Distribute a vaccine. This is 30 minutes. All yours. All mine . Great. Good afternoon. And thank you, secretary azar, for joining us today at cdc headquarters. It is a privilege to have you with us and we appreciate your leadership throughout this unprecedented response. Covid19 is the most significant Public Health challenge our country has faced in more than a century. And the pandemic is not over. And the pandemic is not over. Earlier this week, covid virus cases reached over 40 million globally. Here in the United States, we are approaching a critical phase. In a few moments, dr. Jay butler, cdc director for Infectious Disease and the former Incident Manager of the cdcs covid19 response will provide you a brief update on our current situation. I know it has been a difficult year for americans, but we are going to come through this on the other side. I am also optimistic that we will have a limited supply of one or more covid Vaccines Available for distribution before the end of this year, but were not quite there yet. That is why it is so important that all of us remain diligent in our efforts to defeat this virus and to protect ourselves, our families, and our communities. At cdc, science, data, and service have driven our response to the covid19 pandemic, and our mission is to protect the health of every american and stabilize. American and save lives. Personally, i am incredibly proud of the men and women of the cdc. It has been an honor for me to lead them during these extraordinary times and to lead these extraordinary people. I would like now to introduce dr. Jay butler who will make remarks and then followed by secretary of health and Human Services alex azar and then we , will be happy to take your questions. Jay . Dr. Butler good afternoon, everybody. Thank you for being here. Fabulous to be able to speak to you today, and thank you for that introduction, dr. Redfield. We are here to give you the latest on whats going on with the covid19 pandemic. Unfortunately, we are seeing a distressing trend in the United States with covid19 cases increasing in nearly 75 of the country. To date, we have confirmed over 8. 1 million cases, and sadly, over 220,000 deaths since january. I know these are numbers, but these are also people, and we mourn these losses. In the past week, we have seen nearly 60,000 cases a day on average as well as several as 700 deaths. Here in georgia, we have also seen an increase in the number of cases despite the decline we experienced beginning in august. We are also seeing cases increase in really all parts of the country. In the midwest particularly, likely in part because people are moving indoors with the arrival of cooler temperatures. Another factor is that smaller and more intimate gatherings of family, friends, and neighbors may be driving infections especially as these gatherings move indoors and adherence to Face Coverings and social distancing may not be optimal. I recognize we are all getting tired of the impact covid19 has had on our lives. We get tired of wearing masks, but it continues to be important as it has ever been, and i would say more important than ever as we move into the fall season. It is incredibly important to continue these steps also as we look toward the upcoming holidays. We know that every activity that involves interacting with others has some degree of risk right now. There are four general rules of thumb for assessing risk and deciding how to best protect yourself and those you love. First, the more closely you interact with others. Second, the longer the interaction lasts. Third, if the interaction is indoors rather than outdoors. Fourth, interactions with the greatest number of people translates into the higher risks of covid19 spread. Understanding these risks and how to adapt different prevention measures can help you protect yourselves, your families, and your communities. We all want to live as safely as we can and minimize the risk of covid19 while it is circulating. Secretary azar will highlight what people can do to protect themselves. I went to spend a few minutes talking about an additional tool we will likely have very soon, the covid19 vaccine. As dr. Redfield mentioned, we are cautiously optimistic the vaccine will be available, although likely in limited quantities, before the end of 2020. Preparing for implementing is implementing a successful covid19 program is the crucial next step as part of our overall effort to protect americans, reduce the impact of the covid19 pandemic and continue to restore more normalcy to our lives and our country. The cdc is a proud part of operation warp speed, a partnership between the h. H. S. And the department of defense to develop, make and distribute millions of covid19 vaccine doses as quickly as possible while ensuring that they are safe and effective. In other words, we want to make sure they work. I am pleased to announce that all jurisdictions including georgia have submitted their initial Vaccine Program plans. These plans are an important milestone in our efforts to ensure successful delivery and administration of safe and effective covid19 vaccines so the ultimate goal is that everyone who wants to be immunized can be. Over the past month, cdc has provided Technical Assistance to each jurisdiction including daily checkins with staff, Weekly Conference calls with immunization and preparedness managers and in some cases, onsite assistance. My colleagues are currently conducting a thorough review of the draft plans and will be providing feedback to the jurisdiction during the next two weeks. It is important to recognize these plans are flexible because things may change as we learn more about which vaccines become available and what amounts and when. Additionally, each plan will include an executive summary that we plan to post online later this month allowing for maximum transparency and a general understanding of each jurisdictions approach. I want to highlight also the Pharmacy Partnership we announced last week with cvs and walgreens. Again, we anticipate that initially the vaccine will be available in a limited supply. When the supply of vaccine is limited, our efforts to vaccinate may need to focus on those who are at highest risk of severe disease as well as those critical to the response including those who provide care to the health care system. Inple at risk include those longterm care facilities such as those in independent living facilities. The Pharmacy Partnership for Longterm Care Program provides end to end management of the covid19 vaccination process, including getting vaccines to facilities, it provides for onsite vaccinations, and fulfillment of all reporting requirements. Longterm care facilities will have the option of partnering with cvs and walgreens, whose combined National Footprint will allow most facilities nationwide to opt into this program. Before i close, i want to remind you that tomorrow the vaccine , and related Products Committee is meeting to discuss the latest covid19 vaccine development. Next week, the Advisory Committee on immunization practices will be meeting. Meetings ofe independent committees will be broadcast live for the public, as well as the process that is being used to ensure americans have a safe and effective variety of covid19 vaccines. We know that stopping this pandemic is going to take all of our tools handwashing, masks, social distancing, and hopefully quite soon, vaccines. Taken together, these tools are our best chance of getting our communities, schools, and Health Systems back into normal operation. I would like to turn the podium over to alex azar, secretary azar, thank you for being here. Secretary azar thank you so much to dr. Butler and dr. Redfield and things, everybody at cdc for hosting us today. Thanks, everybody at cdc for hosting us today. It is an honor to express my gratitude to the incredibly Hardworking Team here at cdc for their efforts throughout this pandemic. While in atlanta i also had the , chance to learn about the heroic efforts of the staff and everybody at Grady Memorial Hospital as well as Emory University hospitals work on Clinical Trials for regenerons antibody cocktail and modernas candidate vaccine. Thanks to how we designed operation warp speed, if and when the fda gives the goahead for these therapeutic and vaccine products we will have , supplies already manufactured and ready for distribution. In conjunction with operation warp speed, the cdc, as dr. Butler mentioned, is leading the effort to coordinate Vaccine Distribution and Administration Working with 64 Public Health jurisdictions they partner with on vaccines each year. I want to offer a special thank you to every american who has volunteered for Clinical Trials, or help to raise awareness, especially among Diverse Communities where we need representation in our Clinical Trials. Anyone interested in signing up for a vaccine trial can visit coronavirus. Gov. And for therapeutic trials, go to riseabovecovid. Org. While we make this exciting progress on vaccines and therapeutics, we see concerning trends in many parts of the country, as dr. Butler explained. I am briefed with the latest ecdcacross the country by by cdcs experts each and every morning. There is hope on the way in the matter of safe and effective vaccines in a matter of weeks or months. But in the meantime, the bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe. Those are the three ws wash your hands, watch your distance, wear your Face Covering if you cant watch your distance, and avoid settings where you cant do those things. Thank you all for joining us today. Thank you to the American People for the incredible sacrifices you have made during this pandemic and thank you again to the dedicated team at the cdc we are happy to take questions. Yes. Reporter thank you, mr. Secretary. Last week, Emory Universitys dean of Public Health called your agencys undermining of the cdc and the President Trump unforgivable, and called the president s leadership antiscience. Dr. Butler was quoted saying he is deeply concerned the actions takegency was forced to would cost lives. Have you discussed any of that in your conversations today, since this was in the last week, and do you have any concerns about the allegations . Secretary azar i am not going to talk about internal discussions. I came down here to thank the incredible people at the cdc for their work. We talked about the most recent data around the efficacy and importance of wearing Face Coverings. We talked about the Vaccine Planning work around distribution of vaccines and i got an update on the incredible progress the cdc is making on increasing the data submissions from Nursing Homes and the National Health safety network. In terms of what you ask, let me be clear. The cdc is the premier epidemiological organization on the face of the planet. When we go to other countries, as i often did before the pandemic, they literally are named the blank centers for Disease Control and prevention, named after this very institution. This is the crown jewel of american and global Public Health. We revere it. But the cdc plays the role in what is a very unique, unprecedented pandemic. It has been 100 years since we have had a Public Health crisis of this type. This is bigger than h1n1. This is not sars or mers. This is something that impacts the entire government and the entire economy. The cdc plays an Important Role in that. But it plays a role in epidemiology. There are other key players. Even within my department there are agencies with important equity around Mental Health and opioid abuse around the pandemic. N. I. H. And fda, around research. And countermeasures. The veterans department, around care for our veterans. The Defense Department around force protection. Transportation around transportation issues. International commerce at the state department. International relations. The spread of disease globally. The cdc plays a vital role, but in a pandemic of this scope and size and it plays a role, not the role. I think some of the people who not having lived in or lead this organization during this type of a crisis, failing to appreciate that. Make no mistake, the cdc is an independent scienceled organization. We respect the science and their conclusions. What comes out of the cdc at the end of the day is dr. Redfields conclusions around science and evidence with the support of his team. That is how we operate and that is how we are going to keep operating. Yes. Reporter the cdc guidelines on [indiscernible] being within six feet of someone for a total of 15 minutes or more. It is reported there is an to shorten the isolation or quarantine time for schoolchildren [indiscernible] can you talk about that . Dr. Redfield sure, thank you very much for the question. Think to take the big picture, as we said before, the cdc is sciencebased and datadriven. As a consequence, as we get more data and understand the science of covid, we will continue to incorporate that in our recommendations. Originally, contact, as you know, that was considered to be high risk for potential exposure to covid was someone within six feet that was for more than 15 minutes. There is some recent data that has, that has been determined, the individual who had a series of shorter contacts, but over time, added up to more than 15 minutes, became infected. Clarifying that new science, that new data into our contact recommendation is what you are alluding to. Again, it is based on data that one did not have four months ago but it is data now that we have based on situations so we recorded it. The second part of your question, could you say it again for a second . Reporter efforts in quarantine. Dr. Redfield as you know, the data we have right now that is in play is that individuals that have had a highrisk exposure have a period of time after that when they actually become detectable for virus. Originally, the average was a little more than five days, then data showed it was a little more than seven days, and when you look at the data selectively, if you did the cut off at 14 days, you actually identified almost everyone that was positive. If you tried to shorten it to 10 days, we found that we missed around maybe 12 of people. Therefore, we stayed at the 14 days. All of those decisions were made without testing. Now there is a series of studies gathering data that are trying to determine, can you use testing during the quarantine to determine if you could shorten the quarantine from 14 days to 10 days or seven days . Again, it is datadriven. It is under evaluation. Obviously, we dont want to have people be quarantined for 14 days unnecessarily. So we are working hard to see if there is data now that we have testing that may allow us to be more confident that if we do testing at day five or day seven, we can use that information and more effectively understand so we can shorten quarantine. So it is not a policy, it is an area of research where we are gathering data right now. Reporter [indiscernible] dr. Redfield yes. Again, i have tried to say this many times but we are a sciencebased, data driven organization. We are not an opinion organization. If we get data, that supports a change in our recommendations, then those recommendations will change. Reporter there was a fairly new study out that said the number of covid19 deaths could be much higher compared to, i guess that would be a question for dr. Butler in previous years, i think we are up nearly 300,000 deaths. The cdc said two out of every three deaths is covidrelated. Could you talk about that . Dr. Butler sure. Dr. Butler the concept of excess deaths may sound cold but life is a sexually transmitted condition that is 100 fatal, so we know all of us are going to die eventually. There is an expected periodicity to that. There is the average life expectancy. We know that at any time, there is a certain amount of seasonal variation also, and this is something we have looked at for years in terms of the number of excess deaths caused during influenza season. Using that same methodology to look at what happened during the time of the covid pandemic is how we are able to come up with the fact that we know more people have died this year. We know some people are going to die no matter what. But comparing the total number to that expected number leads to a difference that ultimately leads to the 300,000 excess deaths you just mentioned. About two thirds of those we can link direct directly to covid19. What about the other one third . That is an important question to address as well. Some of those may be unrelated, perhaps because of limitations on access to medical care. Some of them may be unrecognized impacts of covid19. When we look at factors like Cardiovascular Deaths that arent directly linked to covid19, there is not a really great explanation for why we would see that increase in Cardiovascular Deaths. We know it is possible that covid19 could be playing a role in those deaths as well. Overall, i think it emphasizes the importance of prevention measures that we have been talking about. Reporter dr. Butler, you said that the vaccine could be available for distribution toward the end of the year. Does that mean, how widely and how long do you think it could be before a vaccine is available for widespread distribution to anyone who needs it . Could that be march or summer of 2021 . Dr. Butler sure. These are the questions that we are asking every day as we move forward with Vaccine Planning. As you are aware, theres a number of different products that are currently in critical Clinical Trial. There is a process to make sure those vaccines are safe and effective that we have to go through as well. A number of the Clinical Trials are ongoing and still in a fairly early stage. I wish we had a crystal ball we could look at. I wish i could say everything is going to go 100 according to plan. But we also know we have to be ready for if it doesnt. Looking at the current trend in the studies and the production of vaccines, it is reasonable to expect that we will have at least one or possibly two products available for the end of the calendar year. The next question is when. Again, no guarantees how much. That is also part of the iterative process as we continue to learn what the Production Capacity will be going forward. One of the beauties of operation warp speed is we are not waiting until we have all the studies completed and the reviews done before we start the production process. It may be that we find for instance that a vaccine is not effective and that is a vaccine that ultimately will not be administered to americans. Secretary azar and in terms of your question around the timelines on a lot of these, dr. Butler mentioned we have the moderna the pfizer and vaccines which are very close to his fully enrolled in Clinical Trials. When we get data out of those will be dependent on the trial. Thats outside of anyones control. We are as dr. Redfield mentioned currently Manufacturing Commercial Scale Production of all six vaccines we have investments or contracts with think losing including pfizer and moderna. We expect we will have by the end of this year enough vaccines to be able to vaccinate all of our vulnerable, the most vulnerable individuals. Then by the end of january, we expect to have enough to vaccinate all our seniors as well as Health Care Workers and first responders. Then by the end of march or early april, enough vaccines for all americans who want a vaccine. We have an overflow room because abiding by cdcs restrictions on the number of people in the room. Do we have anyone on the phone, a question from the phone that has been asked . Yes. Secretary azar we will try over to the phone now if somebody has a question. Do we have bloomberg on the phone . Please go ahead. Reporter this is emma with bloomberg. We were told by the leader of operation warp speed today that astrazeneca and Johnson Johnson trials will resume this week. Did you hear anymore about this as well as the nature of these safety concerns . Secretary azar you broke up a bit i believe the question status of thethe astrazeneca vaccine Clinical Trials. So as of now within the United States, unless something changed since i have been standing here, the astrazeneca trial remains on Clinical Trial hold in the United States because of the review by the fda of the company and the company as to a possible serious adverse event. What we do as a company as well as the fda, examine the data to determine when there is a serious event, is there a connection to the vaccine . Do we believe there is a causative connection . And if so, should the trial be restarted or continued or are there other precautions one should take tom maybe modifying the consent forms, anything about the protocol, thats part of that. The fda has been working to gather data and information from astrazeneca to assist in that evaluation. As far as the process, it is continuing as we speak and that will be a determination made by the fda. One more. Yes. Can we see who is on the phone . Who do we have on the phone . Fox. Do we have fox on the phone . Secretary azar, thank you for taking our questions today. The president of the United States has held numerous rallies around the country, many in the hottest of hot spots many with no social distancing and mask wearing. The president also says we are rounding the corner. In simple english, sir, are we rounding the corner and or these rallies a good idea . The second part, the president has been critical of dr. Fauci lately. What impact do you believe as this will have as your department tries to distribute and convince americans to take a vaccine that many surveys are showing some americans are skeptical about or concerned about taking . Our guidance is the same regardless of setting. Wash your hands, watch your distance, avoid settings where you cant do those things. Or anybody reconnected worst to school or work, going back to worship, or reconnecting to health or engaging in the political and civic life of our country, our advice remains the hands,hich is, wash your watch your distance, wear a Face Covering and avoid settings where you arent going to be able to do those things. That advice is the same regardless of any type of gathering. With regard to your second question, the president has assembled and has direct access to many different advisors, including the people on this stage as well as others. I try to make sure and from the beginning of this outbreak that the president is getting the best medical, scientific advice from a diverse range from the top doctors within this department. The president hears divergent viewpoints. He has made clear he has Great Respect for dr. Fauci. And as a close relationship with dr. Fauci, he said that in followup to those other comments. That should have no impact on the vaccine work that we do. The vaccine work we are doing, the American People should feel very reassured by the process established here. There are five independent checks around vaccine regulation. First, a vaccine Clinical Trial has prespecified endpoints. They are statistical and these Drug Companies have been transparent for the first time in history laying out what those statistical endpoints are. There is a totally independent data and safety monitoring board that will look at data that comes in, determine if those endpoints have been met. If and only if those endpoints revealedthat data gets to the company and the fda. Then the company will have its own second, independent process. It will have to meet their ethical standards for submission of an application for an emergency use authorization or biologic license. Thered, it will come to the fda, where the fda will evaluate the vaccine according to two sets of guidances, general vaccine guidance for covid and a second guidance for what it would require and expect in terms of approval. Then you have the fourth check, which is, as dr. Butler mentioned, the Advisory Committee at the fda, and asked her no that will be webcast, a public external advisory process will advise the fda. In the decision about whether to approve or authorize a vaccine will be made by fda career scientists. That is five independent checks. That combined with how this is working so far, look at the fact that we have three Clinical Trials that have been put on hold because of any type of safety concern. The system is working. This is being played by the book. One antibody trial has been put on hold. Two vaccine trials put on hold to ensure fda and we are putting Patient Safety at the center , following all regulatory ethical standards for development of those therapeutics and vaccines, all of those elements of process should reassure the american a vaccine orhen therapeutic comes out with the authorization or approval of fda, it represents career scientists best judgment that it meets their scientific, evidence, legal, and let and regulatory standards. Thank you all for coming today. Dr. Redfield and i have got to get to the airport but we appreciate your being here today and dr. Butler, we appreciate. Dr. Butler is the senior career official at cdc leading the coronavirus effort, and we are very grateful to him for his leadership. As we move into the future, i want to make sure, as you have had access, we want to make sure there are continued interactions and opportunities for you all to be continuing to engage with cdc as well as our career leaders here. Thank you very much. Goodbye. Cspans washington journal. Every day, we are taking your calls live on the air on the news of the day and we will discuss policy issues that impact you. Ons morning, scott hodge president ial candidates tax plans. Then senator bob casey examines the Upcoming Senate vote on judge Amy Coney Barretts confirmation to the supreme court. Watch washington journal live at 7 00 eastern this morning and be sure to watch washington journal saturday morning as we host the two leading thirdParty Candidates for president , the Green Party Candidate in than the libertarian Party Candidate jo jordgensen at 9 00 a. M. Eastern. The group new america looked at Voting Technology and the potential for voting by smart phone or computer in the future. This is just over an hour. Thanks for joining us today. My name is jane hu. Im a journalist and a journalist and contributor to future tense. Future tense is a collaboration between Arizona State university, new america, and slate that examines emerging technologies, public policy, and society. I will be monitoring our conversation, and i am pleased to be joined by kevin collier, a reporter at nbc news and larry norden, the director of the Election Reform Program at the Brennan Center for justice
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