Large event pilot has been incredibly successful, 3300 shots were administered in new orleans, one thousand shots were administered at oakland pride and 4,000 shots were administered at black friday in atlanta, we were notified an additional 1500 doses in the days and events following charlotte pride last month bringing the total Vaccine Administration as part of the Pilot Program to nearly 11,000 doses. These efforts are reaching black and brown communities, top priority of this administration. By vaccinating thousands of people at high risk who might not otherwise have gotten a shot this program is working to advance equity and combat this outbreak. We continue to build on this work by making additional Vaccines Available for large and small equity interventions across the country which we will talk about more. Stepping back, we are seeing the impact of the administrations conference of strategy to combat monkeypox in the latest case trends and other promising data points. Case numbers are down 50 since early august and in places like atlanta where we worked closely with the Public Health community on the information around events like black pride the new cases of steadily declined and in dc the new cases have declined 20 on average per week since a peak in mid july. Knowledge of our tools and interests in using them has increased. According to Research Released today from the university of pennsylvania, and knowledge of the Monkeypox Vaccine has jumped from 1 3 of americans to 60 . The risk profile and behaviors for monkeypox, nearly 3 quarters of americans said they would get vaccinated if exposed to monkeypox. This shows us that our work to expand knowledge of monkeypox and our tools to fight it alongside so many local Health Departments and other Community Organizations is working. We know there is a lot more to do especially for black and brown communities where the burden remains high but theres no question work weve done to rapidly increase vaccine supply, get people vaccinated, wrapup the availability of testing and treatments and educate individuals on how they can protect themselves is making a tremendous difference. The Administration Strategy is working and as you will hear, we will continue to work nonstop to get more shots in arms, more information to the highest risk individuals and learn as much as we can about this virus and our treatment so we can quickly and effectively end this outbreak. With that let me turn to doctor fauci who will talk about Clinical Trials recently launched to make sure we can effectively treat those who have contracted the virus. Talking to you about what bob mentioned but also getting somewhat of a brief overview, if i could have the first slide, the Research Priorities for monkeypox which generally and broadly all under 5 major pillars, there are a number of Unanswered Questions so as we implement the interventions that we have simultaneously, we pursue some Unanswered Questions, namely, addressing gaps in basic virology and immunology and immune, understanding better transmission as well as the issue of animal reservoirs not only potentially in the United States but also globally. Also the importance of developing newer diagnostics particularly diagnostics to be able to determine if we can see if a person in the nascent radical presynthetic stage that doesnt have an obvious lesion, is there some diagnostic tests that we can do to alert us to that and therefore help stop the spread. Also to evaluate new treatments. I will speak about one of the treatments that we have and how we are improving our knowledge of that but the development of other antiviral drugs and finally and importantly to optimize and advance our vaccine regimen, next slide. What im going to mention in the next couple minutes are two significant Clinical Trials, one in therapeutics and there are two trials within that category, when in the United States and one internationally and also take a look at the vaccine studies we are doing. If i could have the next slide. In the United States we are conducting and it has already started on september 8th, a phase 3 trial for monkeypox in the United States. That is referred to as the stomp trial standing for the study of to cover them at for human monkeypox virus. As you know, the tea pox is approved for smallpox by the animal rule but monkeypox, it is still under an expanded access ind, so the plan will involve more than 60 clinical sites in the United States for the target enrollment of 530 people. We are going to randomize people to to want to receive tea pox versus placebo. A very important aspect of this that we learned from our experience in the days of hiv is to get the community involved, being able to determine what is best for them so that in the trial there is an open label segment which will unroll children, people at risk such as pregnant individuals, breastfeeding individuals and others with severe disease so if a person has severity of disease, they can be in the trial but they will be in an open label component which there is they will receive tea pox. More information about this trial is shown on the link on the slide. Next slide. In addition to that, the phase 3 trial, for monkeypox in the democratic republic of congo. Recall that when you look at the different clave is the congo clave is clade one which has a higher degree of mortality that they have experienced with is that compared to the very low degree of mortality in clade 2s that are currently in the United States. This trial again is a randomized doubleblind placebocontrolled trial that will open imminently, led by the and i an idea as well as the democratic republic of the congos National Institute for Biomedical Research again, the target is 450 adults and children, 3 kg or more come with Laboratory Confirmed infection. Pregnant women are eligible in this particular study because of the risk that is ongoing and actually practical now in the drc, in that study the participants will be randomized one to one and assigned tea pox or placebo for the 2 times a day for 14 days. Given the severity of the disease in the drc, all participants will remain in the hospital until recovery. Next slide. Finally a trial for Monkeypox Vaccine. Monkeypox and smallpox are given subcutaneously and that has been approved by the fda but the Intradermal Administration is still in aua, this trial opened on september 8th, the target is 200 individuals from 18 to 50 across twee eight United States sites, participants will be signed at random to one of 3 studies, either the standard, licensed regimen administered subcutaneously, but there will be two separate doses, 1 to 5 of the standard dose that was recently authorized by the fda and 1 to 10 of standard dose administered, the 1 to 10 is to determine because in the United States we have enough doses to handle people at risk but this is a global problem and we are going to make a contribution if in fact 1 to 10 works, that will immediately double the amount of doses available on an International Scale and we are going to determine whether the peak responses introduced into the recipients intradermally are as good as those with regard to the licensed subcutaneous regimen. Also there will be Additional Data on the relative safety and tolerability of the regimen and finally more information on these trials can be seen on clinicaltrials. Gov. I will handed over to doctor walensky. Thank you and good morning. I would like to share the latest data on the current monkeypox outbreak. As of september 14, 59,600 cases have been detected globally in 103 countries. In the United States there have been nearly 23,000 cases of monkeypox identified across all 50 states, the district of columbia and puerto rico. Over the last several weeks we have been pleased to see a decline in the growth of new cases here and abroad though there are areas of the us where the rate of rise in new cases is still increasing. We approach this news with cautious optimism. It is a result of education efforts, work being done to vaccinate at risk individuals and people who have made informed decisions to make temporary changes to their behavior to protect themselves and their communities. We recognize that we must continue to aggressively respond with our entire toolkit. Over the past several weeks weve seen the racial and ethnic makeup of this outbreak evolved, monkeypox cases were first seen predominantly in Nonhispanic White men, in the last week among cases for which we have race and ethnicity data, nonhispanic men represented 38, nonhispanic black men represented 38 of cases, latino or hispanic men represented 25 of cases and Nonhispanic White men represented 26 of cases. We continue to closely monitor data on this outbreak, those at risk and how prevention measures are being used. Yesterday cdc posted no Administration Data by jurisdiction. In addition to reporting aggregate Vaccine Administration data, age, sex, race and ethnicity, these newly available data display total doses administered for each of the individuals 39 jurisdictions for which we have received data. We continue to work closely with additional jurisdiction to make their Data Available in this report. To date 540,000 doses of vaccine have been administered across 39 jurisdictions reporting data. Over the past few weeks we have seen an increase in second doses administered as more people have become eligible for the second dose. Specifically 28 days after their first dose. As a reminder, this is a 2 dose vaccine and it is important to receive the second dose to have the best protection against monkeypox which currently suggests a 14 days after the second dose. Working closely with jurisdictions to provide the most complete picture of who is getting vaccinated we ve been able to receive data on race and ethnicity for 91 of the first doses reported. Among the first doses reported, those who are white represent 47 of people who receive their first dose, those who were hispanic represent 21 and those who are black represent 12 . Giving the data i shared earlier on demographics, the percentage of vaccines administered to latinos or hispanic men and nonhispanic black men are disproportionately lower than we are seeing represented in cases. Discredit culvert education, vaccination, testing and treatment are equally accessible to all populations but especially those most affected by this outbreak. Cdc remains committed to collaborating with jurisdictions to reduce health disparity. In an effort to allocate Monkeypox Vaccines more equitably, to reduce racial and ethnic disparities in vaccinations and to overcome systemic and structural barriers the Us Government launched two Pilot Programs to provide vaccines to populations at risk, which we will outline in more detail. We have already had success with this approach, with a Pilot Program for vaccination at large gatherings that was announced on august 18th. So far through this program Monkeypox Vaccines have been administered to over 10,000 people at large events including southern decadence in new orleans, atlanta black gay pride, charlotte pride, boise pride and oakland pride in pride fest. This new Monkeypox Vaccine equity Pilot Program will expand these efforts to engage with communities in smaller events and intervention focused on addressing disparities. The application process for the program is open and available on cdcs website. At cdc we continue to Prioritize Health equity and all of the work that we do. Im very proud of the work to launch the new Vaccine Equity program and the opportunity for equity it presents. Thank you and i will turn it over. Thank you, doctor walensky. As doctor walensky and mr. Fenton mentioned we see encouraging signs in our fight against the monkeypox outbreak with cases trending down, down by nearly 50 since its peak in early august. There is more work we are doing to reach our community at highest risk i want to be clear this is the result of our hard Work Together to increase the availability and testing, make vaccines readily available to people who can benefit most, providing guidance on how to avoid monkeypox through changing behaviors and the community has done it. But as you are hearing our work is far from over. As we have said, equity must remain the cornerstone of our response and currently some jurisdictions see increasing rates of monkeypox infections while others are seeing a decline. We are also seeing that monkeypox cases are concentrating in gay, bisexual and other men who have sex with men of color, most vaccines have been administered to white men. Early adopters as we see in the data have begun or completed their vaccination series. We are now entering the harder phase of the Vaccination Campaign where we need to work to make sure we continue to get first doses into arms and access for second doses. That means we need to use hyper local strategies that let us reach deeper into the community. The largescale of that intervention focuses on events resulting in 11,000 doses of vaccines getting into the arms of people who might not have sought services in more traditional places. 63 of vaccines out located for these events of gone into arms. In georgia nearly 70 of the people who were vaccinated at black pride identified as nonwhite. 50 of the vaccines administered were 2 black people. These interventions are working at as you heard we have more coming. As i said before these largescale events are only one lever but we know sustained Community Outreach will make the difference, that is why today as you heard we are Opening Applications for our second equity intervention pilot that focus on smaller projects to link to Monkeypox Vaccines, education, testing and treatment. Health departments will use their local experience in connection to the community to identify hyperlocal strategy to improve Vaccine Access to communities of color, those that are overrepresented in this outbreak. Cdc will provide with vaccines, materials and Technical Assistance needed to realize local interventions and it will help us learn what works to get needed Monkeypox Vaccine and services to populations. We have allocated 10,000 files up to 50,000 doses of vaccine for the smaller equity interventions. The application is going to be available on cdcs website and the administration will be promoting the new Pilot Program through direct communication with Public HealthCommunity Partners in social media. Our data tells us monkeypox is not an infection that exists in isolation. It travels with hiv and other sexually transmitted infections. 61 of people diagnosed with monkeypox either had hiv or sti. We quickly used this data to change how monkeypox is supported by Public Health department clinics and communitybased organizations. Last week cdc communicated to these funded Health Department and directory funded hiv communitybased organizations that their hiv staff and dollars could be used to help us end the monkeypox outbreak. The same people we need to test for hiv and sexually transmitted infections and lead to prevention and care are the same people who need monkeypox related Services Like testing, education and vaccines, this important change in guidance to recipients allows our frontline Health Departments and communitybased organizations to use their hiv and suv resources to accelerate us to the end of a . Box outbreak. For the exact same population. This is just the latest example of us being responsive to what is happening on the ground and pivoting our focus and resources where they are most needed. Thank you. Thanks, doctors. Lets open it up for questions. A few questions, first, lets go to afp. Thank you for taking my question. The trends look good but where what do you attribute to that . Is the Vaccine Campaign paying off mostly and how confident are you to see a rebound and secondary to that, the certain level of spilling into wider populations like pediatrics. Thank you for the question. First we should note that we have made strong progress and we are encouraged either case rate of rise declining and yet we are keeping our gas pedal heavily downward pedal to the metal as we continue our activities to continue the vigilance. I attribute it to the multilayered approach of all the things we are doing, the testing we scaled up, massive amounts of education, vaccinations we have been able to get out and we are working to get harder to reach communities that might not have been first in line but slower to uptick and where all of these pilot activities are. Let me add to that question. I will just say again this is the toolkit and you have to use every tool in the toolkit which we learned from so many other infections including hiv. The behavior change, the vaccine, testing, messaging, and the equity focus are all strategies that are going to lead us to control of this outbreak, and address the question about spread to other populations so we have vigilance for that with our surveillance and cdc can speak to that. What we are seeing is terminal change in those populations, its not an Efficient Group that is transmitting, knowledge is important, anxiety is not so awareness is what matters. We have done extraordinary outreach to providers, guidance with k12 educators, University President s, Health Educators to know what they are looking for, should a patient come in and we have really seen terminal change, we generally dont see extension in those settings. We will take another question. Madison muller at bloomberg. Thanks for taking my question. You said you are keeping the gas on the pedal and honing in on ensuring the infections continue to go down and im wondering what the strategy is going forward, youre focusing on what you are doing to ensure there is no complacency and the we continue to drive these cases down. This is bob. It is all of the above, all the tools, continuing to make sure the vaccine uptick continues to approve and we continue to work to vaccinate especially those that are hardest to reach and bring vaccine to them through these interventions. Let me turn to doctor walensky first and you can speak to more detail about those efforts. Providing those vaccines, the education every single one of these large events there has on a massive amount of resources, education, folks on the ground teaching people in the community how they can protect themselves, what behaviors might lead to more infection, how to lead to less infection and the more we do that the more the knowledge increases, when we have a knowledge increase as as mr. Fenton just noted we see communities understand how to protect themselves, the behaviors that increase risk and how vaccination could decrease risk. It is outreach to providers and clinicians so they know what they are looking for and for the community. I will start by saying what is exciting is the Administration Strategy is is working. Doctor walensky and mr. Fenton have been clear, and about treatment and vaccines. And you dont just use one toolkit to build a house, we are using all of them together and some really positive news from the university of pennsylvania that says our messaging is coming through and cautiously optimistic good news from the perspective that we are seeing numbers of the outbreak, we have the hard part of the job to do, the early adopters of listened, we need to hanker down and get deeper into the community as we are doing, and the work the jurisdictions are doing outside of these equity pipelines. One other thing that is important which we keep talking about the lessons we have learned from hiv that are positive lessons. Back in the day when we were seeing patients in the 80s when we were telling physicians to ask questions of patients that they would not have asked before like uncomfortable questions about sexual activities which the diagnostics were up there. As doctor walensky said when you go to the providers and tell them to be alert to things they may not have otherwise looked for, that is a good way to into the question that was just asked about how do you make sure with surveillance that you pick up things that might be in the community that you didnt see before. It is an important lesson we learned from hiv. It is important to say we are not the only ones who have our foot on the gas pedal. The community has their foot on the gas pedal too and they are really helping us both from the perspective of addressing the outbreak and the perspective of getting the research we need so we understand how to use the vaccine in the best possible way so it is and all of society effort, not just government and kudos and cheers to the community for putting their foot on the pedal. They have been invaluable partners. Thank for those responses, lets go to another question. Chris johnson. Thanks for taking the call. You talked about how equity is the primary focus of the administration efforts, but we are seeing numbers where new cases are shifting increasingly among men of color. Why do you think these efforts for equity are not having an effect of raising equity in these cases . Let me start with doctor walensky and we will go from there. Walensky this is not uncommon for many Infectious Diseases and it is why before we even saw those shifts we embarked on these activities because we anticipated this might be happening and it is for these reasons we started on these pilot projects before we saw shifts in data. As is often the case put Infectious Diseases we have or vulnerable populations, racial and ethnic minorities are impacted later on so what we anticipated, we have embarked on these activities to address this in this moment. Ive spoken to providers on the ground and promoters of these events to have noted that this effort is unprecedented in terms of reaching these communities. As doctor walensky said, all the commitment in the administration is to focus efforts on equity, to resolve the issues we are seeing. It is a hard effort and the challenge and the way to address equity is intentionally and this is a way to do that. Can you see if we have another question . Thanks for taking my question but i have a question on research. You listed five Research Priorities focusing on vaccines and i want to know are there other trials to understand basic virology, transmission, anything available for the Research Agenda . Two parts to your question. When you talk about other basic questions that i asked, they are not at the level of Clinical Trial. What we will be doing is developing the tools that will ultimately get translated into and implement will Clinical Trial but when you are talking about fundamental basic virology and immunology, we are doing a number of things, for example, we will be looking for resistance to tea parks which is really important, we are looking at immune corollaries. Those are things we are doing, the Clinical Trials that i mentioned are ongoing but theres a continuum from plea chemical to early clinical to advanced development. And those other questions we are still at the level for example when you screen for new drugs you develop assays looking at the replication cycle of the virus which fortunately for us, we have decades of experience with poxvirus is an be utilized that to develop vulnerable targets to use molecules that already exist to develop them or to develop brandnew molecules aimed at that. With regard to the financing, as we said many times i have had to move money from other areas to be able to address the questions i mentioned to you before. The money that we are using on the Clinical Trials is money we have taken from our poxvirus portfolio and others so we hope we get supplemental funding to do the things i am talking about. Another question please. Lets go to politico. One followup question for doctor fauci regarding what you just said. That is twice i heard the administration mention resistance to tea parks, is this a theoretical concern or something there is evidence of happening . Second question, i understand second doses are up in the latest vaccination but first doses are dramatically down. I am wondering if you have any on the ground feedback about why that is happening, from community workers, is there a feeling as cases go down people dont feel the urgency is gone . Is there concern . Those are my questions. Lets start with cdc and doctor walensky. This happens when we rolled out other vaccines, the initial people who rolled up their sleeves are really anxious to get this and we see off of interest in vaccines where as doctor daskalakis said we are accustomed to doing the outreach. We were learned lessons during covid and we are taking those Lessons Learned and doing the hard work of Community Outreach, we have seen successes through doing so in these large equity events and gay pride events and now we continue to do hard work to reach the smaller message as well. With regard to the first question about resistance whenever you have a viral illness that spreads with replication largely in the community and have a single drug you are using theres always the theoretical possibility of resistance and that is the reason we are uncomfortable when you only have a single drug shown to have efficacy or your proving it has efficacy which is part of the Clinical Trial. That is the reason we are putting in effort on looking at other targets in the replication cycle. Let me see if doctor daskalakis has anything to add. Just one thing. The recent announcement from cdc about flex ability and using hiv resources to address monkeypox is an important lesson. Monkeypox is not a disease we are working with an isolation. As we do the important hiv work it is funding with monkeypox so this is all part of the strategy to make sure we are able to reach deeper in the Community Whether it is large equity or smaller equity interventions for using infrastructure with demonstrated effectiveness to reach people all of that is in the mix to make sure we have education to people in vaccines in peoples arms. If i might just add our local jurisdictions received no resources specific for monkeypox. Not only have we moved those resources around but they have been stretched pretty thin with resources that have been available to them to address this outbreak and so kudos to them for all they have been able to do and achieve on limited resources and speaks to the need of supplemental funds. With that i want to end with summarizing this administration has made tremendous progress toward the fight against monkeypox and every tool to do that. Thank you for your questions and have a good day. Cspan is your unfiltered view of government funded by these Television Companies and more including media,. The world changed in an incident. Media. Com was ready and we never slowed down. Schools and businesses went virtual and we powered a new reality because at media we are built to keep you ahead. Media. Com supports cspan as a Public Service along with other television providers, getting your front row seat to democracy. Visit cspan. Org campaign 2022, your website for all our Midterm Election coverage on demand when you miss it live as will a statebystate maps and charts to track results from every primary. Cspans campaign 2022 your unfiltered view of politics. The Senate BankingCommittee Heard testimony from financial policy professionals about predatory banking practices, including student loan services. Among the topics discussed were buy now pay later products and the perceived benefits of earned wage access. [inaudible conversations] [inaudible conversations]