The cdc. Nih director anthony fauci, and fda commissioner doctor robert kayla. Live coverage on cspan three. Good morning. It is unhealthy labor and pitching committee will please come to order. Today we are having a hearing on the federal response to the monkeypox outbreaks as we work to stop the spread of this virus. I will have an Opening Statement followed by senator burr and then we will introduce our witnesses. Before we start i do want to take a moment to congratulate one of our witnesses, dr. Fauci, announcing his upcoming retirement. Dr. Fauci, you have served through multiple decades and president s and Public Health threats. And worked to save countless lives. And i hope you know that you have the thanks of a grateful nation for your Incredible Service to this country. So thank you, thanks for being here today. After the witnesses gave their testimonies, senators will each have five minutes for a round of questions. And what we are not able to have this hearing fully open to the public or media for inperson attendance, my video is Still Available on our Committee Website at health dot 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 for Disease Control and prevention, u. S. Now has over 21,000 confirmed cases of monkeypox, more than anyone else in the world. In my home state of washington has over 500 cases. I have heard from families who are rightly concerned about how bad this has gotten. And Public Health officials including backing Washington State, who are frustrated to see the response run into issues which should be prepared for by now. This is why i have continued to push the Biden Administration about my concerns with the monkeypox response, and urged quick action on testing, treatments, vaccine in clear guidance to the public. To our Health Care Providers and state Public Health officials. It is reassuring to see that we are making progress on the Testing Capacity, which is increase 1000 . And the fda just approved a faster track for additional tests. On vaccines waters hoping to stand up a new vaccine finish site in michigan. A process is working to expand the number of Distribution Sites and states. And the administrations advice for splitting doses has greatly stretched our vaccine supply. And at the administration has started working with states to make Vaccines Available and events with many people from the Lgbtq Community in attendance. And perhaps most importantly, the rate of new cases going down. Now it is all encouraging news news, but let me be clear we must be vigilant in our response. These prominent saying improvements do not discourage issues that we have discussed 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 patience treatments and im constantly talking to Public Health officials in my state have told me how communications with states could have been far clearer and faster and how the challenges and accessing tests and vaccines have delayed the response. I know states have a specially struggled with the federal governments decision to forgo 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 state and even spoiled after storage at the wrong temperature. There are been issues with Vaccine Supplies as well, like when thousands of vaccine doses were delayed because the fda had yet to inspect the new plants that they were coming from. Or when the Biden Administration missed an opportunity to procure more vaccines at a Crucial Point in this outbreak. And again we are seeing inequities worse in this outbreak for some communities. Advocates in the Lgbtq Community to face the vast majority of cases have also made it clear that they feel they are being overlooked or in some instances stigmatized. We need to keep focusing and improving on outrage and getting information and resources like vaccines to those who are most in need and most at risk. And that must include communities of color, who we know do not have equitable access to vaccines. This is especially important as early data suggests that black and latino communities are disproportionately burdened by this outbreak. We have to do better. We need to be applying what we learned from the Covid Response, and providing the resources communities have made clear they needs. Of course there is an enormous difference between this and the covid pandemic. Which is thanks to decades of investments in smallpox, we already had tests and treatments and vaccines ready to go before this crisis began. 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 getting the tools deployed where specially frustrating and inexcusable. To learn from this we need to be clear eyed about what went wrong. Not just on the challenges we face in the last several months, but that we have faced for decades. Challenges that to be frank house spent many administrations, not just this one. For example had over 20 million vials of the smallpox vaccine in our national stockpile. But they were not replaced as a expired over the course of the decades. I know i joined my number and members of this committee when i say we have got to do better. Not just on covid, not just on monkeypox, but on Public Health threats periods. Because we know there will be more. Just last week you are declaring them urgency due to polio. Another Public Health risk that we need to watch closely. I want to hear from our Witnesses Today about not just what they are doing right now to improve our response to the monkeypox outbreak, and fast, but also how we can fix this in the long term and make sure the stumbles of the last couple months never happen again. I want to know what you in the administration are doing to make sure we have enough tests and treatments and vaccines for this outbreak, and get them where they need to go. And also maintaining an adequate stock of supplies for any small parks throughout. What you are doing to improve outreach to the Lgbtq Community, address the disproportionate harm to black and latino communities, fight stigma and misinformation, and writes the inequities we have seen in our response so far. How are we making the most of new research to develop promising vaccines and therapeutics, and make them more quickly available, while continuing to pull the Gold Standard of safety and effectiveness . And are we getting schools and colleges everything they need to stay open and keep students in schools and communities safe . I am glad the cdc is providing guidance for k12 schools, and the science tells us that elements of new school kids are not at high risk. And cdc is also release resources for colleges, which is critical for students returning to campus this fall. We need to make sure the colleges and universities are equipped to prevent potential outbreaks as students move into dorms and living close quarters with each other. I realize you have got your work cut out for you and all of this especially with covid still raging, but there is no reason for us to fall behind. I will keep pushing you here because families back in Washington State and across the country are counting all of you to get it right. It is also im going to keep pushing my colleagues here in congress about the need for funding to support all of this work. I know im not the only one here of the concerns with the monkeypox response but we cant just say this is not working, without providing the funding to end this outbreak and build a Public Health system and americans deserve. I will continue to work with colleagues on both sides of the aisle and push to deliver the resources that will help get families the testing treatments and vaccines that they needs. And im interested in hearing from the witnesses on what the news is when it comes to investment in our monkeypox response. It is also important to me that we continue to keep our eyes on the horizon when it comes to future outbreaks and pandemics. And building a stronger Public Health system for whatever threat comes next. As the saying goes, an ounce of prevention is worth a pound of cure. And that starts with building a worldclass Public Health system, rather than one that lacks behind our peers. Our communities deserve to be as safe as anyone in the world, which is why senator burr and i continue to work to pass a pandemics act. Our Bipartisan Legislation implements the lessons from our Covid Response, and improves our policies and processes on issues like strengthening supply chains, improving management of our national stockpile, modernizing data systems, and other items which would address many of the challenges we face with monkeypox. But a strong Public Health systems also require strong investments. Because our Public Health system was under funded before covid struck, and it has been overwhelmed over since. We have to end the cycle of crisis and complacency but making sustained investments that allow for us to build and maintain robust Public Health infrastructure at our levels. Well keep pushing for all of these steps because we should all know by now have just how much is at stake. I can tell you that families and seattle know, parents and spoke and now. Nurses in yakama no. Workers in olympia. No people across Washington State and across the country now. Covid was never going to be the last Public Health crisis we faced. And neither is monkeypox. The question is not whether there will be a new threat, but when it will strike and whether we will be ready. The truth is the monkeypox response so far has not been encouraging. But there are some clear signs of water, and there are some clear signs that we need to improve. I dont just want to hear today about the steps that we will hear, today i want to see. Action and ill be watching closely. We walking closely on the progress and making the improvements that we need to put our Public Health security on solid footing once and for all. Thank you very much and i will turn it over to senator burr for his opening remarks. Thank, you madam chairman. Good morning. Im glad we finally have a hearing on the monkeypox outbreak as it sweeps our nation. 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. Now maybe the only thing. Since may when the first transmission was reported in the uk and europe, im impressed in the administration for strategy and appointment. After almost three years of the covid pandemic, you would think that Public Health agencies responsible for preparedness and response would be prepared for anything. Particularly a threat like monkeypox. Which weve known about for decades. And for which we have vaccines and treatments. Doctor fauci talked me before about monkeypox. It is almost a definitional case of what the cdc and our sister agencies should be prepared to tackle. The virus spreads their physical contact, it spreads when an infected person has an obvious sign of infection. This is not like covid, which was a newly emerged virus that spreads and asymptomatic infection. But by any measure, or in fact by every measure, the response from the Biden Administration on the monkeypox crisis has been a catastrophic failure. You repeated each of the stakes in the early days of the Covid Response. And the cultural arrogance of Public Health officials who were supposed to be at the forefront of the response let this country down again. Since the covid pandemic, started this committees in 13 years on the response from both the trump and the Biden Administrations. I think we are sick of being called to the carpet and us having to hold you accountable for systematic failures. But it seems nothing has changed. You cannot blame the last administration on this one. The first confirmed monkeypox case in 2022 was may 7th in the United Kingdom. The first case of monkeypox in this outbreak was reported in the u. S. On may 18th we had a warning. We had warning that this was coming. We should have been prepared to manage what came with arrived. Lets review. We failed testing. Although we 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 parents and their patients tested without having to First Consult Public Health officials. There was also a significant delay in engaging the private sector on the outbreak. Until june 22nd it took that to announce engaging with the private sector. Still to, that Companies Interested in developing additional diagnostic tests that could have helped address some of the slow turnaround times and improve access have been left waiting months for samples needed to develop those tests. Without delay. You failed on the vaccines. An enhanced strategy to offer vaccines, to at risk individuals, and known contacts, was announced june 28th. But this was already after some local jurisdictions had already taken it upon themselves to use the vaccine in this manner. On the full month of the uk joint committee on vaccines enemy as a shuns matches gets a similar strategy for their citizens. Why do we continue to be behind . Meanwhile, decisions about Vaccine Administration in the u. S. Have seem to have been made on the fly. Even when fda issued an emergency last month, allowing vaccines to be administered in thermal injections, there were no Public Meetings of fda cdc outposts. Experts discussing relevant questions on the minds of impacted americans. Which inform these decisions. Health professionals were confused about the decision and patients were scare they were being experimented on. To make matters worse, he states had no time to prepare for the strange Vaccine Administration. Right after the fda made its decision, or use state vexing allegations under the assumption that every vile would yield five doses. If we know that this has not been the case in every state. Resulting in some vaccinating more at risk people. We feel that having a plan. Monkeypox outbreaks have been occurring in nigeria and other places where the increasing frequency. It was identified as a threat. Under a threat matrix. And the threat for which we had countermeasures in our stockpile. I might also add that our earliest purchase of the bavarian ordered vaccine in bulk was in 2017. But it seems there is no real plan and how to respond with the Information Research that we needed to understand this outbreak. Only after the chair sent separate levels outlining a plan to the policy lock about the resource priorities. But it was clear it was not clear what Research Activity hss actually undertaken in response. These delays allow the disease to spread. It quickly turned it is 650 cases in june. And more than 12,000 cases in august. And near 22,000 so far in september. It should have been obvious to all of us that the timing of these early cases, coupled with the evidence that the cases were not linked. Which would create a perfect storm for a large outbreak. Monkeypox is a virus that largely transmitted through skin to skin contact. Most easily and frequently transmitted between sexual partners. Monkeypox arrived just before the price elevations across the country. One of her two years of lockdown and social distancing, your agency should have been screaming from the rooftops about what you knew or suspected about how monkeypox would spread. Instead, we remain silent. People got sick. Because of that silence. This is not rocket science. But consenting adults need to be told what Behavioral Changes 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 response is literally in the name of two of your agencies. Yet you did none of that. It was no surprise to me that the administration after months of founder in the news are that the white house could trick coordinator response. It shows where this committee passed the act to create a mission control. The secretary of hss has been totally absent. And when he has been involved it only seems to make matters worse. But new ad hoc groups within government are exactly problem. We need a consistent and coherent government plan response to be effective. That can only be led by the way, and i hope in the coming weeks will be able to get that legislation over the finish line. And ill commit to spending my remaining weeks in the United States senate, doing everything i can to help the white house set up the new office with a Lasting Mission in clear junta. If i were not retiring, i would spend the next several years conducting a third investigation which are your agencies, highlighting each and every one of the systematic bureaucratic failures that we have seen now, and seen in response after response. And imagine to belief the American People. There is a question of authority. You have the authority. It is a question of money youve been giving astonishing amounts of money it is a question of leadership. It is a question of focus. Its a question of squashing the typical bureaucratic roadblocks. Arrogance and ineptitude. You need to do better. We learned in operation warp speed that when you press outside the box, when you focus on public and private partnerships, when you get bureaucracy tamed so that it serves the American People and does not try to control them, you can actually make government work. I would ask you for your plan, when you dont have one. I would ask you for what you would change, but your agencies seem to think that they are doing everything right. I would ask you who you are going to hold accountable, but failures in each of your agencies show that you dont believe in that type of accountability. So instead i will express my outrage in hope that eventually we will get people in your agencies who do the job to prevent the American People, instead of protecting their bureaucracies. Chairman, before i close want to address a serious issue. The last time we were here there was a coordinated assault pertaining to somehow republicans were at fault for their not being additional money for the pandemic. Lets revisit some of the facts. The senate on a bipartisan basis actually passed extra funding for covid. 15. 6 billion dollars in march in the omnibus for testing frequent vaccines and global aids. Speaker of the house either cannot pass that legislation i did not think pandemic money was a priority. So she stripped out. Ive worked with her for a long time. But he sure she is a democrat. Then senators romney and blunt, along with myself engaging deepness oceans with the chair of the committee. And we reached a deal for 10 million in domestic funding for covids. But the majority leader did not want to take a vote against lifting covid restrictions on the southern border. Probably because he knew it would pass in the deal was killed. I am pretty sure truck was a democrat. So then at our last meeting, the chair in each of you got together and pretended that somehow republicans were at fault. For publicans tried twice to provide additional funding for covid. But democrats cannot take a with absence. Then democrats conducted a partisan spending exercise one republicans were not even in the room. Which dramatically raise taxes by hundreds of millions of dollars, providing funding for 87,000 agents, to audit the middle class and spent hundreds of billions of dollars on green new deals will mostly impact billionaires and and those same democrats who complain about slow covid spending did not spend a dime of those taxes on pandemic expenses. I will often hear my colleagues say that your budget shows your priorities. But democrats have the power to spend money on this and they chose not to. I guess making energy more expensive was more important. I think all of you know ive had in my jacket pocket a card with forceable requests from this administration. Ive told them all they needed to do for me to get my senate colleagues, my republican colleagues, to support additional funding. Was to provide answers to those four things. Give us a detailed plan for covid. Details are counting of where the money has been spent. Offsets too much new spending for the pandemics. And a simple vote on a covid restriction order. I first noted that in april. Today, one of those four things have been presented. To today, the administrations failed to deliver. Maybe they dont actually have transparency on what they have spent. And maybe they dont to come clean to the American People about what their plan is, until after the election. Not sure what it is. Im tired of being the one that is blamed. Ive got just as much investment as anyone in this committee in making sure that your agencies are successful for the American People. I will continue to do that whether im in congress or not. Tony, i cannot thank you enough for your years of service. It has been incredibly beneficial to the American People and to the health care of this country. I hate to see you go. But i also look forward to that day in january when we both are on the other side of this mountain, and i can actually not have to plan to fly on a monday, and they can spend some time with the wife and grandchildren. Having said that, chairman, lets have a reset this morning. Lets quit blaming everybody. And lets start showing some leadership. If the administration is, money then send us a budget that requests that. There is no increased spending for covid in next years request. They believe that this is all going to happen without an emergency. American people should be held accountable. Lets roll. Get the administration to request less work through the normal appropriations process. My hope is that there is a plan someday what they will share it with us. I yield to that. Thank you senator burr. I will now introduce todays witnesses. Doctor Rochelle Walensky is the director of the on and the administrator of the agency for toxic substances. And disease registry. Doctor anthony fauci, director of the National Institute of allergy and Infectious Diseases, and the chief medical adviser on president bidens covid19 response. Doctor robert keyla, commissioner of the food and drug administration. Dont mcconnell assistant secretary for preparedness and response. Director walensky and director fauci, kayla funnest and secretary oconnell, thank you so much for being here today. We all look forward to a testimony, they will begin with doctor lewinsky. Chairman, right Ranking Member burr, and members of the committee, i appreciate the opportunity to discuss monkeypox and the cdcs response to this global outbreak. Today, there have been over 59,000 cases of monkeypox reported globally. Including over 22,000 cases and one confirmed death in the United States. In the current outbreak the first cases were diagnosed in the United Kingdom on may 14th. And within days additional countries began identifying case clusters. On may 17th case was reported in massachusetts and was confirmed by cdc the following day. Cdc immediately began its work searching for additional cases. Educating clinicians on the public about this disease. And supporting our state and local Public Health partners in the response. In less than one week the cdc reached out to commercial labs to increase Testing Capacity and began to scale up an incident response. Over the last several weeks we have been pleased to see a decline in the growth of the cases here and abroad. Though there are areas in the United States where the rate of rising new cases is still increasing. We approach this news with cautious optimism. Recognizing that we must continue to aggressively respond with our entire toolkit, including vaccination, testing, and education about risk to inform interchange. This outbreak has been notable for transmission, primarily, but not exclusively through sexual contact. It has disproportionately affected, gay bisexual, and other men who have sex with men. With a large majority of cases in this population. The cdcs been studying milky pox for, decades and has contributed to the creation of a test experimental therapeutics and vaccines that are available today. But as a relatively rigid seas, almost no providers in the u. S. Have seen or even heard of monkeypox. Provider education has been a key component. Indeed, a remarkable challenge. But critical to our response. The cdc has issued for health advisories, each recently over 1 million people. And Host Commission outrage call by tens of thousands of commissions. Weve also shared monkeypox information for congregant living in k12 schools, to prevent monkeypox spread in the settings. , initially our Public Health Laboratory Response network labs across the country were able to collectively cast of two six dozen clinical specimens each week. Using a diagnostic test developed to detect orthodox viruses, including monkeypox. So you worked with our Public Health partners to quickly expand Testing Capacity, and engage commercial laboratories to increase capacity to 80,000 tests per week. When weekly testing volume is currently 14 of total Testing Capacity, we are working with academic medical centers, commercial and Public Health laboratories, to make testing even more accessible to all who need it. From the beginning of this response, cdc has worked closely with asper to make genius vaccine available based on their case numbers. And underlying population increased risk. Based on data from 39 jurisdictions, according to the cdc, a total of 540,000 u. S. Vaccine doses have been administered. Collaboration with communities most affected by the outbreak including the 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 their expertise to our response. To challenge us to continue to do better. And to amplify or Public Health messages. In recent weeks, cdc is providing Technical Assistance and support for Vaccination Efforts and other monkeypox response activities, at large events serving lgbtq audiences. Like charlotte pride and atlanta block a pride. Weekend. These efforts and others have facilitated delivery of vaccines to those who may face unique barriers to access, including racial, ethnic, and geographically diverse populations. The robust response required for Public Health threats like monkeypox underscores the importance of sustained investments in the core capabilities that should constitute to the foundation of the 24 century Public Health system. And addition, cdc needs additional policy lovers to enable the time the reporting of data necessary to take the informed action which the public expects of us. Despite having a Vaccine Distribution strategy since june 28th, it took until Early 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, we anticipate that monkeypox will continue to be a global threats. 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 now it is important for congress to act upon the supplemental request. Cdc will use the Additional Resources to support testing and Laboratory Capacity expansion. Vaccination efforts, surveillance, epidemiologic investigations, outreach education and global efforts. Together we can meet the vast evolving threats of monkeypox excessively, and and the current outbreak. And prepare for any future outbreaks. Thank you. I look forward to your questions. Thank you. Doctor fauci . Madam chair, Ranking Member burr, members of the committee, thank you for giving me the opportunity to discuss with you the role of the National Institute of allergy and Infectious Diseases in conducting in supporting research to address the ongoing monkeypox Public Health emergency. I will outline how longstanding niaid supported Research Efforts have enhanced our preparedness for, were spawns two, the emergence of monkeypox virus. First, i want to provide some Historical Context that relates to past, current, a future niaid Research Efforts. It is worth noting that the merchant epidemiological pattern of monkeypox cases bears a striking resemblance to the early cases of hiv aids. In the ellipses and others known in the mid countries, monkeypox is disproportionately affecting many have sex with men. However, anyone exposed to the circulating virus can get infected with monkeypox, regardless of their age, gender identity, or sexual orientation. Thus, we would be wise to heed an observation i made 40 years ago in an article i published in the annals of internal medicine in 1982. During the first year of the hiv aids pandemic. When i referred to what i would soon call aids, a disease that did not even have a name at that time. And account for that publication, and the assumption that it would remain restricted to a specific segment of our society is truly an assumption without a scientific basis. Unquote. And, so although it was focusing our efforts on the group that is most predominantly afflicted and at risk, there is still much we must learn about this disease. Additional epidemiological observational cohort studies so surveys ongoing surveillance cases of critical importance. In addition, much work needs to be done in, biology immunology, transmission, and animal reservoirs. As well as diagnostics, there predicts and vaccines, which i will address in a moment. There are certainly some sharp differences between the early years of age and our Current Situation with monkeypox. Unlike the situation of the start of the aids outbreak, the ideological age the monkeypox has been known for decades. And medical countermeasures have been developed. Namely a vaccine, genius, and the antiviral, to go violent acts or tpoxx. This is a result of decades of niaid supported researcher monkeypox virus and other monkeypox viruses it was planned prior to the current global outbreak is part of a preparedness effort to study high consequence pathogens in Key International locations, where they are endemic. Lessons learned during the response to aids and covid19 such as avoiding stigma, and ensuring the medical Counter Measures get to where they are needed most, should help us win our efforts to respond to the ongoing monkeypox emergency. In addition, the u. S. Response to monkeypox should in turn helped to inform our response to the inevitable next emerging or emerging Infectious Disease of pandemic potential. Thank you for your, tensions are be happier answer your questions following the presentation of my colleagues. Thank. You doctor kayla. Califf. Turn on your mic. They. The chair, marie Ranking Member burr, members of the committee, thank you for the opportunity to provide information on the fdas ongoing work related to the monkeypox virus, publicly marcy. The fbi has been actively working with our government and private sector collaborators to respond to the continuing Public Health threat since the first monkeypox case came to the u. S. We have been working diligently to help ensure access and proper information regarding vaccines diagnostics in treatments that for people who make the most. Theres currently one fta license for the vaccine, which is available for the prevention of monkeypox. We originally improved the vaccinee and kara vaccines for the prevention of smallpox. But following the reports of monkeypox in may the fta recognize that production for this vaccine would need to be accelerated. The fda embargo worked together to expedite the production of a supplement that can be used in the United States to make more doses. The fbi approve that supplemental line, violence faction of the manufacturing facility in europe. In august we granted emergency use authorization for inter thermal administration of the vaccine. Which is help increase the supply vaccine available two americans up to five. Folded also revealed a 2016 clinical cited evaluating two dose series of videos delivered in a bernoulli and individuals aged 18 years or older. Consistent with previous, studies an extensive experience with a similar vaccine in germany, data indicated interest thermal administration and response to subcutaneously ministration, had a modestly different reaction profile in the injection site. Its a combination of and preventative measures to reduce the risk of contact with the virus remains the best way to prevent the spread of monkeypox. The vaccine is available via intro administration for individuals age 18 years or older, determined to be highrisk of monkeypox infection, and available by subcutaneously ministration for those under the age of 18 determine to be at high risk for monkeypox. It is important to recognize that we do not have Clinical Data on safety and efficacy. So we continue to monitor safety data with that we are receiving following the distribution of jynneos nationwide. Additionally, as you heard from doctor fauci and initiated with michael trial to obtain from the data. The fda is also working closely with the, cdc manufacturers and laboratories to support diagnostic test development. Currently cdc as an fda cleared test, which can detect not girl off the pod including monkeypox by a swathe from a legion. This test is available through 67 cdc Laboratory Response network labs, as well as through five large commercial labs. In some form or some of the following the urgency declaration of hhs the fda issued an eu a foreign additional test from the commercial developer. We also issued guidance on the development of diagnostic tests, and hope it will increase the diversity and availability of tests for monkeypox. Carly, there are no fda approved treatments for monkeypox. Tpoxx or tecovirimat is an approach remember smallpox currently be made available for monkeypox under cdc expanded access investigation on new drug protocols. Tpoxx was originally improve for smallpox using the fta animal rule. The animal rule is an approval pathway that relies on animal studies, and can be used only when human trials are not feasible. Because monkeypox are remains endemic in countries around the world, we know of a large outbreak in the u. S. , human Clinical Trials about ethical and feasible, and whether they were not feasible for smallpox. Smallpox has been eradicated and is a 30 to 50 mortality rate. Without human trials, we dont know if tpoxx been official for patients with monkeypox. Drugs that show efficacy animals are not always effective in humans. No for Clinical Trials, one of which is now underway, as activists you just mentioned through the nih, will determine if the fda decides that is effective for treating monkeypox. In the meantime while there is a significant risk for the development of viral resistance, judicious use of tpoxx a careful monitoring are incredibly important for the of this beneficial drug what we saw the in Clinical Trials. Ftas doug coaster continues to ensure an appropriate response to the monkeypox response outbreak. Thank you for the opportunity to testify today in l. A. For two answering your questions. Thank you. As it conservatory oconnell . Chair murray, Ranking Member, and distinguished members of the committee, it is an honor to testify before you today on aspers work in the ongoing monkeypox response. Let me start by sharing the work asper has done to procure and distribute vaccines. The Strategic National stockpile stores vaccines that can be used as smallpox outbreak. Among the vaccines a stores are a small stockpile of a genius. A relatively new vaccine that are compromised and are able to tolerate the live replicating virus in a smallpox vaccine. And since jynneos is also license for monkeypox we have also approved for the current response. When the first case of monkeypox was identified in the u. S. , the as of us had 20,000 miles of jynneos its on an inventory and immediately deployed a vaccine to support the first cases. When they were still only two known cases in the u. S. , asper requested 36,000 jynneos vaccine vials be shipped to the u. S. From our u. S. Governmentowned reserves stored by barry and york. When theyre only 13 known, cases asper ordered an additional 36,000 files from its rivers reserve. When there are only 35,000 new cases, asper ordered an additional 300,000 vials from its reserve. All of this was done to stay ahead of the virus. The case counts were very low in the United States. We were watching the quick spread of cases in europe, about 2 to 3 weeks ahead of us. And we moved out quickly, anticipating similar spread in the u. S. In the weeks to come. So far asper has made over 1. 1 5 million vials available for use against the current outbreak. And we have purchased 5. 5 million more. To arrive over the next months. Bringing jynneos manufacturing capability on shore has been another focus by asper. The summer when they purchased the second 2. 5 billion doses from the end to be filled in finished, of contract required that these doses be filled and finished in the u. S. We have been pleased to support the arrangement with grant to film that finish in michigan. We provided grant with 11 million to secure the equipment and staff to ramp up quickly. I visited graham two weeks ago as they were bringing on this new line. I was pleased with the progress that i saw into here that they will be adding over 70 million new jobs in michigan. Vaccines are not the only medical Counter Measure that asper is made available in this outbreak. Weve also made available that prior to the start of the outbreak of the s enough held 70 million courses of tpoxx. Today, over 37 million courses have been distributed. I have been pleased to meet both of these medical countermeasures available for the current monkeypox outbreak. It is the right thing to do. But have not lost sight of the fact that both jynneos and tpoxx were stockpile for using a smallpox outbreak. Ive consulted with the who is responsible for buying hss on medical countermeasures and procurement, and theyve agreed with the approach i have taken. It is important over the doesnt move forward with the response we consider ways to preserve our smallpox capability. We also cried several Lessons Learned in the covid19 response to our work in monkeypox, as we digitize the s and s counter measuring system, and we ought to use a program that allows states to order both vaccines and therapeutics from the same system. Rather than using separate non inter operable systems for each, as they have had to do any covid19 response. Using this multi platform ordering system is a step towards modernizing our Public Health infrastructure. For the current response and for future responses. Weve also expanded a number of sites to which the s and estelle evers. At the start of the outbreak the s and us only delivered to five sites in each jurisdiction. This was more than enough for the high consequence, largescale events the s and us has been deploying to. So just hurricanes and tornadoes. However, after seeing the vanish of multiple Distribution Sites in the covid19 vaccine and therapeutics efforts, the s and as contracted to or distribution effort for its countermeasures. This is just two of the examples of the lessons we have taken from the ongoing covid19 response and applied to the current monkeypox response. Responses cannot be static. They must continue to evolve and calibrate in the set of circumstances and regularly account for new information that evolving with the scientific understanding. This is been true of the monkeypox response thus far, and will be true as it continues. Thank you again for inviting me to testify on aspirin response to the ongoing monkeypox response. I look forward when your questions. Thank you. Thank you very much for all of our witnesses for their testimony today. We will now begin a round of questioning our witnesses. And i asked my colleagues to keep track of your time. As always. Hopefully you can stay within those five minutes. I know each of your agencies have worked relentlessly to respond, first covid19 monkeypox. But i to, say frankly, too many missteps were made early on in the response, and a couple hundred cases turned into 21,004 it is unacceptable to communities already experience various access to health care, like the lgbtq and the black and latino communities. Then your hardest hit by this outbreak. Access to testing was an early challenge in the monkeypox response with many people reporting significant delays in both accessing the tests and learning the results. To continue to have these challenges around testing, it is simply unacceptable. So doctor walensky, let me start with. You has a cdc working to make sure the tests are more accessible and results are available earlier . Thank, you senator, for that question. One of the big challenges that we have in terms of access to testing is telling patients that they were presented with a new infection. And providing the understanding that this was an infection they had to test for. Indeed another important consideration was people coming in for a test when they had no symptoms and no rash. As doctor califf noted, the test for this infection is a swathe of the rash. In, fact there is no other fda approved test. We need to have a rational or to conduct those tests. So what we have, done and i should mention weve always had more capacity than we have had tests coming in. Today weve used about 14 to 20 of our capacity. But to address these access issues where to work with, clinicians patience, and to an extraordinary amount of outreach. So the providers would understand how to test. And patience with understand when to come in for a test. Our Public Health partners would know not to get keep those tests. So that was the work we did early on, as we are scaling up testing. Knowing that we may need more testing coming forward. Through the Laboratory Response network we increased our capacity to test through expanding the manual instruction to automated expansion extraction. You are commercial labs were expanded testing across the country. And simultaneously working with outreach and education to providers, clinicians, patients and Public Health. Thank you. Doctor califf, secretary becerra recently concluded that the fbis authorization process ways for monkeypox howell that improve the available of new tax and what steps are you taking to improve on that progress that youve made . First of all, let me concur with doctor walensky. There is never been a shortage of tests, but theres been a shortage of access to tests because of inefficiencies. In the system. The eua authority has enabled us. Weve given one eua already. But weve also five courtmartial hours which are offering the tests at this point. And if youre the guy thats just the other day. Which makes it clear that individual institutions that are developing Laboratory Developed tests should proceed ahead. And we have given people clear guidance and templates for developing the task, and figuring out if they work. I would say on all fronts, the gates are open. Under a watchful lie. Because we also much keep in line mind that one of the lessons from covid was that when the gates are open a lot of tests turned not to be so good. They got out. There and we have to rein the back in. I am encouraged by the decline in cases. But it really is imperative that we remain vigilant. And despite efforts by 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. People will understandably want to be vaccinated before they are exposed, but they will need more vaccines. So serious tumbles were made the scene when it came to our vaccine supply. When we got to make sure that never happens again and what are you doing to increase this distribution of vaccines right now . Chair murray, thank you so much for that question. What is important to us is that those who need access to vaccines get. So if you continue to hear from constituents unable to get the vaccine or needing to cross the border, please let us know. We are in the business right now of knocking down those hurdles and making sure the vaccine can be accessed. We go take a very small stockpile that was intended for smallpox, which was eventually intended to be freeze dried for smallpox, and converted it to those active monkeypox response. That were quite a couple of challenging problems to solve. We move the first 372,000 vials, as i mentioned in my Opening Statement, immediately. We need a few to improve and they were terrific partners moving quickly to improve that second manufacturing line. Thats began and drew the 800,000 vials we were waiting for which is what they manufactured on. We needed that approval to happen where we can deploy those and the fda worked quickly and we got those out in july. Weve also ordered an additional 5. 5 million vials of the bulk of drug substance that was intended to be law fullest for smallpox. We have ordered that to be filled and finish and ship to the United States. In 2. 5 million of those will be manufactured in the United States by adding a second lining gram of one it is on shore. The manufacturing wheel to access those vaccines much quicker than in the future. It is a critical step for the preparedness both of the monkeypox response and future smallpox programs. Senator burr. Thank, you chair. Tony. Last news mocha monkeypox here you made it very clear that monkeypox was a result of animal to human transmission. And that happened abroad. Heres a question. If we allow monkeypox to circulate in our population indefinitely in the United States, what are the chances that it has been studied whether there can be a transmission of human to animal in the United States, where we could have a threat of animal to human transmission then . Certainly possible, senator burr. Whenever you have a situation where you have an animal reservoir in the virus, and it is already shown you from the standpoint of transmission that it can infect animal species, and you actually have an individual who is infected, there is no real reason why that could not go the other way. I do not believe that we have seen that, but i would not be surprised if we do see it essentially going back and forth. That is possible. And it wasnt a real problem . There wasnt a problem of the prophet nation. When you want to eliminated infection, i mean, there is eradication. There wasnt elimination. And there is control. The best way to eradicate or eliminated it is if you keep it out of the realm of an animal reservoir, which continues to wreak feet into the human population. Great. Thank you. Don, news outlets have recently reported the administration evaluating whether some doses of should be held back in the stockpile as a requirement for smallpox rather than disappointment monkeypox response. This seems to conflict with the fdas recent decision to implement those sparing strategies. Which indicates that we need to maximize the number of available doses. Can you square this up for me . Thank you, Ranking Member, for that question. We continue to maintain our smallpox preparedness. That is critical. Our frontline vaccines continue to be available. And have not been impacted by our monkeypox response. But we have added the capability to be able to provide the jynneos vaccine to those that are immunocompromised in a case of a smallpox outbreak. And we are evaluating which each does that we make available with the monkeypox outbreak, what it means for that preparedness and smallpox. Ive met with the and consulted with them to understand whether we need a separate monkeypox stockpile. So that we can pull those vaccines off the shelf and not worry about the preparedness for the immunocompromised in the smallpox outbreak. Have you ever thought about a message you send to the average population when you suggested to them that though they are in the midst of an infection problem, we are going to discuss holding back the case, when we have a network of smallpox . Let me just explain. We know that we have 13 to 15 million a game and in this country. In the United States. Tony, we have about 1. 9 million hiv aids positive gate men. There is your immunocompromised population, 1. 9 million. Your risk pool of sexually transmitted is about 30 to 15 million. Somehow we are cheering the fact we put it some hundred thousand vaccines. If im in that community and then on top of that we have the sub normal decision, im gonna cut the amount that you get, and there is not sufficient public trans parent information about that, you have a population that is questioning whether you are doing everything to help. And that may be the reason weve only had 461,000 people vaccinated. I have a pool, a defined, pool of up to 50 million, people of which 1. 9 million are immunocompromised. Because theyre hiv possessive. Doctor califf, currently the fda switch gears really quick currently fda offers covid19 vaccines to be purchased only by the federal governments, prohibiting anyone else and purchasing these vaccines. I believe we all agree that the crucial role of vaccines and treatments play in stopping in reducing the spread of the virus. Why must every dose pass through the bureaucracy of washington before which is the patient. And why are we still restricting access 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 is a much discussion over the next period of time. But for right now those are the rules under which we thats why the plan is somewhat important. For the, chairman just one last question for doctor fauci, if i can. Wow tony, the pediatric organizations got over commands several doses of the polio vaccine before the power to six years. Old with no cases of polio in new york state, do we know how long immunity lasts . To what extent is somebody collected if they were completely fully vaccinated as a child . It is not necessarily my 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. The situation that we are concerned about is those who either had no vaccination, like we saw with the case in Rockland County in new york, or individuals who have incomplete did not complete their full course. But if you have a full course, however, since it isnt necessarily lifelong, when a person goes into a zone where there is a lot of polio, you would recommend they would get a boost. But i would prefer to perhaps the doctor walensky something for the try to. That i have nothing to add. That is exactly where we are. Thank you. Thank you senator burr, i wanted to start by thanking the witnesses and thank them for the public service. I will start with dr. Walensky. Part of the success of the covid19 Vaccination Campaign was the gradual shift from large vaccination sites to hyper local sites where people can find vaccines in their own neighborhood for example in a local pharmacy we have seen the way in which convenient and local access to vaccines can help with uptake whether they are a vaccine for a nutrient like covid19, a new threat i should say like covid19, or for routine vaccines like influenza child vexing. People now interested in doctor when providers. Doctor, how are you working with state and local partners to make sure that we reach iran whos at risk for infection . If they so choose. Thank you, senator, early on as vaccines are being distributed, we were doing it in places where people were seeking care. Many of those places where in the Health Clinic or state run clinics. It is the case that not all members of this community have told their own clinicians are about their sexual activity, it is very important that we do this in a sensitive and a stigmatized and affirming manner, we were doing and places initially are people receiving care, many of the lessons again learn from covid as we rolled out these vaccines and delivered over half 1 million to members of these communities is that we need to do more outreach. We learned that i need trusted messengers and Community Based organizations i am pleased to say that over the last several weeks we have sponsored vaccine activities in several largescale Distribution Sites like atlanta black gay pride and like charlotte pride, like boise pride. Unlike some other tech events. When we have done, so weve had really successful campaigns. In atlanta gay pride, we vaccinated over 4200 people similarly with southern decadence around 4000, 3000 people, what we need to do now is to those and smaller scale, and were actively doing that and smaller scale, rather than these big events we need to meet people where they are with Community Based organizations, trusted messengers, exactly as you say, thank you. Next question would be for both you and assistant secretary oconnell, we know that in the aftermath of the pandemic, and now its the emergence of monkeypox as a Public Health threat, the need for ongoing dedicated investment in our nations Public Health infrastructure similar to what chair murray has called for in her Public Health infrastructure to save lives act, our state and local Health Department have been struggling for years after two and a half years of the covid19 pandemic. And now with monkeypox in addition to that, they simply do not have the resources they need for routine Public Health work. When an emergency comes, up they have to move funds around and sacrifice from their core programming, other programming like the ongoing opioid academic, anti tobacco efforts. Routine vaccinations on and on. How would additional and sustained funding for local Public Health infrastructure marie help us be better prepared for new threats like a new viral i will start for you, okay oconnell. Thank you for the question. We continue to see jurisdictions and Public Health departments worn out, tired, exhausted, we know they have been working for two and a half years around the clock. We have been relying on them to distribute vaccines and therapeutics both in the covid19 outbreak as well as this new monkeypox outbreak. One of the most critical investments we can make would be an additional staffing, and not just throwing supplemental funds out that fire people that dont sustain them. Its important that we have multi year funding that supports our Public Health departments, its also critical that they can build these systems, i talked about the hpop system that we put in place for the arsonist and digitized ordering and it is inter operable and we are no longer having them trained on something called the tracks, and then each pop that, h course up, we have it on one system that talks to each other and they can order vaccines and their therapeutics. By introducing that in this outbreak we know that the states were tired. We work very carefully with them on making sure that they understood why we made this decision and why it was hard, it does push us forward in a supportive way as we face this current outbreak and future ones. Dr. Walensky, i know that you might want to say more. If i could briefly add, the core Public Health infrastructure is key. The need to be disease agnostic and long term sustainable, while other than complacency. I will give you an example that our Public Health partners in the state and local jurisdictions do not have a line item for monkeypox resources. They have had to respond has, trying to be flexible other resources, sometimes theyre not yet legally allowed. As you know, the key core Public Health infrastructure of workforce, diverse is the communities they serve, laboratory infrastructure. So we can scale up new labs quickly. And then data infrastructure, so we have inter operable data, is senator paul . Should you get a flu shot . If she had the flow for 14 days, she is as protected as anybody. The best vaccination is to get infected yourself. If she really has the flu, if she really has the flu she definitely does not need a flu vaccine. She really has a flu. She does not need it. It is the most potent vaccination, getting infected yourself. This is an ongoing question weve had ever of all being opinions from you doctor fauci. Currently antibodies serve a show that 80 of children, approximately 80 of children have had covid. Yet there are no guidelines coming from you or anybody in the government to take into account their nationally acquired immunity. You seem quite certain of yourself in 2000 and. Four and 2020, to theres a lot less certainty. One of the things we also know after looking at this for 2 to 3 years, the mortality from covid is very similar if not less than influenza when. We look at this we, wonder, why you seem to really embrace basic immunology back in 2004, how, why you rejected now. I dont reject basic immunology, senator. I have never denied that there is importance of the protection following infection. However, as we have said many times, and it has been validated by the authorization of the fda through their committee and the recommendation by the cdc through their committee, a vaccination following infection gives an added extra boost. That film that you showed is really taken out of context. I believe that was when someone called in who had had a reaction to a vaccine and asked me through a telephone in the interview if they should get vaccinated again it was in the context of someone who had a reaction. As a matter of fact, reuters factchecked looked at that and said faucis 2004 comments do not contradict his pandemic words dont lie. If you look at the words behind, a little bit at a time, she does not need it because the most potent vaccination is getting infected yourself. It is true. It is true, senator. It is a very potent way to protect. When youre trying to tell us that kids need a third or fourth vaccine, are you including the variability or, the variable of previous infections in the study . No you are not. When you have approved vaccines in recent times, the committees that are for children, you dont report anything on hospitalization or death or transmission. And the only reports that if you give them the jab, they will make antibodies. You can give kids hundreds of jabs and they will make antibodies every single time. That does not prove efficacy. What youre doing is denying the very fundamental premise of them inology that previous infection does provide some sort of immunity. Its not in any of your. Studies not of your studies for the cdc, from the government, have the variable of whether or not you have been previously infected. Lets look at adults. I have had three infections. Should i get a fourth one . Youre going to measure where youre going to get a force one, and you need one that has nothing in it. No vaccine, forced vaccine. You also need to know whether they had been infected if you ignore whether they had been infected, you are ignoring a vaccine, youre nearing a variable. What you are giving us is people decry vaccine hesitancy, it is coming from the gobbledegook that you give us. You are not paying attention to the signs. The very basic science is that previous infection provides a level of immunity. If you ignore that in your studies, if you do not present that in the committees, you are not being truthful or honest. Senator, if i might respond. I have never, ever denied fundamental immunology. In fact, i wrote the chapter in the textbook of medicine. Any of the guidelines for vaccines do, any of the guidelines for vaccines from the governments include previous infections as something to base your decisionmaking on with vaccines, do any of the guidelines involve previous infection . That is why youre ignoring previous infection it. Does not involve any of the guidelines. Furthermore, we have been asking you, you refused to answer whether anybody on the vaccine committees gets royalties from the pharmaceutical companies. I asked you last time, but was your sponsor . We dont have to tell you we have demanded them through freedom of information act. What if you said, we are not going to tell you. Ill tell you this when, we get charged, were going to change the rules, and you will have to develop where you get your royalties from from which companies, and if anyone in the committee as a conflict of interest, we are going to learn about it, i promise you that. Mister chair, can i respond to that . There are two aspects for what you said. You keep saying you approve and, you do this, and you do that the committees that give the approval are fda through their Advisory Committee. The committees that recommends our cdc and through their Advisory Committee, you keep saying i am the one that is approving a vaccine based on certain data. I dont really understand with all due respect, senator, you would not reveal which Companies Give you royalties or which company gave the other cycled royalties. Senator paul, we have to move on. Can i answer that . Briefly. If you keep asking committees, theyre not my committees, they are the committee for the fda, the acip for the cdc, i dont have any idea what goes on. You wont reveal we are going to move on because we are overtime. Senator paul, you are over, everyones over a little. Bit i want to make sure we keep on time here. For the record, i know chair murray, previous chairs of this committee, of both parties, both parties, have found videos to be out of order. I will note for the record, the video was out of order. We will move to senator smith. Thank you mr. , chair, mister chair i ask unanimous consent to submit a letter from aids united, the aids institute, the national alliance, the state and territorial aid directors, the National Coalition of directors and the National Minority aids council outlining recommendations for a comprehensive approach to the monkeypox response. Mister chair, can i have unanimous consent for that please . Yes. Thank you, very much. Thank you to our witnesses. I want to add my gratitude to dr. Fauci for your service to our country during some of our countrys most challenging times, thank you so much i want to also start by associate myself with senator murrays remarks about the importance of congress coming together to make sure the administration has the resources that it needs to respond to the monkeypox Public Health emergency and i also agree on the need to sharpen our response and to work effectively with Public Health departments, including in minnesota, assistant secretary oconnell, we had a good discussion last week about distribution of the Monkeypox Vaccine and i want to follow up on that we talked about the challenges of the Minnesota Department of health, the issue is that asper as opted to use the hpop system, the order portal, to distribute vaccines rather than the v track system, which is how covid vaccines were distributed. And what the department is used to. And i understand, it the hpop system works better for distributing both Monkeypox Vaccines and treatments directly from the Strategic National stockpile. There are challenges with interoperability, as i understand it, with the vtrack system. A course, the issue, as we discussed, by using two different systems, one for covid vaccines, and one for Monkeypox Vaccines, this is a real challenge for the Minnesota Department of health. I suspect this is a challenge for other agencies as well. Of course this is happening at a time when we use are following on Public Health departments and staff that are exhausted and burnt out after the last two and half years of responding to covid 19. And learning a new system in the midst of all of this is really a challenge. It is exasperated by the department having trouble tracking system shipments of vaccines through vtrack. Sometimes monkeypox doses were showing up unexpectedly. Could you address for me, i appreciate that you talked about this in your in testimony, could you address what steps you are taking to work with state Health Departments that are in similar situations to minnesotas to help improve how the Distribution Process is working . Smith, thank you for the good conversation. An opportunity to talk about some of these challenges. Most important to us is that those that need vaccines can get them, if anyone continues to find this to be a difficult system, please reach out and let me know. We want to knock down the hurdles to ensure that folks have access. We now have enough vaccines to meet demand. Its important people are able to access it. We have a similar challenge that dr. Walensky mentioned with the states, the states arent able to use their covid funding for the monkeypox response, we have not been able to use our covid funding for the monkeypox response either. When it came to digitizing the es s process, we were going to have to put new money into either the v. Track system or the hpop system. The hpop system is currently being used to order therapeutics. States do have a familiarity with hpop. The tracks was being used for the vaccine. Only hpop could do both. We were faced with putting annual budget funding into one of these systems in order to digitize the es s ordering. We chose to put it into the system that could do below. We believe that was in an important step and moving forward. We do acknowledge, senator smith, that our Public Health Department Colleagues are worn out and tired. We have had countless office hours with them to understand the system. If theyre running into any problems, we are available to answer them. As hard as this change management is, in the middle of two responses, it was the right thing to do to move forward to an inter operable system. We also have added additional Distribution Sites, that is one of the things we did with the s and s. We could not just piggyback on the covid19 distribution network. That was funded with covid dollars. We had to go with the s and s, an entirely new contract with different distributors with annual. Funds and set that up. That was one of the reasons why there was a delay. We have needed to overcome this, we look forward to working with congress on making response dollars more fungible in the future. I know that would be helpful, i appreciate your continuing to work in the department, of easily, getting the distribution is everything when it comes to getting vaccines and making sure the people of access to vaccines, mister chair, im at a time. I will submit a question for the record about the importance of tribal consultation to our witnesses. And i look forward to response. Thank you, senator smith, senator collins . Thank you, mister chairman. Secretary oconnell, i want to follow up on the statement you just made, i dont recall any request from the administration to use leftover covid money for monkeypox. Moreover, it is not at all clear to me that you could not submit a reprogramming request to the Senate Appropriations and House Appropriations committee for those and that purpose, what are you implying when you say that you have not been able to transfer funds, youve taken funds for other purposes and including sending it to the board. Senator collins, thank you for your question and for the conversations weve had recently about issues, weve been advised by Legal Counsel and appropriations team, our budget finance team that the money that is currently in the contract for mckesson, our distribution network, each core is managing, it could not be, we could not piggyback on that same contract to set up a monkeypox distribution network, the way the funds work, we were restricted to risk supporting Covid Response efforts. And not additional response efforts. Id be more than happy to meet with you and your team again and see if its possible to do a reprogramming. That is what we are advised, we took additional funds, different funds, noncovid funds and set up a different contract with the axon as to set up a distribution network. Let me turn to another issue that we discussed several times, i do appreciate the fact that you had made yourself available. We have statements from doctor jean, from onb back in march, that lens to decline of domestic manufacturing for covid tests. Oh and be, and its march supplemental request talks about the volatility which makes it difficult to preserve and manufacture, domestic manufacturing of tests. The doctor says the United States government put a lot of efforts and resources into building up domestic manufacturing. What we are seeing daybyday, week by, week is that that is beginning to go away. I would suggest that it is the administrations contracting policies that have weekend are domestic manufacturing of covid tests. As you and i have discussed before, the majority of the at home tests, they were manufactured outside the United States. For example, the administration awarded a Chinese Company a 1. 3 billion dollar contract, that is roughly four times the size of the contract that was awarded to an american company, abbott, a considerable presence in my state. How is it that the administration is working with domestic testing and manufacturing when you are at the same time awarding contracts to Chinese Companies . That does not help to preserve domestic manufacturing. Senator collins, domestic manufacturing of test is a Critical Mission of ours at asper, to make sure it is supported. When movement acute response to a steady state, we will always want to know whether we have had covid, rather someone we interacted with has covid, testing is critical and domestic manufacturing of tests is critical. Regarding the i help contract your call when the president made the announcement he was, going to make one billion tests available through the Postal Service distribution system, covid test not gov, he also vowed at the time that he would not interrupt the commercial market, he would not take test that were currently going to the pharmacies. And other stores. You would not take them out of the market and put them into a covid test. Gov program. An order not to disrupt that, the domestic manufacturers at the time were seeding the local pharmacies. We pulled in test internationally to not interfere with what is available at the pharmacies. As soon as that leveled out, we made a commitment in the spring to only support domestic test moving forward. That initial decision was to not interrupt the domestic test that were currently feeding the schools and pharmacies and the other pieces of the response. We wanted those to remain available. Doctor fauci, i just want to wish you well in your retirement. A very quick question for you. It is based on what you have written recently about the lessons of the aids pandemic. Monkeypox cases are overwhelmingly related to sexual transmission and men who have sex with other men, should we be doing more to look at communities spread and cases in the Broader Community . Such as, for example, testing anyone with an atypical case of herpes or shingles regardless of their sexual history . Thank you for that question, senator. The answer is yes, we are doing surveys and that go beyond well above the wellestablished and certain demographic groups. That was part of the five pillars that i mentioned in my statement about biology, immunology, transmission, reservoirs, zero surveillance. We are doing that in some of our studies. The cdc is also doing. That we are doing it in collaboration with them using some of our cohorts and collaboration with the cdcs capability to do that. Perhaps you want to comment. Thank you, doctor fauci, among our Health Advisory networks that we have sent a clinicians and our outreach, for example, to the American Academy of pediatrics, we make recommendations just like that, if there isnt a typical rash, please consider monkeypox and test for it. We make those recommendations, thank you. Thank, you senator collins, we will turn next to senator baldwin. Thank you, mister chair, first, id like to ask unanimous consent to enter into the record on april 11th 2022 article from reuters entitled fact check of faucis 2004 comments do not contradict his pandemic without objection. I want to join my colleagues, doctor fauci, in wishing you a very well in your retirement, thank you so much for your service to this country. Im going to start with you for a question, on basic research, i think we are falling short when providing sustained investments in preparedness, that is why i lead the disease act to provide sustained funding for vardy to focus on medical Counter Measures and development for viral families of concern. We cant just keep on responding to the threat in front of us, dr. Fauci, can you explain how investments in Smallpox Research have made us better prepared for this outbreak we . Had we not made those investments . Thank, you very much, for that very important question. It relates not only to smallpox, the extrapolation of knowledge to monkeypox, it relates to virtually all elements of fundamental and basic research that ultimately, when you get to a problem thats a Public Health problem, it can be applied. As i mentioned in my written and then my oral statement, the original work that had been done on the viruses dating back to 2001 and two following the anthrax attacks, when we put a lot of work into developing the countermeasures that assistant secretary oconnell mentioned regarding snow packs. It allowed us to get another type of a vaccine that is less reactive, and has less diverse events, which led to jynneos, the primary vaccine for monkeypox. The relationship between the Smallpox Research that had been done for decades on auto pox viruses and the acceleration of that research when we had the bio Terror Threat in 2001 and 2002 allowed us to respond rapidly with already developed countermeasures in the form of tpoxx and jynneos. Doctor ellens game, for me [inaudible] monkeypox is all too reminiscent of our initial response to hiv and a. I. D. S. I started my career in 1986 on the [inaudible] in that year, the cases of hiv a. I. D. S. Were reported with 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 the discrimination that was present. Dr. Walensky, can you describe cdcs efforts to work with the Lgbtq Community to combat misinformation . To reduce stigma, to ensure that folks have access to care . Thank you, senator for, that question, their involvement and integration into our response has been critical. One of the first things we did when we heard about the case on may 17th, outrage between our smallpox branch and our hiv branch. We knew it was both those communities and scientists theyre going to need to come together to make a robust response. We have had extraordinary outreach with the Lgbtq Community, we met several times with the human rights campaign, inter pride and private organizers and we have facilitated best practice exchanges with tourism hubs and we have palm cards for Province Town fire island palm springs and then we supported these large events like black gay pride, and boise pride, charlotte pride. Importantly, one of the things we did early on, this was one of the Lessons Learned from hiv decades ago, on may 27th, we First Published an iteration of Sexual Health information on monkeypox for the Lgbtq Community they would understand what practices would decrease their risk of monkeypox. All of this engaging a very robust and very active and very helpful and informed Lgbtq Community that have been essential in not only working with us but in educating their own community. Thank you. Thank you. I will enter my last question into the record. For secretary oconnell i on what aspr it is doing to ensure this delay in Vaccine Availability is not a bomb in the future. Anything you need from congress to help address this, thank you mr. , chairman. Thank you senator, baldwin i would turning the gavel over to thank you, mister chair. How is a medical resident in 1983. In 1986, two and 80 the epidemic. When hiv just exploded. I am very aware of the need to have a Robust Research and Public Health response to Infectious Diseases. Dr. Walensky, part of this has got to be predicated upon trust between the American People and the agencies, they are functioning as best they can. I feel like the trust is, frankly, been dissipated. Im sorry to say. That i respect you as a clinician. Ive asked you on multiple occasions as to what percent of the cdc workforce is actually showing up . Frankly, you have always blocked that. You have never given a straight answer. I would like to enter for the record an article from the times in which they did a foyer request to find out how many folks at cdc were actually working. Showing up, so to speak. Roughly 2000, 2772 out of roughly 13,000 employees are showing up every day. 78 are working completely remotely, coming and maybe once or twice every two months. Why is that important . First that was a noble fact, it was not shared with congress. The representatives of the American People. I think the American People would like to know that if the cdc is not functioning well, how many of the people are showing up [interpreter]. I referenced an article which i will enter for the record from the New York Times on august 17th. In which you, frankly, to your credit point out cdc has not been working well. There is a need for change. At the end of the article, they quote an acting director of under president obama, dr. Bossert, who says that it is, first pointing out that youre still working remotely, yourself, and working remotely, at least on august 17th. But then he says, its hard to see how dr. Walensky could execute wholesale changes when she only sees most of her staff at a distance. I dont know how you motivate and inspire culture change when people arent together. Cdc is requesting billions of dollars for Public Health initiatives. And agency which by your assessment has not functioning will. In which only about 22 of the people are showing up every day and in which previous obama officials are doubtful that you can effect change because you dont shop every day. I say that, painfully. I want the cdc to work. One example, im sure theres a reason, for there has been a lot of talk about the need for local agencies to have to modernize. Cdc was given 200 million for that are modernization. To be awarded to 64 different states and territorial jurisdictions. Maybe this is a chance asked, maybe this is not cdc, most of it has not yet been spent. This is according to the crs day. It is incredibly frustrating that a deliberate decision was made to not be transparent the American People. The amount of people that shown up for work, it takes a for a request from the newspaper, and i are asking for billions more, why should we trust . , thank you for that comment. I will say that we are an agency of 13,000 people. The people who need to be at cdc or at cdc, of course, laboratory workers. We have many people in the field. We have people and 60 different countries. There are many, it is just wide open. There is nobody showing. Up the offices are empty. To suggest that all these people are field workers, again, its another example of being opaque. I dont know why theyre all field workers, many of them are field workers, many of them are working at cdc and then deployed in response. Many of them are on the road. I, myself, as an atlanta last week for a day, i was in new mexico with tribal visits doing a secretary Tribal Advisory Committee meeting. Many of us are on the road. What percent of cdc employees before the pandemic actually showed up for work every day, as opposed to the 22 now. I dont have the numbers. I just feel like, when we 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 and inperson effort. Particularly, by your own assessment, the agencies working poorly. The review that we did on august 17th was to demonstrate the Lessons Learned from the covid19 response, the people the cdc are working, while they are working hard. They dont necessarily need to be on site and atlanta, oftentimes, they are more productive offsite in the field and doing the work of Public Health. Were at a time, i would just say that the former acting director of cdc from president obama, when he said in a last paragraph of the New York Times article, he did not see how you are going to be able, speaking of a particular, effect change when you only see people every now and then. He was both suggesting that it was not completed but it was something that had to happen now. And people are not working together, it made that more difficult to execute. I dont think anybody and hear or anybody watching really things that only 22 of the cdc employees showed up for work at the building every day before the pandemic. They think it is probably 78 . And now the numbers reversed. Its got me hard for me to support more appropriations until we have a better relationship and a more trusting relationship and more transparent relationship between the agency and congress what youre asking. With that i, yield. Next, senator hickenlooper. Thank you, madam chair, thank all of you for your service. One of this great challenges that the country has faced, the pandemic. Coming out of the pandemic, we see other challenges. Let me talk a little bit about covid19 and the Lessons Learned. And we learned what to do and what not to do. Again, we are back here with another Public Health emergency. I guess id ask, you doctor fauci, and i would want to echo also my gratitude and my salutations for i know you will not retire, i youre not capable of not contributing to public good. I know you will try. The Pathogen Research at an eight and a i. D. Was a big help with monkeypox. We may not have stockpiled vaccines for the next pandemic similar to covid. I am asking in terms of the next Public Health emergency, how concerned are you that this next one, the next Public Health emergency will be one that we dont have vaccines are therapeutics for . Bank you for that question, senator. We always are concerned when you get a brand new infection that you have had no experience with, you are not going to have countermeasures particularly vaccines that are ready at a timely fashion. There are two approaches to that. We have described in detail in several publications and in some of our papers, what is called the prototype pandemic and prototype pathogen response. In other words, to look at multiple families, there are about seven or eight high priority families, by families mean alpha viruses, renal viruses, other viruses, to do fundamental core research, to, for example, to get commonalities among the pathogens within a family and to start to develop vaccines and put them in phase one and have them ready to go. What the new nra technology, its very simple to switch one antigen in and out of the vaccine. That is the core of our approach right now. I think you will probably be hearing more about it, that is the thing that we are putting forth, the nihs contribution to the government wide pandemic preparedness. The prototype pathogen approach. Support that approach. The right direction to go. To make sure we are as prepared as one can be for what is untenable. The challenges of that preparation. Also the urgency. We can agree and argue about the Government Agencies across the board are going through issues or people are going to work and how, many people are working remotely, every large corporations dealing with this right. Now were going to have to process through that. In the meantime, we have to make sure we have the funding for pandemic preparedness. That is essential to the long term future of this country. Let me switch to the outbreak of monkeypox, when it broke out we had almost 800,000 vials sitting at the manufactures facility in denmark. The shipment of these critically needed vaccines to the u. S. Was held up pending, fda inspections of the facility. Even though european regulators had approved it. After caleb, i would ask you david, how can we help the fda better balanced safety protocols with the urgency and need to respond quickly to these emergencies . Thanks, senator, they issue that occurred in this case was a new plan. It had not been inspected by the fda. I probably dont need to remind you that we have more than one incidents and covid times of a manufacturing facility not being up to par. And it created a lot of difficulty and troubles. We felt it was essential to get their. We got there very quickly lubrication came from the convey hewitt and the outbreak occurred. And the balance here is the risk of vaccines which is not up to par with the time it takes to make sure that the vaccine coming out actually will do the job that is intended. Just to add, europe does not have a central Inspections Team for the vaccine facility. Each country does its own. We have had some discordance historically between findings and some of those facilities and what we have found in our inspections. We really felt we had to get this right, even if it took more time. Fair point. I yield back to the chair. We senator marshall . Thank you, mister chair, to my panel, as i read your testimony and listen to your testimony, what you described to me is an academic response to a problem as opposed to being proactive, you are being reactive. I would challenge you all to change your culture so that we are more proactive, and more of a military response to a problem like this. When i look back to the history of this, virus, july 2021, there is a case in texas from nigeria, november 2020, won a case in maryland from nigeria. We made 2022 there are cases in multiple countries all into nigeria. The moment in time before the horse was out of the barn that we couldve stopped this. I fear this virus is being transmitted from human to animal. Once its in the animal kingdom, we will never be able to get ahead of this. My question for secretary mcconnell, did you ever consider a travel ban . Growing vaccinations for people . People have traveled from africa back into this country. And then you made a statement on june the 3rd of 2022 that you said, we have enough on hand to manage the current outbreak. Do you still think that was the case then . Why is it still exploding. Thank you senator, marshall id like to take a second one first and then invite doctor walensky who has well have a lot time. Go ahead. At the time i was using this statement, were using a ring vaccination strategy, it has been effective in monkeypox outbreaks, including the ones that you just mentioned previously. It requires vaccines being administered to the person that has a virus, and then their close contacts. As the spread of the current outbreak began to indicate that anonymous partners would make it difficult for Contact Tracing to happen, we pivoted to those that are likely to be exposed. Theres plenty of vaccines the. Problems the execution, getting the vaccines to where they were needed . The strategy that we are using to vaccinate the at risk population changed as we were seeing the transmission change. Dr. Walensky, briefly, yes or no, did you all consider some type of a travel ban . Requiring people to have a vaccine before they came to the country . If i could clarify, the two cases in 2021, texas a, maryland there were no context of those were isolated cases. From nigeria . Yes, we have known monkeypox is endemic in nigeria and drc. Intimately, we have intermittent travel cases that led to no further cases. That happened in 2021. This is a different outbreak. This is may 17th. It was our first case. When we had our first case, i spoke to the commission who made the diagnosis, we called Public Health canada, the patient had traveled from canada, we immediately started outreach with our colleagues in the uk as well. There are multiple cases across europe, most unconnected not to nigeria. I want to turn to fentanyl poisoning, just a second, dr. Walensky. Two people, one or two people have died with monkeypox in the United States. Every day, hundreds of americans die from fentanyl poisoning. Why have you not declared this a Public Health emergency, why do you not ask the administration to shut down the border or 90 of this fentanyl comes from . The declaration of a Public Health emergency is under the secretary . I have to defer that comment you could recommend him it would be done. Weve had those conversations. What i will say, our ability to shut down the border at the cdc level is related to communicable pull diseases. While the fentanyl not at all. More americans are diving binational poisoning than we have lost in vietnam. This is what is killing americans every day, fentanyl. Do you not have a heart for these people . Through my career, i have cared for many of them. It is tragic. We are doing a lot. What are we doing . At the cdc, we do not have the authority to shut down the border on anything besides a communicable disease. What are you doing . Our, each community health, or doing violence, surveillance, for doing really quickly, in 2017, there had been no cases in nigeria for four years. Suddenly there is an outbreak. 218 cases, since then the cdc ecohealth, you see davis, funded by usaid were all doing research in nigeria at the time. I think its for dr. Walensky as well as dr. Fauci, were you aware of this research, what was the purpose of the . Research was it collecting are we doing more than collecting, were we concerned about labrador breaks, have a list of questions related to that. Doctor fauci, were you aware of the research in 2017 . I could get that information to you. I will have to check with the staff. I was not aware of it, myself. Dr. Walensky we, will where . We had been conducting research in nigeria for years. Id be happy to get you the details. Do you know what the purpose of the research . As i would be happy to get you the details. As i mentioned, in my remarks, we are conducting a Clinical Trial of tpoxx in the democratic republic of the congo. That is a Clinical Trial. We look for two answers. Senator hassan. I want to thank the chair and Ranking Member for this hearing in the work. Miss oconnell, i want to start with a question for you to really give you an opportunity to build on earlier testimonies. The department of health and Human Services has been responding to covid19 now for over two years. You addressed this to some extent in your testimony. Could you just explain further how the departments experience with covid19 is informing its monkeypox response . Thank you so much, senator, for that opportunity, we are continuing to actively respond to covid19 are continuing to pick up lessons as we go, one of the critical lessons is making sure that we have systems when countermeasures are ordered and where states can order both the therapies and the vaccines on the same inter operable system. We have done that now as weve disperses the acid messes ordering process. It was also important that the es s had multiple Distribution Sites across jurisdictions and states jurisdictions and states got used to that in our covid19 response the essence as up into this point has really only been able to do five distribution points in a state. Consistent with the largescale high consequence incidents it has been responding to, hurricanes, tornadoes. Now that we move to this National Vaccine strategy, we are trying to get vaccines out quickly to the high risk populations. Having those additional Distribution Sites is critical. The es s has entered into a contract now with the which will allow it to distribute to marshal places. 500 ambient, 500 frozen distributions a day for five days a week. Up to 5000 distribution points. Another thing that we have done, we have created a framework to ensure that the vaccines arent going to the wrong place, one of the things we saw when we seated the country in covid, make sure we are giving it out on a basis, sometimes would end up in the wrong place and was, not being administered. We have asked states to self test to 85 usage. Is it going to the right places . Not that a barrier. Were continue to work with states to make sure their second courses dont count against their 85 . Those that are in the field dont count against their 85 . It is been a good framework for us to make sure shots are getting in arms. The most important thing right. Now im not sitting on shelves. Thank you very much. Im going to switch to a different hot topic with doctor califf, i want to ask him on conversation weve had before on another Public Health emergency. During your confirmation hearing, we discussed how the fda helped fuel this crisis by approving and labeling opioids for long term use. Despite a lack of strong evidence supporting those labels. I was encouraged when you told this committee that under your leadership of the fda would aggressively look at really bling. In the six months into a confirmation, the fda has yet to change any labels, the Opioid Epidemic continues to ravage communities in New Hampshire and all across the country as we have all acknowledge this morning. Your agency needs to move swiftly to correct its previous mistakes. You yourself has repeatedly said that the fda needs high quality evidence to support the long term use of opioids. The agency has the authority to remove labels from drugs now given the absence of this evidence. Why is the process taking so long . I want to express appreciation for your question. Tomorrow what has been said here today we, are currently losing more people from opioids that we are from covid. This is a National Issue that we need to all take seriously. Ive taken the First Six Months to get and asset of every thats been going on inside the government. Also in the base of the fentanyl mail order issues that are going on with high dose fentanyl. None of that money we published our framework last week. You will see changes over the next few months within the context of that framework. Are you telling me that you are considering the framework calls for real labeling opioids, active consideration a discussion within the fda, yes. Look, i was just at a recovery rally in my state, with people who have engaged in peer to peer recovery, people who are helping pregnant women with their recovery, the people, parents, who have lost two children to fentanyl and to opioids. The fda first approved and labeled opioids for longterm use more than 25 years ago. That means they have been on the market for more than 25 years without substantial evidence that they are effective for that purpose. With plenty of evidence about the harm that these drugs can cause. I appreciate that there is a framework out there. What people are looking for right now is action and i will continue work and my colleagues on both sides of the aisle to make sure it happens. Thank you for your service. Senator rosen . Thank you chair murphy for holding this important hearing and thank you for being here and doing all that you do in these trying times. That is for sure. I want to talk a little bit about the clinical guidance for all our practitioners, of course, support staff, to prevent and treat monkeypox. I would say many clinicians, lineage majority of clinicians, have not directly treated monkeypox, they have not seen a wide range of cases, it is critical for guidelines to be wildly available to all medical professionals, i would also say their support, staff who dont to do it is important for treatment and prevention. Regarding monkeypox prevention, i have concerns about not just the slow rollout of vaccines, vulnerable populations, i appreciate that you have been doing significant work to make the vaccines more available. With all these vaccines rolling out, there is new covid vaccines, flu vaccines, theres an ammonia, theres a shingles, of course, theres other things that people might get tetanus, this or that, for adults. A lot of confusion about boosters, can i combine . Vaccines i am really concerned that the cdc, doctor walensky, what are you doing to mount the Public Information campaign on the wide variety of vaccines, the ones available. We dont want someone to my parents with had shingles, it is very painful. Hurry going to do that . Pharmacies, public spaces . Besides our doctors, people may not be going to a doctorate clinic. Maybe theyre going into their local drugstore, Grocery Store every week. Thank you, senator, for that important question. I think one of the things you raised is one of the challenges that we have seen, first with, covid now with monkeypox. One of the places i would really welcome convert congresss health. We dont have a mechanism in this country by which we informal clinicians of a new outbreak or new disease. This has been through a lot of public education. We have had a massive amount of outreach. We have had Health Advisory networks that we reach out to, when we put out a Health Advisory, we have done for from monkeypox, they reach about 1 million clinicians. We have done what we call clinician outreach webinars and cocoa calls. They reach about 6000 clinicians, we put them online, they reach about another 10,000. Each one we do, weve done several of those. I personally have sent a letter to all border clinicians through the double amc working with each state to try to send letters outer to inform people of a disease that they may have never heard of it may have never seen. Tomorrow, that might walk into their clinics. What do they need to know . What are the protections that they need to take . How are they diagnosed and cared for patient disinfection . That has been a lot of the work that we have had to do during this outbreak. I will say, from a Health Workers standpoint, at least as far as monkeypox is concerned, we have seen very little outbreak and Health Care Workers. We have had one diagnosed Health Care Worker after a needle stick injury. We have seen very little Health Care Worker outbreaks due to our personal protective equipment and the outrage that we have done in telling Health Care Workers how to protect themselves. What about the broader idea that we have so many vaccines that are available to the adult population, they are preventative vaccines that we normally have, flu, shingles, pneumonia, now the covid booster, we now potentially have a monkeypox shot, how are you going to get this out to patients and consumers, the people . We do a lot of provider calls for that as well. Our Advisory Committee what if you are not going to provide here . How are you when you get it to the average person . We have been doing press conferences. We have been doing advisories as we have rolled out both boosters. We have a massive flu campaign we rollout in early october. We will again do that this year. One important thing that i want to highlight is that we had a cdc, we in this country, we do not have a mechanism like we do with children. We you listed at all vaccines, i believe there are 13 of them that are advised. We do not have a mechanism in this country to finance adult lachine the way we do have vaccines for childrens programs. When we look at the equity of getting vaccines to rural populations, to other populations, we do not have a mechanism by which to do that in an equitable fashion the way we do for children. That is a big constrain that we have right now. Thank. You only have 20 seconds left, doctor fauci, i want to ask you this quickly. We have monkeypox, a medication to treat the infection, but there is also some to management. We hear a lot of talk about opioids. I know it is very painful, monkeypox. I dont know what the treatment might be. What kind of guidance are you giving the medical community about effective Pain Management as it relates to the neuropathy that monkeypox causes . There are medications for the neuropathy. Most importantly, when in it as on the surface, the rectum or the yuri threats, it can be extraordinary painful. We recommend, and hospitals do this anyways, i think this is common knowledge, it is an acute not chronic pain. It is the kind of thing that you would not hold back on any type of pain medication just because you are concerned about addiction. The discussion that we have been having about fentanyl on the opioids, that is not using it for chronic pain. This is not chronic pain. This is very acute pain. It usually resolves itself within a period of a couple of weeks. You certainly dont want your patient to suffer inordinately by holding back pain medications. Similar to that, anal shingles in that same way. Thank you, my time has expired. Thank you. I will recognize myself for questions. I have to, one for doctor walensky, one for dr. Fauci. Doctor walensky, one of the things i panic about is your access to data. You have talked to this committee about it. We have talked personally about it. Outside of emergency use, you are stuck in a position today where you have to negotiate 50 different data sharing agreements with states all over the country. We expect a lot out of the cdc. It is hard to expect too much from the cdc when you dont have the authorities, as i understand it, to get that data that you need absent an emergency. We look at what is happening today with monkeypox. You are getting data. It is patchy. For instance, you are not getting full Demographic Data. There is a lot of states that are not reporting to you. For instance, there are breakdowns of cases on race, ethnicity. That, you know, it really hurts our ability to target who gets the vaccine, who gets resources. It is certainly in the context of monkeypox. Maybe more broadly, what position does that leave you in when you dont have the authorities to be able to compel states in a uniform way to get you good on a . Thank you. Thank you for your thank you for your leadership. We are trying to get authority to provide this data to you. We have been working closely and tirelessly with state and local staff. They have been doing the same to extract data on this outbreak specifically. We actually negotiated 60 wanted a years agreements. We have navigated bureaucratic approvals to get flowing. We set up voluntary arrangements. There were large commercial labs. They send their data. It has been hard. If we cant make informed decisions based on the best possible data coming into us, we are nominating the best decisions for the American People. The existing patchwork of data systems is not working. It is not working to the best ability of the American People. For monkeypox specifically, i can tell you that i dont know the total number of people hospitalized with monkeypox. The data on Laboratory Testing in the United States, the complete Demographic Data as you noted, people with monkeypox have been vaccinated. We cannot link the data to the other data. We are 27 of our data on testing. We received 47 of our data on cases. 91 of our Demographic Data because of these data use agreement on vaccination. I would much rather have you be in the business of letting the public has presented of the country then in concert negotiations over that a chairing agreement. That seems like an essential function of the federal government is out of a uniform way in which you get data. Rather than put yourself in a position to negotiate over and over again. There are these deadly use agreements. My hope is that soon will be able to find a consensus on that here. Scary that you dont know when people are hospitalized of monkeypox because of your inability to get that data. Doctor fauci, in a minute and a half remaining, i want to talk a little bit about it. What we learned, what you learned over the course of the information Distribution Campaign for the covid vaccine, talk about how that relates to what we are communicating about others. 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. A colonel if this was necessarily your fault. In the euphoria of early news of the covid vaccine, we probably got out a little bit ahead of ourselves in terms of what level of protection it could provide. What are we learning about how to talk about the vaccine . There is the early distribution stages. How does that inform how we should talk about the Monkeypox Vaccine . Well, first of all, those are two entirely different pathogens. The response and the durability of the response to each is really quite different. It was a rather unique situation with covid vaccines. There was no deal that the original protection against symptomatic disease and severe disease was well into the 90s. That was the really good news. The sobering news was the durability of protection. Particularly against infection and some disease. Fortunately, the durability against severe disease lasted. Look at coronavirus in general. There is usually a good parameter of what the response to a vaccine is. Even with a coronavirus infection. The durability of the protection against reinfection long before covid came along, just the typical common coronaviruses. It did not vary it did not last very long. We see instances of reinfection with the same coronavirus. Poses a very different situation that leads to the need for an importance of updating vaccines. Giving the boosters that are a part of the regiment in addition to the primary regiment. When you are dealing with the pox virus, pox viruses have a much greater durability and protection. We know that because the smallpox itself, once you get infected, you are essentially protected for life against reinfection. Once you get vaccinated with the standard of smallpox vaccination, you can be sure that the durability is measured at least in decades. Maybe in lifetime. What we are dealing with now, it is likely going to have a durability of protection if you get the two doses. Not just won. We want to make sure the people get their two doses. The durability is likely going to be much greater than the shortened the ability of the covid. They are fundamentally two different viruses. Thank you very much. Senator . Thank you. I have two questions. First for doctor walensky, and then for doctor fauci. Over the last two decades, we have issued only for Public Health emergency declarations. H, zika, opioid crisis, and covid19. On august 2nd, they declared monkeypox a nationwide Public Health emergency. Of the over 20,000 people diagnosed with monkeypox since may of 2022, there has been one fatality. I am concerned that the Public Health emergency declarations will not be taking seriously if it is a litany for every new challenge that comes along. You need to get the public to buy into it. A lot that i would like to ask, what are the criteria used for determining whether a disease or disorder constitutes a Public Health emergency . Thank you for that question. Incendiary, what we are seeing in late may, early june, it was the doubling time of this new cases. It was about every eight days. An increased number of new cases. Among the things that is important as we understand when a Public Health emergency exists, i will invite these assistant secretary to chime in here as well. One of the what things are a lot for us to do . It could be in flexibility of funding and resources. It could be in emergency use authorizations. It could be in other flexibility so that we have the capacity of as an agency to deliver as much help as possible. I dont know if the secretary oconnell wants to chime in their. Just concur with what doctor walensky said, they created an atmosphere where the fda was willing to use emergency youth authorization in authority. It was easier for states to give us the data that senator murthy and dr. Walensky talked about. It makes it easier for local Public Health departments to shuffle employees around in order to put them towards the current response. It created some flexibility. It was also an important signal to the community that we are paying attention. This is an emergency in our view. We want to provide as much countermeasures and response mechanisms as possible. It also aligned with what w. H. O. Did. They declared a Public Health emergency of international concern. We have the most cases in the world. This is consistent with what their determination was. Ultimately, it is the secretarys decision. He made that decision in august, as you said. I was with this gentleman. I agree on all the things that were unlocked. The point is that we need to keep looking at the emergency capacity. We are planning for. It i think we all agree that we need to keep looking at this as a continuum. With Climate Change everything else, there is gonna be a lot more of this to come along. They basically agree with that conscientiousness. Being ready for it. You do have to keep in mind that if it does enter some type of sequence where gets dismissed, it is being declared too often. To me, it looks like you want to develop some criteria that, i know it is difficult to get everything into a subset, but i worry about how people are viewing it. It is a litany of Public Health crises. We went through the covid19 journey. We learned so much about it along the way. Of course, this was a last time that doctor fauci and i spoke. We are talking about shutting down the economy. You said that we did that out of uncertainty. We would probably never want to do that again. That cost trillions and trillions of dollars on the way. We surely have learned a lot with that experience. We might use it on others. Doctor fauci, a lot of americans are worried what the power of social media. It was over a year ago. It was in july when we talked about the contact. Here recently, a federal judge ruled that the Biden Administration, including yourself, it must turn over external communications with social media companies. We will see what happens there. There had not been any contact up to the point. Any social Media Company contact since july, that is when we spoke last, and it has been a decent amount of time, i am just curious. I dont believe i said there was no contact. I have had a, over a period of time, and i have to check the dates, but i need to get those correct dates. Mark zuckerberg of facebook had contacted me to make some Facebook Live discussions about encouraging people to get vaccinated. He discussed how we can make sure that people understand the importance of vaccination. There has been. That is public record. Anybody who has access to the public face of facebook would see. It was over three conversations that i had back and forth with him about it. It was about promoting the use of vaccinations as a Public Health intervention. On that particular Public Health advice about the benefit of the vaccine, that is probably not where the contention arises. I want to narrow in on this. This could be a regional discussion of where it came from, the lead. And then they used the wet market. Was there ever a discussion on that . To me, that is a differing kind of issue. To my knowledge, there was not. I want to make sure that i get the question correct. If the question is, are we influencing social media in any way . The answer, no. Any communications that are made in that regard, as far as im concerned, they are an open book. The lawsuit that you mentioned, i think it is missouri and louisiana versus biden, the cdc, the fda, the entire government. It involves the president. He is under the department of justice right now. I have handed over every document that the department of justice has asked for. It is up to them to make it available. I have nothing back from anything that i was asked to provide. Thank you. We have a vote pending. I want to turn it over. Thank you. Thank you. Let me conclude i, if i can, i want to thank all of you. I want to thank your forces for the work that you have done or the last three years. Tony, i wish you well in the transition. I want to stay. This i want to be perfectly clear. We do not attack or react fast enough. Ill say that again, we dont act or react fast enough. We have been focused. I will do a weak lap really quick. May 17th, affection in the United States. We see this. We already own i ate big bulk storage of vaccines sitting in denmark. They apparently sped up him something that was not supposed to go online until sometime in the fall. They applied to the fda on june 30th. It is july 27th before the approval is made. Here is the concerning part, it is april 18th when we signed the deal for domestic finish somewhere else. Ill say that again. We start in may, we know we have domestic infection. We are concerned with our ability to deal with this. There is a big period where we do not look for domestic finish. I am not asking for a response. I am just making a point. If we have a Pandemic Response plan, things like this get resolved. I dont know what the limitations are that have been placed on any of you about sharing the specific plan. Whether it was on covid, whether it was on monkeypox. I dont really care. What i do care about is that if you are in leadership with the agency, if somebody else is in a role of leadership in the future, the first thing they should be saying is let, sit down as a group, lets put together a plan, lets know what everyone else is going to do. This independent turf war that exists, we own tesla, we own this, we own out, to with it. When you declare a national emergency, this is no time to collect territory in turf. If you need something change or reprogrammed, ask us. Dont use this as an excuse as to why you could not do something. We show, we have reached out many times. The only thing i hear is money, money, money. Listen, listen to what the doctor said to you. When 78 of your employers are not coming into the office, you do not get much sympathy from us. It may be the wrong time to do a demonstration about working remotely. The biggest struggle we have god is putting people back in the office. The government is not capable of doing. In the private sector struggling with it. Post covid is very different. The responsibilities that you have as the Emergency Response component has not changed. You have to look at your workforce. You have a look at the challenges. You have to look at the appreciate years that you have in place. You need to say that you are learning from the last one. I am not going to be here to say this again. I am not sure parity will hold another hearing from now to the end of the year. I want you to know that i look forward to working with you. I will continue to be resourced and review. I only have one goal. That is that i know for the next little while, this is a lot faster than we did. We have to do much better than we did on monkeypox. That is when this gets out of control. There could be massive amounts of loss of life. Mister chairman i, thank you for your indulgence. I probably missed the boat. That is okay. I like this more. Thank you. Senator, thank you to the committee for participating. Thank you to all of our witnesses. Doctor walensky, dr. Fauci, miss oconnell, thank you for that is really important and awful discussion about the response to the monkeypox outbreak. For anyone who wishes to submit additional questions, the record will be open for ten business days. The committee is pretty generous. Ten business days. You have untold number 28 5 pm for additional questions for the record. This committee is adjourned. [noise] [inaudible]
vimarsana.com © 2020. All Rights Reserved.