to past, current, and future research efforts. The epidemiological pattern of monkeypox cases and bears a striking resemblance to the early cases of hivaids. In the United States and other stnon endemic countries monkeyx is disproportionally affecting men who have with men. A however, scintillating virus include monkeypox, regardless of their age, gender, identity or sexual orientation. Thus, we would be wise to heed an observation i made 40 million years ago an article i published in 1982. During the first year of the hivaids pandemic. When i referred to old we would soon call aids eye disease that did not even have a name at that time. And i quote from that publication, and the assumption that will remain restricted to the segment of our society is truly an assumption without a scientific basis unquote. Although we must focus our efforts on the group that is most predominantly afflicted and at risk, learn about this disease. Serve surveys, ongoing surveillance for new cases are criticalep importance. In addition, much work needs to be done in virology, immunology, transmission, animal reservoirs whose well as a diagnostic therapeutics vaccine which i will address in a moment. Our early years of aids in her Current Situation with monkeypox. Unlike the situation, at the start of the aids outbreak, agent of monkeypox has been known for decades. Medical countermeasures have been developed. Namely vaccine and antiviral. This is the result of decades of research on monkeypox virus and other viruses including the virus that causes smallpox. Supported research was essential to the development of vaccines. We funded a number of studies from the preclinical stage through phase two Clinical Trials to evaluate safety, duration and then transition the vaccine which supported advanced clinical evaluation and we recently launched a Clinical Trial further evaluating alternative routes of administration. In the area of therapeutics defunded the discovery. And the preclinical studies to determine the mechanism of action and its safety and efficacy in animals. Again we also funded phase one and phase two Clinical Trials. Clinical trials to evaluate this drug in humans with monkeypox are needed to gather Additional Data about the safety and efficacy of the drug investors have recently launched a phase three Clinical Trial focused on outpatient setting in the United States the aids Clinical Trial group. A separate study in collaboration with researchers in the democratic republic of the congo will begin eminently. It is worth noting the study in the drc was planned prior to the current global outbreak as part of our preparative to study high consequence pathogens in Key International locations where they are endemic. Lessons learned during response to aids in covid19 such as avoiding stigma and ensuring the medical countermeasures get to where they are needed most. Ongoing monkeypox activity. In addition the u. S. Response to monkeypox help to inform poreemerging infectious diseasef potential. Thank you for your attention ill be happy to answer questions following the presentation of our colleagues but. Poiathank you. A turn on your micro. There you go. Gerry murray, Ranking Member, members of the committee. Thank you for the opportunity to provide information on fdas ongoing work related to the monkeypox virus health emergency. Fda has been actively working with our government response the continuing Public Health threat since the first of monkeypox case came to the u. S. We have been working diligently to help ensure access and proper information regarding vaccines, diagnostics and treatments that need them most. There is currently one fda licensed vaccine available for the prevention of monkeypox. Or we originally approve this modified vaccine for the prevention of smallpox. Violent reports of monkeypox in may, fda recognized production for this vaccine would need to be accelerated. Fda Work Together to expedite the submission of a manufacturing supplement that would allow more doses to be used in the unitedin states. Fda approved that supplement in july. Following an inspection of the manufacturing facility in europe. In august we granted emergency use a authorization for Intradermal Administration of the vaccine. Which is helped increase the a supply of vaccine available to americans. The authorization out additional review of the 2015 Clinical Study that evaluated to dose a series given intradermally versus subcutaneously individuals 18 years or older. Extensive experience with a vaccine in germany data indicated intradermal W Administration produced a response modestly different reaction profile the combination of vaccination preventative measures to reduce for contact with the virus remains the best way to breadth the spread of monkeypox a vaccine is available to Intradermal Administration, for individuals 18 years of agei and older. Determined to be at high risk for mug epoxy and viable subcutaneous for those under the age of 18 to be at high risk. Its important to recognize we do not have Clinical Data on safetyin and efficacy fda continues to monitor the safety date we are receiving following jenny is nationwide. Nh initiated trial to obtain further data. Fda also were close of cdc manufacturers and laboratories to support diagnostic test development. Undetected or the box of viruses including monkeypox. This test is to available through 67 cdc Laboratory Response as well as a five for large. On september 7, following an Emergency Declaration from hhs, fda issues eua for an additional test. We also issued guidance on the diagnostic test and opal increase diversity and availability of tester monkeypox. Currently there are no fda approved treatments for monkeypox. Fda approved treatment for smallpox currently made available to monkeypox patients under ac dc expanded access investigation drug protocol. Approved for smallpox using animal role person approval pathway meets only when human trials are not feasible. But because of monkeypox remains endemic in countries around the world of a large outbreak in the u. S. , human Clinical Trials areo both ethical and feasible. In the way they were not feasible for smallpox which eradicated anden is 30 50 mortality rate. Without human trials we do not know if its been beneficialas r patients with monkeypox. Rt drugs that show efficacy in animals are not always effective in humans. The four Clinical Trials, one of which is now underway as dr. Fauci has mentioned to the niht will be necessary for fda to determine if its safe and effective to treat monkeypox. In the meantime because there is a significant risk judicious use and proof of monitoring the development are paramount importance. For stewardshipe of this beneficial drug always studying Clinical Trials. Fdas dedicated staff work to ensure a a robust response to te monkeypox outbreak bread thank you for the opportunity to testify today tor look forwardo answer your questions. Thank you. Secretary oconnell. A chair murray, Ranking Member burr and distinguished members of the committee. Its an honor to testify before you today on work and ongoing monkeypox. Let me start by sharing the work aspers done to procure and distribute vaccines for the strategic National Stockpile stores vaccines that can be used in the smallpox outbreak. Among the vaccines it stores as a small stockpile of jenny osa relatively new vaccine for thosc who are immune compromised and unable to tolerate the life replicating virus. W since its also license for monkeypox when they first case of monkeypox in the u. S. Was identified the sns had 2400 miles and its on hand inventory. Immediately deployed vaccine. There were still only two known cases in the u. S. , asper requested 36000 vaccine vials b shipped from our u. S. A government owned reserve, stored. There were only 13 known cases it order additional 36000 files from its reserve. And when theyre only 35 known cases, ordered additional 300,000 vials from its reserve it. All this was done to stay ahead of the virus. Case counts were very low in the United States, we were watching the quick spread of cases in europe. It was about two or three weeksf ahead of us. Remove. Quickly anticipating similar spread in the weeks to come. So far has made over 1. 1 million vials available to states and jurisdictions for use against the current outbreak. We have purchased 5. 5 million more to arrive over the next months. Bringing manufacturing capability on shore has been another focus of mine. With currently purchases second 2. 5 million doses to be filled and finished our contract required those doses be filled and finished in the u. S. We have been pleased to support the arrangement to do that in michigan per would provide a grim with 11 million to sigurd the equipment and staff and is to ramp up quickly prior visited graham two weeks ago is there bringing on this newsline. Was pleased with thehe progressi saw and to hear it they will be adding over 70 new jobs in michigan to support this work. Vaccines are not the only medical Counter Measures are made in this outbreak. But 7 million to date courses have been distributed. Ive been pleased to make both his medical Counter Measures it is the right thing to do prep not lost sight of the fact both were developed in stockpile for use in smallpox outbreak. I have consulted with the interagency body responsible for advising hhs on medical Counter Measures. They have agreed with the approach we take in. As we move forward with our response we consider ways to make our small kick top case ability. Who work and monkeypox we digitize we opted to use ase program to therapeutics in the system rather than using separate non operable systems for each as theyve had to do and the covid 19 response. Is the multiplatform ordering system modernizing the infrastructure for the current response and for future responses. Weve also expanded the number of sites which the sns delivers. At the start of the outbreak only delivered a five sites in each jurisdiction misses more than enough the high consequence of largescale events the s and s has been deployed to such as hurricanes and tornadoes. However after some advantage of multiple Distribution Sites and covid 19 very vaccine and therapeutic effort the sns contracted for similar Distribution Network for its countermeasures. This is just two of the examples of the lessons we have taken from the ongoinge covid 19 response and applied to the current monkeypox response. Responses cannot be static. And it regularly account for nei information and evolving scientific understanding. This is been true of the monkeypox response thus far. And it will be as it continues. Thank you again for inviting me you on the with support the ongoing monkeypox response. I look forward to answering your questions by. Thank you for our witnesses for your testimony and being here today will now begin around a five minute questions with our witnesses but as my colleagues to keep track of your time. As always hopefully can stay within those five minutes. I know each of your agencies have worked relentlessly to respond first to covid and now monkeypox. I would say frankly, too many missteps were made early on in the response. Couple hundred cases turn into 21000. It is unacceptable to communities who already experience barriers to accessing healthcare like the lgbtq in the black and latino that are hardest hit by this outbreak. Access to testing wasnt elite talent in the monkeypox response with many people reporting significant delays in t both accessing the test and learning the results. To continue to have these challenges around testing is just simply unacceptable. So doctor let me start with you. How is the cdc working to make sure tests are more accessible and results are available earlier . Thank you center for that question. One of the big challenges we have in terms of access to testing wasnt both patients understanding theirt presenting with the new infection. And providers b understanding tt this was a new infection they had to test for. Indeed, another important clinical consideration was people were coming and requesting a test with had no symptoms and they had no rash. As the doctor notedde the test r this infection is a swab of the rash. In fact there is no other fda approved test. We need to have a rash in order to conduct this test but muchtef what we have done and i should mention weve always had more capacity than test coming on reusing 14 20 of our capacity buried to address the access issues we had to work with clinicians. We have to work withda patients. The providers would understand how the test note not to date keep those tests. That was the work we did early on as were scaling up testing know we may need more testing coming forwardly through the lab to Response Network we increase our capacity to test. You expand the manual extraction to automated transaction reworked or commercial labs to expand testing across the country simultaneously working with outreach and education to providers, clinicians, patients in Public Health, thank you very. Thank you. Secretary recently declared the fda can use the emergency use authorization pathway for monkeypox test but how will that improve the availability of new detest . And what steps are you taking to improve on the progress that youve made . The first of all, let meog concur with dr. Walensky. Theres never been a shortage of test is a shortage of test. The authority has enabled us for five commercial labs which are offering the test at this point. We issued guidance individuall institution developing Laboratory Tests should proceed ahead. We have given people clear guidance and templates for developing their test and figuring out if theylo work. So on all fronts the gates are open under a watchful eye. We also must keep in mind one of the lessons from covid was that when the gates are open a lot of test turned out to be not so good got out there. We had to rein them back in. I am encouraged by the declining cases. It really is imperative we remain vigilant. Despite efforts byd hhs to increase access to vaccines, some people in my home state of washington still go to Great Lengths to get one. Including crossing the border into canada. Now, people understandably want to be vaccinated before they get exposedud. But that means we need more vaccines. Some serious stumbles were made this year when it came to our vaccine supply. What have you done to make sure that never happens again. Increase vaccines right now . Chair murray thanks so muche that question for whats most important to those who need access get it. You continue to do constituents please let us know where in the business right now of knocking down those hurdles and making sure the vaccine can be accessed. We did it take a very small stockpile that was intended for smallpox was eventually to beat freeze dried smallpox and converted to this active monkeypox response. That required a couple oftu challenging problems to solve. We moved the first 372,000 miles as i mentioned in my Opening Statement, immediately. We needed fda to approve and their terrific partners moving quickly to approve that second manufacturing wide that drew the 800,000 vials we were waiting for. Worked quickly additional 5. 5 million vials of the bulk drug substance g are intended fr smallpox. We have ordered that to be filled and finished and shipped to the United States. 2. 5 will be manufactured by adding a second line and grandmi won his onshore domestic manufacturing will be able to access these vaccines much quicker in the future. It is a critical step forward in our preparedness both for the monkeypox response in future smallpox programs record senator burr. Thank you chair. Tony, lesson we spoke on monkeypox here you made it very clear monkeypox result of animal to human transmission. And that happened abroad. Here is my question. What are the chances and hasnt been studied whether there can be a transmission from human to animal in the United States where we could have a threat that iset animal to human transmission that is domestic . It is certainly possible senator burr. Whenever you have a situation where you have an animal reservoir and the virus is already shown you from the standpoint of transmission it can infectat animal species they actually have an individual who isow infected, there is no real reason why that could go the other way. I dont believe we have seen that. But i would not be surprised if we do see essentially going back and forth that is possible for. I would present a real problem. That would present a problem of the propagation. There is a eradication for is illumination and there is control. The best way to eliminate is to be keep it out of the realm ofl. An animal reservoir which continues to re feed into the human population brickwork great thank you. Don, news outlets recently reported the administrationsin evaluate whether some doses should be held back in the stockpile to meet requirements for smallpox rather than distributed to support the current monkeypox response. This seems to conflict with fdaa recent decision to implement dose bearing strategies. Maximize the number of available doses. Can you score this up for me . Thank you Ranking Member for that question. So we continue to maintain our smallpox preparedness that is critical. Our frontline vaccines continu to be available and have not been impacted by her monkeypox response. We have added the capability to be able to provide the vaccine to those who are immunocompromised in the case of a smallpoxou outbreak. And we are evaluating with each dose to make available to the monkeypox outbreak what it means for that preparedness and smallpox. Ive met and consulted with them to understand whether we need a separate monkeypox stockpile so we can pull this vaccines off the shelf and not worry about the preparedness for thera immunocompromised in the smallpox outbreak the. About the messages into the at risk population use suggestco to them though they are in the midst of an infection problem, we are discussing holding back in case we have gay men in the United States, we have about 1. 9 hiv aids positive gay men thats a population 1. 9 million sexually transmitted a monkeypox of 13 or 15 million. Somehow we are cheering the fact he put out 700,000 vaccines. On top of that when to cut the amount youre questioning whether you are doing everything to help them. That may be a reason weve only afforded 61000 people vaccinated out of a pool a defined a pool of up to 15 Million People of which 1. 9 million are immunocompromised. Because they are hiv positive. Dr. Kagan currently the fda. And switching gears are quite currently the fda authorized covid19 vaccine and antiviral treatment through purchase only by the federal government. Providing anyone else its not government for purchasing these vaccines. I believe we all agree on the crucial role vaccines and treatments play in stopping reducing the spread of the virus. So, why itt must every dose of pass through the bureaucracy of washington before it reaches a patient . And why are wey still restrictig access like that . Like that . Thank you senator burr. I, the way im glad youre fully functional after recent surgery. Youre showing good evidence of that. Let me just say that we have the vaccine, its available, anywhere you can just make your appointment and get it. There thats what i plan. One last question for doctor fauci if i can. The pediatric immunizationn schedule recommends four doses of polio vaccine before one reaches the age of 6yearsold with new cases in new york state. Im wondering to do we know how long immunity for the vaccine lasts and to what extent is someone protected if they were completely polio vaccinated as a child . It isnt necessarily lifelong, but it is measured in decades and decades so if a person has the full series of vaccinations, you could expect that they would be fully protected, situation thatf they were concerned about of those that either had no vaccinations like we saw to Rockland County and new york or individuals that have not completed their full course. But ifck you have a full course, however since it doesnt necessarily lifelong when a person goes into a zone where there is a lot of polio, you would recommend they get a boost but i wouldli refer to perhaps doctor wilensky has something further to add to that. I would think the chair. I want to start by thanking the witnesses and obviously thank you for their Public Service. I will start with part of the success of the covid19 Vaccination Campaign was the gradual shift from large vaccination sitess to hyper locl sites where people could find vaccines in their own neighborhoods. For example like local pharmacies. Weve seen the way this can help with uptake, whether we are talking about the vaccinese for the treatment, new threat i should say or for routine vaccines like influenza and childhood vaccines. People know and trust their own doctor and providers and respond to communitybased and Community Member led efforts that lead them where they are so how are you working with state and local partners to make sure we reach everyone at risk for affection to make sure they have the opportunity to get vaccinated if they choose . Thank you, senator. We were doing it in the places we were seeking care. Many of those places where Sexual Health clinics or state run clinics. Its a very important that we do this in a nonstigmatizing and affirming manners so we were doing it in places initially people were seeking care but then many of the Lessons Learned as we learn more about the vaccines delivered over half a million to members of the community is that we need to do more outreach. We need communitybased organizations. Im pleased to say over the last few weeks we sponsored vaccine activities in several largescale Distribution Sitesor like atlanta pride, charlotte pride, boise pride and southern decadence. When weve done so weve had successful campaigns, so we vaccinated over 4200 people. Cesimilarly with the 3,000 peop. What we need to do now is to those in smaller scale and so rather than these big events we need to meet people where they are with s communitybased organizations exactly as you say. Thank you. Next question for both you and the assistant secretary oconnell. We know that in the aftermath of the pandemic and now the emergence of monkeypox as a thPublic Health threat the need for ongoing investments that chair mary has called for the Public Health infrastructure savingnt lives and our state and local Health Departments have been struggling for years after two and a half years of the pandemic and now monkeypox in addition to that they simply dont have the resources for routine Public Health work. They have to move funds around and sacrifice the programming like the ongoing opioid epidemic, tobacco efforts, cancer screenings, routine vaccinations on and on. So how would additional sustained funding for Public Health infrastructure help us be better prepared for new threats like a new viral outbreak and i will start with you, assistant secretary oconnell . We see states and jurisdictions and Public Health departments worn out, tired and exhausted we know theyve been working for two and a half years aroundtheclock and weve been relying on them for therapeutics both in the covid19 outbreak as well as this new monkeypox outbreak. One of the critical investments wouldd be an additional staffing and not just throwing supplemental funds out that higher people but dont sustain them. Itss important that we have multiyear funding that supports our Public Health departments. Its also critical that we can build h the systems. I talked about the system we put in place for the digitized ordering which is interoperable thaty we are no longer having them trained on something the cdc sets up but we have it on one system they talk to each other they can order their vaccines and therapeutics. By introducing that we knew the states retired and we worked very carefully with them making sure they understood why we made the decision and how it does push us forward in a supportive way as we face the current outbreak and future ones. I know you might want to say more. If i can briefly add the Public Health infrastructure is key and there needs to be disease agnostic and long term sustainable rather than the crisis to complacency and i will give you an example the Public Health partners in the jurisdictions do not have a line item for the monkeypox resources. Theyve had to respond trying to oube flexible with other resours that are not legally allowed, so as you know, the key Public Health infrastructure of workforce, Laboratory Infrastructure so we can scale up swiftly and then data infrastructure. Thank you. Thank you very much. Senator paul. If she got the flu for 14 days she has as protected as anybody can be because the best vaccination is to get infected yourself and if she really has the flu she definitely doesntt need a flu vaccine. She shouldnt get it again. She doesnt need it because its the most potent vaccination is getting infected yourself. This is an ongoing question and weve had evolving opinions from you, doctor fauci. Currently, antibody surveys show 80 of children, approximately 80 of children have had covid and yet there are no guidelines coming from you or anybody in the government to take into account they are actually acquired immunity. You see quite a certain if you resolve in 2004. In 2022 theres a lot less certainty. One of the things we also know after looking at this for two to three years is that the mortality is very similar if not less than in the last. When we look at this we wonder why you seem to really embrace basic immunology back in 2004, how or why you seem to reject it now. I dont reject basic immunology and ive never denied that there is an importance of the protection following infection. However, as we have said many times and as has been validated by the authorization by the fda through their committee and a recommendation by the cdc to the ofcommittee that a vaccination following infection gives an added extra boost. The video you showed is taken out of context. I believe that is when someone called in who had a reaction to a vaccine and asked me by telephone in the interview if they should get vaccinated again so in the context of someone wh had a reaction. As a matter of fact, reuters fact checked that and said the 2004 comments do not contradict his pandemic if you look at the words behind, she doesnt need it because the most potent vaccinationif is getting infectd yourself. It is true, senator. It is aa very potent way to protect. But youre trying to tell us kids need a third or fourth vaccine are you including the variability or the variable of previous infections in the studies, no you are not because you have approved vaccines in recent times and the committees dont report anything on hospitalization or death or transmission. They only report that if youve given a job they will make antibodies and you can give kids hundreds and will make antibodies anytime but that doesnt prove efficacy. So what youre doing is denying the very fundamental premise of immunology that previous infections provide some sort of immunity. Its not in any of your studies. Almost none of your studies from the cdc or the government have the variable left whether or not youve been previously infected so lets look at adults. Three infections. Shouldld i get a fourth one if theres a category that has a fourth one and you need one that has nothing, no vaccine or the fourth vaccine but you also need to know whether it infected if you ignore whether theyve been infected, you are ignoring the vaccine basically, ignoring a variable so what you are giving us, you decry the vaccine hesitancy. Youre not paying attention to the science. The very basic science that previous infections provide the level of immunity. If you ignore that in your studies and dont present that in the kennedys, you are not being truthful or honest. I have never, ever denied infundamental immunology. In fact i wrote the chapter in the text book on medicine of immunology. Any of the guidelines, do any of the guidelines for vaccines for the government include previous infections as something to base your Decision Making on . Do any of the guidelines and full of previous infection . Thats why youre ignoring previous infection because it doesnt involve the guidelines and furthermore, weve been asking you and you refuse to answer whether anybody on the vaccine committees gets royalties from the pharmaceutical companies. I asked last time and the response was we dont have to tell you. Weve demanded through the information act and youve said we are not going to tell you about when we get chargedt we are going to change the rules and you will have two days old where you get your royalties phenomena and if anybody in the committee has a conflict of interest, we are going to learn about it i promise you that. Can i respond to that, please . There are two aspects. You keep saying you approve and you do this or you do that. The committees that give the approval are fda through their Advisory Committee. The committees that recommend our cdc through their Advisory Committee. And you keep saying im the one thats approving a vaccine based on certain data weve got to move on. Could i please answer that. You keep asking committees. They are not my committees. They are for the fda and the ac ip. So i dont have any idea what goes on. We are going to move on. Everyone is over i just want to make sure we keep on time. For the record i know chair murray and of both parties have found videos to be out of order and i will note for the record the videos out of order. Bo we will move to senator smith. Thank you, mr. Chair. I ask unanimous consent to submit a letter from aids united, the aidsr institute, te National Alliance of state and territorial doctors, the National Coalition and its a National Minority aids council outlining recommendations for the comprehensive approach to the response. Could i have unanimous consent for that, please. Thank you to the witnesses, and i i want to add my gratitude for your service to the country during some of the most challenging times. Tri want to start by associating myself withtr the remarks about the importance of congress coming together to make sure the administration has the resources that itci needs to respond to te Public Health emergency and i also agree on the need to sharpen the response with Public Health departments including in minnesota. Assistant secretary, we had a good discussion last week about the distribution of the vaccine and i want to follow up on that. We talked about some of the challenges of the department. The issue is after they opted to use the system as i understand to distribute vaccines rather than the trump system which is how Covid Vaccines were distributed and what the department is used to. Asas i can understand it the system works better for distributing both Monkeypox Vaccines and treatments directly from the strategic National Stockpile. There are also challenges with interoperability as i understand it with vb trump system. But of course the issue as we discussed is that by using two different systems, one for covid and one for Monkeypox Vaccines, this is a challenge for the department of health and i suspect this is a challenge for others. Of course it is happening at a time the challenges are falling on the Health Departments and staff that are exhausted and burned out after the last years of responding and learning a new system in the midst of this is a challenge and exacerbated by tracking shipments. Sometimes monkeypox does is show up unexpectedly. Can you just address for me, and i appreciate you talked about this and the testimony, can you address what steps you are taking to work with state Health Departments in similar situations to minnesota, to help improve how the Distribution Process is working . Thank you and thank you forar the good conversation we had lastst week. And an opportunity to talk about some of the challenges. Most important to us those that need vaccines can get them so if anyone continues to find this to be a difficult system, please let me know we want to knock down the hurdles to end sure folks have access and we now have enough Vaccine Supplies so its important thatt people are able to access it. We have a similar challenge mentioned with the states. The states arent able to use their funding for the response. We havent been able to use our funding for the response either so whense it came to digitizing the process, we were going to have to put more money into the system. At the age pop system is to order therapeutics so states do have familiarity. It was used for the vaccines. We were faced with putting the budget into one of the systems to digitize the ordering. We dose acknowledge that our Public Health Department Colleagues are worn out and tired and we have had countless office hours to make sure they understand the system if they are running into any problems we are available to answer them and as hard as the change management is, its the right thing to do to move forward to the interoperable system. We couldnt just piggyback on the Distribution Network that was funded with covid dollars. We had to go with the sns and do a new contract with a different distributor with annual funds and set that up so thats one of the reasons there was a delay. We needed to overcome this and look forward to making response dollars more fungible in the future i will submit a question for theth record about the importance of tribal consultation to the witnesses and look forward to your response. Senator collins. Thank you, mr. Chair man. A secretary, i want to follow up on the statement that you just made. Iyo dont recall. Its not at all clear to me that you couldnt submit a programming request to the Senate Appropriations and House Appropriations committees. How are you implying what you say that you havent beenns able to transfer youve taken funds for other purposes including sending it toos the border. Weve been advised by the Legal Counsel and Appropriations Team our budget and finance team the money thats currently in the contract which is the Distribution Network that we couldnt piggyback on the samer contract to set up a monkeypox Distribution Network. We took additional funds and set up a different contract with the sns to set up a Distribution Network. Let me turn to another issue that we discussed several times and i do appreciate the fact that you have made yourself available. We have statements from back in march that lamented the decline of domestic manufacturing for covid tests and at the the suppl request talks about the volatility that makes it difficult to preserve manufacturing domestic manufacturing. The United States government put a lot of effort and resources into building up domestic manufacturing. What we are seeing day by day and week by week is that of thats beginning to go away. I would suggest that its the administrations contracting policies that have weakened the manufacturing of covid tests. As you and i have discussed before, the majority of the athome test the administration purchased were manufactured out of sight of the United States. For example, the administration awarded a chinese company, a 1. 3 billion contract thats roughly four times the size of the contract that was awarded to an American Company with considerable presence in my estate. How is it that the administration is working with the manufacturing when at the same time youre awarding contractss to the Chinese Companies . That doesnt help to preserve domestic manufacturing. Domestic manufacturing is a Critical Mission of hours eking sure its supported and and and during part of the response when it moves to the steady state we willis always want to know. Testing is critical and manufacturing ofe tests is also critical and regarding the contract you will recall when the president made the announcement he was going to make 1 billion tests available through the Postal Service Distribution System covid a test. Gov he also vowed at the time he would not interrupt the commercial market and wouldnt take tests that are going to the pharmacies and other stores. He wouldnt take them out of the market and put them into the program. In order not to disrupt that at the time we pulled in internationally so as not to interfere with whats available at the pharmacies. As soon as possible leveled out we made a commitment in the spring to only support domestic tests moving forward but that decision was to not interrupt the domestic tests we were currently feeding the schools and pharmacies stand other pieces of the response. A veryry quick question for you the monkeypox cases are related to the sexual transmission and men who have sex with other men. Doing more to look at Community Spread and cases in there were o Broad Community suh as for example testing anyone with and atypical case of herps or shingles regardless of their sexual history. Thank you for the question, senator. The answer is yes we are doing surveys and surveillance that go beyond the well established high level of affection and demographics groups and that is part of the five pillars that i mentioned in my statement about biology, immunology, transmission and a zero surveillance. We are doing that inou some of e studies but the cdc is also doing that and we are also doing it in collaboration with of them using some of our cohorts in collaboration with of the cdcs capability to do that. Perhaps you want to comment. Thank you mr. Chair. From the fact check of the 2004 comments do not contradict the pandemic stance. I want to join my colleagues and wishing you a very well in your retirement and thank you so much for your service to the country. With sustained investments and preparedness that is why i lead of the disease act to provide the Countermeasure Development for viral families noted concern we cant just keep responding to the threat in front of us. Can you explain how investments in Smallpox Research has made us better prepared for this outbreak van had we not made those investments . Thank you for that question because it relates not only to the extrapolation but virtually all elements of the basic fundamental research that when you get to a problem that is a Public Health problem to be applied. As i mentioned in my written and oral statement, the original work that had been done on the viruses dating back to 2001 and 2002 following the anthrax attacks when we put a lot of work into developing the countermeasures that the assistant secretary mentioned regarding smallpox allowed us by getting another type of vaccine that is less reactive and has less adverse events that led to the primary vaccine for monkeypox so the relationship between the Smallpox Research that has been done for decades and the acceleration of that research when we had the threat in 2001 and 2002 allowed us to respond rapidly with already developing countermeasures. As we had a chance to speak earlier, monkeypox is too reminiscent of our initial response to hivaids. I actually started my career in 1986 on the county board of supervisors. In that year the first cases of hivaids were reported in wisconsin. There was a tremendous amount of fear and paranoia and sorrow in our community. We had to fight both the disease and the fear and the stigma and discrimination that was present. Can you describe the cdc efforts to work with the lgbtq plus community to combat misinformation and reduce stigma and and sure folks have access to care . Thank you for that question. The involvement in the integration has been critical. One of the first things when we heard about the case to come togetherch to make a robust response. Weve had extraordinary outreach with the community and weve met several times at the human rights campaign, the Community Serving the pride organizers and we facilitated best practice exchanges with tourism and fire island this is one of the Lessons Learned from hiv decades ago. What practices would decrease the risk of monkeypox. What are they doing to ensure the delay in Vaccine Availability is not a problem in the future and anything you need from congress to help address this. I will turn the gavel over and at the next to senator, senator cassidy. Thank you, mr. Chair. I was a medical resident in 83 to 86. When it exploded. This has to be predicated on trust between the American People and agencies. Ive asked on multiple occasions. Youve never given a straight answer so i would enter for the record an article in which they did a request to find out how folks at the cdc were actually working, showing up so to speak and roughly 2,772 out of roughly 13,000 employers are showing up every day. About 78 are working completely remotely or come in maybe twice every two months. Now, why is that important . First it was a noble fact but wasnt shared with congress we the representatives of the American People and i think the American People would like to know if the cdc isnt functioning well how many people are actually showing up. I mentioned to cdc isnt for the New York Times and from august 17 in which you frankly to your credit point out the cdc has notwh been working well and there is need for wholesale change. At the end of the article, they quote as the acting director of under president obama who says that its first pointing out your still working remotely at least august 17. Then its hard to see how he could execute wholesale changes when she only sees most of the staff at a difference. I dont know how you motivate and inspire culture change when people are not together. Cdc is requesting millions of dollars for Public Health initiatives and an agency which by your assessment is and functioning well and which only about 22 of the people are itshowing up every day and previous officials are doubtful that you will effect a change because you dont show up every day. And i say that kind of painfully because i want the cdc to work. Theres been a lot of talk about them to have to modernize but cdc was given 200 million in the act for the data modernization to be awarded to 64 different jurisdictions and maybe this is hhs not to cdc above most of it hasnt been spent or allocated. This isma according to the crs. So it is incredibly frustrating that at the deliberate decision was made not to be transparent with the American People. It takes a request from the newspaper and now you are asking for billions more. Why should weop trust . Thank you, senator for the comment. Wefo are in an agency of 13,000 people. The people who need to be of course the laboratory workers. We have many people on the field and theres nobody showing up, the offices are empty so i think that iss another example of beig opaque. Many of them are working at the cdc and then deployed and many of them are on their own. I was in atlanta last week that i was in new mexico with tribal visits and during the Tribal Advisory Committee meeting so many of us are on the road. Let me go back to why should we trust cdc with billions when its very difficult to get i would say a straight answer on what is the workforce in person effort when the agency is working so poorly . To demonstrate the Lessons Learned from the response and the people the cdc are working viwell and working hard and they dont necessarily need to be onsite in atlanta and fact often times they are more productive offsite doing the work of Public Health. We are out of timet but lete just say the former acting director from president obama when he said in the last paragraph of the New York Times article he didnt see, speaking of you in particular, affect change when you only see people every now and then. Is that suggesting it isnt a work completed but something that has to happen now and people not working together made that more difficult to execute and i dont think anybody in here or anybody watching things that only 22 of the cdc employees showed up every dated for the pandemic. Theytc think it was probably 78 and now the number is reversed. Its going to be hard for me to support more appropriations until we havee a better relationship and a more trusting and transparent relationship between the agency and congress which you are asking to fund your activities and with that i will yield. Next, senator hagan luber. Thank you, madam chair and all of you for your service to one of the greatest challenges the country has ever faced. Let me talk a little bit about covid19 and the Lessons Learned. I guess i would ask you, doctor fauci, and i would want to echo also my gratitude and salutations i know you wont really retire because i dont think that you are capable of not contributing to the public good. Pathogen research was critical to the development of the vaccines and treatments obviously a big help with monkeypox but we may not have stockpiled for the next pandemic similar to covid and im asking in terms of the next Public Health emergency how concerned are you that the next Public Health emergency wont be one that we dont have therapeutics for . Thank you for that question, senator. We always are concerned when you get a brandnew infection that you have no experience with thau youre not going to have countermeasures particularly vaccines that are ready in a fashion so there are two approaches to that. Weve described in detaill and several publications and some of our papers whats called the prototype pandemic and prototype pathogen response to look at multiple families and theres about seven or eight high priority families and by families we mean alpha viruses, reno viruses,ty and to do fundamental research for an exae to get commonalities among the pathogens within a family and start to develop vaccines and have them ready to go with the new technology its very simple to switch one in and out of the vaccine. Thats the core of the approach right now and i think you will probably hear more about ite because that is what we are putting forth is the contribution to the governmentwide preparedness as a prototype pathogen approach. And i support that approach. We can agree. In the meantime we have to make sure that we have the funding for the. s. Let me switch to the outbreak of monkeypox for the facility in denmark but the shipment the u. S. Has held up pending there was an fda inspection facility even though the regulators had approved it so i would ask you how can we help the fda better balance the protocols for the urgency end of the need to respond quickly to these emergencies . The issue that occurred in this case had switched had it not been inspected by the fda and i probably dont need to remind you that we had more than one incident in covid times of a manufacturing facility up to par that created a lot of difficulty and trouble after the application came in from the company the time it takes to make sure the vaccine coming out will do the job that is intended and also i would add europe doesnt have a Central Inspection steam for the vaccine facilities. Each country does a ton and weve had some discord historically between findings and some of the facilities and what we found so we really felt we had to get this right even if it took a bit more time. I will yield back to the chair. Thank you, mr. Chair. To my panelists, i read your testimony, listen to your testimony. What you described to me as an academic response to a problem as opposed to being proactive we are beingg reactive and i would challenge you to change your culture. When i look back to the history ofe, this virus july 20th, 2021, november 2021 a case in maryland from nigeria. Others cases in multiple countries linked to nigeria and a moment in time the horse is out of the barn we could have stopped this and its being transmitted from human to animal once it is in the Animal Kingdom t it will never be dealt with to get ahead of this. So, my question for secretary oconnell, would you ever consider a travel ban or requiring vaccinations from people to get back in the country and its and you made a statement of june the third, 2022 that you said i want to say we have enough on hand to manage this current outbreak. Do you still think that was the case then and if so, why is it still exploding . Id like to take the second one first and then invite doctor belinsky. We dont have that much tim, but go ahead. We were using the strategy that has been effective in monkeypox outbreaks including the ones you just mentioned previously. Itus requires vaccines administered to the person that hasin a virus and their close contacts. As a spirit of the outbreak began to indicate partners would make it difficult for Contact Tracing to happen, we pivoted to those that are likely to be exposed and expanded the problem is getting the vaccines to where they were needed. The strategies we were using for the atrisk population changed as we were seeing the transmission change. Just briefly, yes or no did you all consider some type of travel ban requiring people to have a vaccine before they came to this country . We are aware there were no contacts of monkeypox and intermittently including to last year we had the travel cases that have led to no further cases. That happened in 2021. This is a different outbreak. Our first case and when we had our first case i spoke to the inclinician and we called Public Health canada as they traveled from canada and we immediately started outreach with oure colleagues in the uk as well. Theres multiple cases across europe but most of them connect to nigeria. Probably one or two people died with monkeypox in the United States that im aware of, but every day hundreds of americans die from fentanyl poisoning. Why have you not declare this a Public Health emergency or asked of the administration to shut down the border where 90 of this comes from . The declaration is under the secretary so i would have to be for that comment and i will say but you are recommending that to be done. I would say our ability too shutdown the border of the cdc level is related to Communicable Diseases and while the challenge not at all. More americans have died of fentanyl poisoning van and vietnam. Its killing americans every day is fentanyl. Do you not have a heart for these people . I absolutely do. Ive cared for many of them and it is tragic and we are doing a lot of things the authority to shut down the border on anything except Communicable Diseases. We are doing outreach, mental health, community violence, surveillance, we are doing across the border, really quickly in 2017, there been no cases in nigeria for four years. Suddenly there was an outbreak 218 cases since then. The cdc eco health, uc davis funded by usaid were all doing research in nigeria at the time. I think it is for doctor belinsky as well as doctor fauci were you aware of the research and what was the purpose of the research, was it collecting or were we doing more than collecting were we concerned about the outbreaks and i have a list of questions related to that research were you aware of that research in 2017 . I can get that information to you. I will have to check with the staff. . Weve been conducting research in nigeria for years and i would be happy to get the details. Lf do you know the purpose of the research . I would be happy to get that to you. We are conducting a Clinical Trial in the democratic republic of the congo that is into fundamental basic research that is a Clinical Trial in the democratic republic of the congo. I want to thank the chair and Ranking Member for this hearing and all the work. I want to start with a question to give you an opportunity to build on earlier testimony. The department of health and Human Services has been responding now for over two years. Did you address this to some extent in your testimony about could you explain further how the departments experience is anna forming the monkeypox response . Thank you for that opportunity. We are continuing to actively respond to covid19 but continuing to pick up lessons as we go. One ofch the lessons is making sure we have systems when countermeasures are ordered and states can order both the therapies and vaccines on the same interoperable system. Weve done that now as weve digitized the ordering process. It was also important that they have multiple Distribution Sites across jurisdictions and states. Jurisdictions and states got used to that consistent with the consequences that have been responding to like hurricanes, tornadoes entered into a contract for multiple places. 500 ambient, 500 frozen distributions a day for five days a week so up to 5,000 esdistribution points. Another thing weve done is created a framework to ensure that the vaccines arent going to the wrong place. One of the things we saw when we ceded the country in covid and made sure we were giving it out on the basis is that sometimes itg would end up in the wrong place and wasnt being administered so we asked the states to sell the test to 85 tiusage. Is it going to the right places . This hasnt been a barrier. We continue to work to make sure the second courses dont count against the 85 and its been a good framework for us to make sure that they are getting in arms most important things right now and not sitting on shelves. Im going to switch to a different topic, and on the conversations weve had before to discuss another Public Health emergency which is the feelgood crisis. During the confirmation hearing we discussed how the fda helped the crisis by approving and labeling opioids for longterm use. Despite the lack of strong evidence supporting the labels. I was encouraged when you told the committee under your leadership the fda would aggressively look out new labeling. But in the six months into the confirmation the fda continues to ravage communities and all across the country and the agency needs to move swiftly from its previous mistakes. You yourself have repeatedly said the fda needs highquality evidence to support the longterm use of opioids. The agency has the authority to remove labels of drugs now even the absence of the evidence, so why is the process taking so long . . I want to express appreciation for your question and we are currently losing more people from opioids family are from covid, so this is a National Issue that we need to take seriously. Ive taken the First Six Months to get an essay of everything going on in the all of government response and also in the face of the fentanyl mail order issues going on. To get back to the basics of the prescription of opioids we published our framework last week and weve seen changes over the next few months. Parents that have lost two children to fentanyl and opioids. The fda first approved and labeled opioids for longterm use more than 25 years ago. That means theyve been on the market for more than 25 years without substantial evidence that they are effective for that purpose and with plenty of evidence about the harm that these drugs can cause. There is a framework out there but what people are looking for is action and i will continue working with my colleagues on both sides of the oil to make sure itew happens. Thank you for your service. Senator rosen. Thank you, chairman v for holding this important hearing. Thank you for everyone being here doing all that you do in these trying times, thats for sure. I want to talk a little bit of though about clinical guidance for all of our practitioners. Of course theres support staff to prevent and treat monkeypox because i would say manyou clinicians may be the majority have not directly treated monkeypox and havent seen a wide range of cases, so its critical for the guidance to be jowidely available to all medicl professionals, and i would also say theres support staff who do answer the phones, take the questions when they are doing their own histories and physicals. Its important for treatment and prevention. Regarding monkeypox prevention, i am concerned about not just the slow rollout and populations, but i i appreciate youve been doing significant work to make the vaccines more available. But all the vaccines rolling out apthere is the flu vaccine, pneumonia, shingles, of course and other things people might get tested. Theres a lot of confusion about boosters, can i combine vaccines and so im really concerned that the cdc what are you doing for this Public Information campaign on the wide variety of vaccines importance ones. We dont want someone to get the shingles. My parents both had it. Very painful. How are we going to do that with pharmacies and public spaces people may not be going to a doctor or clinic but maybe they are going into their local drugstore or Grocery Store every week. Thank you for that important question and i think one of the things you raised as the challenges that we have seen first with. Covid and now monkeypox and one of the places i would Welcome Congress is how we dont have a mechanism in the country by which we informed the vinew outbreak or disease. So this has been through a lot ofof public education. Weve had a massive amount of outreach and Health Advisory that we reach out to when we put out a Health Advisory and weve done for monkeypox they reach about a million clinicians. Weve done what we call clinician outreach webinars and callswe to reach about 6,000 clinicians and about another 10,000 each one that we do weve done several of those. I personally have sent a lettera to all boarded clinicians through the double amc working with each state to try to send letters out to inform people of the disease they may have never heard of and may have never seen. But tomorrow might walk into their clinics, so what do they need to knowow and what are the protections they need to take and how would they diagnose, treat and care for a patient within this infection, so that s a lot of the work we have had to do during this outbreak. I will say from thefo Health Worker . Safety standpoint as fa as monkeypox weve seen very little outbreak. Weve had one diagnosed Healthcare Worker after a needlestick injury, but weve seen very little Healthcare Worker outbreak due to the personal protective equipment and the outreach that weve done in telling people how to protect. What about the broad idea that we have so many vaccines that are available for the adult population, preventative vaccines than we normally have, flu, shingles, pneumonia, now covid boosters, now potentially monkeypox. How are you going to get this out to patients and consumers in general . Theres the Advisory Committee what if you are not going to a provider, how do you gete it from the average person . We have been doing prep conferences andou advisories as weve rolled out a booster we have a Massive Campaign that we rollout in early october that we will again do this year. One important thing i want to highlight is that we end this country do not have a mechanism like we do with children. In an equitable fashion the way we do for our children. Thats a big constraint we have right now per. Thank you have 20 seconds left. Doctor fauci would ask you quickly, we have monkeypox, the education to treat the infection but their symptom management we hear a lot of facts about opioids but no its very painful, monkeypox. I do not know with the treatment might be. What kind of guidance by giving the medical team unity about effective Pain Management as it relates to the neuropathy i would imagine monkeypox causes . Works there are medications for the neuropathy. But importantly particularly if it is on the surface beat the banal, rectal, or the urethral that can be extraordinarily painful. We recommend, the hospitals do this anyway, i think thats pretty common knowledge, it is in an acute not a chronic pain. The kind of thing you would not hold back on any type of pain medication just because you are concerned about addiction. Ul the discussion that we have been having about fentanyl and the opioids is not using it for chronic pain. This is not chronic pain. This is very acute pain that usually resolves itself within a period of a couple of weeks. You certainly do not want your patient to suffer inordinately by holding back pain medication similar to the pain of shingles in that same way for a thank you my time has expired for thank you very much for. Thank you, senator rosenberg i recognize myself or questions. Is. To have two, one for you ande for doctor fauci. Dr. Walensky, one of the things i panic about is your access to data. Youve talked to this committee about it. I have we have talked personally about it. But outside of emergency authorities you are stuck in a position today which you have to negotiate 50 different data sharing agreements with states over the country. We expect a lot of the cdc. It is hard to expect too much of the cdcs when you dont have the authorities as i understand you need the debtor absent an emergency. But we look at what is happening today with the monkeypox, you are getting data but it is patchy. For instance you are not getting full democratic data. Theres a lot of states that are not reporting to you. For instance breakdowns of caseo on race or ethnicity. That really hurts our ability to target to get the vaccine, who gets resources. So certainly in context monkeypox but maybey mor broadly, what position does that leave you in when you do not have the authorities to be able to compel states in a uniform way to get you good dataquest or. Think its better thank you for your question and your leadership in working with senator kaine, senator baldwin in trying to gets us the authority so we can provide the data to you. We have been working closely, tirelessly state and local staff will be doing the same to extract data on this data. We have negotiated 61 different agreements. Weve navigated your credit to get going for it we set up voluntary arrangements directly with large commercial labs. It has been hard. It should not be that hard thats data coming into us were not making the best decisions for the American People. The existing patchwork is not working but its not looking to the best ability of the American People. For monkeypox specifically i can tell you i do not know the total number of people hospitalized with monthly box. The data on Laboratory Testing complete Demographic Data as you noted. Which people with monkeypox have been vaccinated . We cannot link the vaccine to the Laboratory Data andyo Demographic Data as youve noted we get 27 of the Demographic Datas on testing could we ever see 47 of our Demographic Data on cases and 91 of because of these agreements on vaccination regards i would much rather have you be in the businesss of fighting public threats presented to the country than in constant negotiation. This seems like an essential function of the federal government to set up uniform weight you get data rather than putting an negotiating over, an over, and over again. My hope is that soon we will be able to find a consensus on t tt here. Scary you do not have an people are hospitalized with monkeypox today because of your inability to get that data. In the minute and half remaining out to talk a little bit what we learned what we learned over the course of Intermission Campaign and how that relates to what we are communicating. There has been some amount of information regarding questions about the level of protection. The duration of the immunity when it comes to the Monkeypox Vaccine. I dont know that this was necessarily your fault. And the euphoria of the early news of the Covid Vaccine, we probably got out a little bit ahead of ourselves in terms of what level of production it could provide. What did we learn about how to talk about a vaccine and its early distribution and how does that inform how we should talk about the Monkeypox Vaccine . Click so well, first of all there are two entirely different pathogens. The response in the durability of response to each is really quite different. It was a rather unique situation with Covid Vaccine where there is no doubt that the initial protection against symptomatic disease as well as severe disease was well into the 90s. That was the really good news. The sobering news is the durability of protection. Thparticularly against infection and symptomatic disease. Fortunately the durability about severe disease lasted. But if you look at coronavirus and general which is usually a good parameter of what they response to a vaccine is, even with the coronavirus and affection the durability of protection against reinfection long before covid came along just a typical comment coronavirus as it did not last very long. We see instances of reinfection with the same coronavirus. That poses a very different situation which leads to the need for and the importance of updatingn of vaccines and giving the boosters that are part of the regiment in addition to the primary regiment. When youre dealing with a poxvirus, inherently pox viruses have a i much greater durability of protection. We know that because smallpox themselves, once you get infected you are essentially protected for life against reinfection. Once you get vaccinated with the standard smallpox vaccination, you can be sure the durability is measured at least in decades and may be a what we are dealing with now its at likely is going to have a durability of protection if you get the two doses not Just One Party want to make sure people get two doses. The durability likely is going to bef much greater than the shortened durability of the covid. They are fundamentally two different viruses. Thank you very much dr. Fauci. Thank you, mr. Chairman. First for dr. Walensky and then doctor fattah g. The last two decades hhs has issued only for publict healthsk Emergency Declarations. H1n1, as eco, Opioid Crisis and covid19. On august 2 nationwide Public Health emergency. Of the over 20000 people diagnosed with monkeypox since may of 2022 there has been one fatality. I am concerned the Public Health Emergency Declarations not be taken seriously if it is a litany for every new challenge get the public to buy into it. I guess i would like to ask what are the criteria used for determining whether disease or disorder. Thank you for that question sesenator. What we are seeing in late may early june with the doubling time of about every eight days. Increased number of new cases. And among the things important as we understand when Public Health emergency. In fact i will bite secretary assistant secretary oconnell to chime in here as well but where the about Public Health emergency unlocked for us whether it be inflexibility of funding and resources, whether it be in emergency use authorization. Whether it be and other flexibilities so we have the capacity as an agency to deliver as much help ass possible. I dont know secretary oconnell went to chime in there . Just to concurrent the Public Health emergency created an atmosphere fda was willing to have the merchants that use Authorization Authority it was easier for states senator murphy and dr. Walensky talked about. It makes it easier for local Public Health departments to shuffle employees around in order to put them toward the current response. It created some flexibilities but it was also important signal to the community that we were paying attention. This wasme an emergency in our view we want to provide as much Counter Measures and response as possible. We also align with what who didh Public Health emergency of international concern. We have the most of cases in the world it was consistent what to chime in it quickly we need to keep looking at her emergency capacity and are planning for it. Think we all agree we indicate looking at this as a continuum. With the Climate Change and Everything Else is going to be a lot more of these that come along. Basically agree with that conscientiousness. That being ready for it. You do have to keep in mind that if it does enter some type of sequence where it gets it dismissed because it is being declared too often, but looks like you can develop some criteria that i know its a difficult to get everything into a subset. But i worry about how people will view it. If it is a litany of Public Health crises. When we went to the was the last time we did that out of reuncertainty. Trillions and trillions of dollars along the u way. Dr. Fauci back over a year ago this would the brighton administration including yourself must turn over externa. L communications it happens the. And since july but i dont believe i said theres no contract that i have had over a period of time and would have to eccheck the dates that mark zuckerberg, facebook had contacted me too make some facebookrr live discussions abot encouraging people to get vaccinated. And how we can make sure people can understand the importance of vaccination. It is public record. I think anybody that has access to the public face book with conversations back and forth with him promoting the use of vaccinations as a Public Health intervention. W and i think on that particular publicot health advie about the benefits of the vaccine is probablyte not where its where contention arises. I want to narrow in on this. You use it from the lab or for a wet market. Was there ever a discussion on that . To me thats a different kind of issue. K want to get your question. If the question is do we influence social media in anyan way . The answer is categorically no at that. Any communications that are made in that regard as far as i am concerned art open book and available. The lawsuit that you mentioned i think its missouri and louisiana versus abided and hhs and cdc and fda and the entire government. Because it involves the president is under the department of justice right now. I have handed in my staff have handed over the Department Justices asked for accepted them to make it available. I have held nothing back from anything that i was asked to provide. Ke thank you. About to turn it over. Thank you, senator bert. Thank you, mr. Chairman. Let me conclude if i can pretty want to thank all of you for that work they have done over the last three years. Tony, i wish you wellin the transition. I want to state this and be brief perfectly clear. We do not act or react fast enough. When he said again. We do not act or react fast enough. We have been on monkeypox relist to a real cap recap. May 17 infection in the nine states ten days prior a week, we see this in the uk. Arity big a bulk storage of vaccines sitting in denmark. Bm apparently speeds up there fill finish line those not supposed to go online until sometime in the fall. They apply, fda on june 30 and. It is july 27 before the approval is made. Heres the concerning part. It is april 18 will be signing a deal for domestic fill finish somewhere else. Say that again. We start with mate we know it got domestic infection. We are concerned with our ability to deal withh this. Theres a big. We dont for a fill finish. Not asking for a response. I am just making a point. Type we have a Pandemic Response we have a response plan. I dont know what the limitations have been placed on any of you about sharing this plan whether it was on covid or monkeypox. And i dont really care today. But i do care about is that if you are in the role of leadership in your agency or if somebody in the role of leadership in the future the first thing they ought to be saying is lets sit down as a group and lets put together a plan. Lets know what everybody is going to do. This bs of working independently, the turf wars that exist. We own testing. Beyond this, we on that. When you declare a national emergency, this is no time to protect territory or turf. In every response to us is about ,money. If you need to been changed or reprogrammed, for heaven sakes ask this. Do not use it as an excuse to why you cannot do something. We have reached out many times for the only thing i hear is it data, data, data, money, money, money. Take to heart the doctor said to you. 70 the employees are not comine into the office you do not get much sympathy from us. It may be the wrong time to do a demonstration project about working remotely. The biggest struggle we have got is putting people back in the office. Congress it did it, government is not capable of doing it. Private sector struggling with it. Post covid is veryck different. N but the responsibilities that you have havent changed. Look at the procedures have we learned from the last one im not going to be here again and im not sure patty will hold another hearing between now ande the end of the air. I wanted to know ive looked forward to work with i will continue to be a resource to any of you. I only have one goal and napped for the next i got to respond faster than we did for copen who got to do much better than we did on monkeypox. Because on the other side of this potential is when it gets out of control with massive amounts loss of life. Mr. Chairman i think if your indulgence but i probably missed the boat but thats okay i think this is more important i yield back too. Thank you very much senator. Thanks all the members of the committee for participating. To all of ouri witnesses. Thanks for this really important and thoughtful discussion about the response to the monkeypox outbreak. For any senators who wish to submit additional questions, the record willl be open for ten business days. The Health Committee is pretty generous, ten business stationhe got until september 28 at 5 00 p. M. For additional questions for the record. Without this committee stancee adjourned. [background noises] is. [background noises] him him him. On thursday and update on the response to the monkeypox outbreak from white house officials including nih and doctor anthony algie cdcs doctor Rochelle Walensky bright live at 10 30 a. M. Eastern on cspan now. Our free mobile video app. Cspan is unfiltered view of government putting Charter Communication broadbent is a force for empowerment that is why charter has invested billions building infrastructure, upgrading technology, empowering opportunity and committees big and small. Charter is connecting us. Charter communications cspan as a Public Service along with these other television providers. Giving you a front row seat to democracy. Listened to programs on cspan process cspan radio just got easier. Higher Smart Speaker plate cspan radio listen to washington general daily important congressional hearings other Public Affairs events throughout the day weekdays at 5 00 p. M. And 9 00 p. M. Eastern. What catch washington today for a fastpaced on the stories of the day. Listen to cspan any time tell Smart Speaker plate cspan radio. Cspan powered by cable. Schumer discussed the Inflation Reduction Act and reproductive rights. Mr. President. Yesterday it was truly a tale of two parties