Transcripts For CSPAN2 White House Holds Monkeypox Response

CSPAN2 White House Holds Monkeypox Response Briefing September 16, 2022

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 Health Community 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 wor

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