Microphones anytime you speak. During the any time hearing, the chairman the vice chairman of the committee, congressman kennedy will serve as chair until i am able to return. Beuments for the record can sent to Benjamin Tabor at the email address provided to staff. All documents will be entered into the record at the conclusion of the hearing. The chair will not recognize herself for an opening statement. Today the energy and Commerce Committee continues its oversight of the nations covid19 Pandemic Response. Examining the pursuit of a safe and effective covid19 vaccine that the American People can trust. In the eight months that we battled covid19, over 7 million americans have had the virus, and over 200,000 of them have lost their lives. Millions of the phase unemployment and have lost their Health Insurance, and families are still juggling childcare and virtual classrooms. The list of those most vulnerable to covid19s especially on the line as the virus continues to spread across the country. We know that a safe and effective and trusted covid19 vaccine will be a critical tool to stand this pandemic. I believe that i am joined by everybody in this hearing and everybody in this country and hoping that a vaccine is available as quickly as possible. This summer, we held a hearing with the leading Companies Working to develop a covid19 vaccine. The companies assured us that well the pace of the vaccine is unprecedented, safety and science are not going to be sacrificed for speed. Last month, these companies joined four other manufacturers in a rare joint pledge stating that they would stand with science and not put forward a vaccine until it had been thoroughly vetted. Our commitment will be critical as the future success of a covid 19 vaccine depends on the American Publics confidence that it will be safe and effective. Alarmingly, the public trust in a future vaccine has declined dramatically in just a few months. Nearly two thirds of americans worry political pressure will rush approval of a covid19 vaccine and more than half say even if it were free, they would not get vaccinated before election day. One does not have to search far to find the source of the publics distress. Time and again throughout the pandemic, at the Top Administration has politicized science, undermining its own Public Health experts get every turn, and, in fact, just last night and yesterdays president ial debate meltdown, President Trump called the process a very political thing. The white house and hhs leadership have interfered with cdc guidance and other scientific publications for political purpose. The white house has publicly pressured fda to issue emergency use authorization for prospective covid19 treatments despite objections from fda scientists. And the president unfortunately as attack the credibility of his own Public Health leaders. For example, just hours after cdc director redfield testified on the effectiveness of wearing face coverings at a vaccine, President Trump told the press the dr. Redfield was confused and had made a mistake. The president as politicized the pursuit of a covid19 vaccine repeatedly by claiming it will be available in october before a special date, obviously referring to election day, and he did that again last night. At the president as even accused his own fda of being part of the deep state, suggesting it was blocking a vaccine to hurt his political prospects. Following the reports the fda would be publishing additional standards for emergency use authorization of a vaccine, President Trump falsely claimed that the guide guidance was politically driven. The guidance was praised by external experts but it may not ever see the light of day because of the president s political whims. About thettee oversight subcommittee as been sounding the alarm on the administrations dangerous politicization of science for months, and frankly we are not alone in our concern. Sciencesnal academy of took the unusual step of issuing a statement warning that the repeated politicization of science undermines the credibility of Public Health agencies and the Public Confidence in them at a time when we need most. Fortunately, as we will hear from our witnesses, that there are ample reasons to be optimistic. The search for a covid19 vaccine is and will continue to be driven by science, and i believe there are steps we can take to restore the American Publics confidence. Namely, the Administration Must allow the career scientists at the fda to do their jobs free from political interference, such as allowing the time necessary to give a robust review of clinical findings. It must let fda release the additional standards for emergency use authorization of a covid19 vaccine once it is developed. All of us on this committee, democrats and republicans, are rooting for a safe, effective covid19 vaccine accessible to all americans, and we will continue our oversight until these goals are met. We will also continue to call for a comprehensive covid19 vaccine plane. I look forward to hearing from the panel today. Hopefully, our wonderful experts can help guide us on ways to help ensure that the public as full confidence in a covid19 vaccine once it is made available. I also hope that they can provide Additional Solutions and a suggested guard rails that will ensure science and not politics guides in the way, because the health of our nation depends on it. Now i am very pleased to recognize our Ranking Member for five minutes for the purpose of an opening statement. Thank you for holding this important hearing. It will be a vaccine that offers us the best chance to finally edit this pandemic, allowing our nation to fully reopen, but it is not just the vaccine itself. In addition to an approved or authorized vaccine, we will need widespread acceptance, distribution, and immunization to combat this virus. The purpose of this bipartisan hearing should be to increase Public Confidence in the food and Drug Administration edits processes for authorizing and approving vaccines through science based decisions that there is greatest Vaccine Acceptance and confidence among americans. Congress created the emergency and later expended that pathway and hazardemic reauthorization act on a bipartisan basis. Through those efforts, we provided special reporting to the fda to use in a Public Health emergency prior to full approval when the Scientific Evidence is available to support such use. To receive an emergency use authorization, a drug company must demonstrate based on the total totality of Scientific Evidence the drugs known or unknown potential benefits outweighed the potential risks. The fda can apply that standard appropriately to different settings, such as requiring more , rous standards the fda has announced it is approach. Ua plus through guidance setting stringent more stringent standards for other euas. I have great concerns and were trying to score political points by criticizing the fda in his vaccine review and approval process, particularly undermining trust in the fda authorization vaccine, especially during this Global Pandemic and international emergency. It is understandable that many in the public would be concerned and confused about the Vaccine Development and approval process work orders are being cut with unfounded witticisms circulating. The truth of the matter is that the review and approval stages of the vaccine will be controlled throughout the process but nonpolitical, independent scientific experts, not politicians. The data produced during the vaccine political trials are reviewed and evaluated by a isety monitoring board which composed of independent scientific experts. In addition, there are the fda vaccines and related Biologic Advisory Committee to propose leading experts expected to review the data. Even if congress has contributed to getting assurances on a scientific decision from the fda. It was this committees full Committee Hearing in june and other Committee Hearings over the past few months where congress and the American People received assurances from fda commissioner stephen hahn that he would support his career scientists, and the fda would not cut corners of dirt just over the safety and efficacy. The intense scrutiny is extended to other from highly respected Health Officials. Dr. Peter marx said he will resign his position if the fda or to greenlight an unproven vaccine. The director of the National Institutes of health and the director of National Institute of allergic and Infectious Diseases that they will only back a vaccine that is Science Behind it. Nine Drug Companies have already pledged they will not submit vaccine candidates for fda review until their safety and efficacy is shown in large Clinical Trials. In addition, each of the four companies now in phase three have published trial particles. , twoaccine distribution independent committees will provide guidance. The National Academy of science engineering and medicine and cdc Advisory Committee on immunization practices. I urge each of us to put politics aside. I know what are a few weeks from election, but put politics aside in order to deliver one unified thatsaving message americans can trust the fda vaccine approval process. They will be driven by the science and will result in science based decisions. Lastly, a reminder for everybody to get your flu shot this year will be more important than ever. I look forward to the testimony from these esteemed witnesses and welcome them to this hearing and i yelled back. Shotank you i got my flu too and i echo what you said. Everybody should get their flu shot. We will now recognize the chairman of the subcommittee for five minutes. Thank you. To date we will hear from some of the nations leading Public Health experts about one tool that will help put an end to the pandemic and suffering, and that is a safe and effective and trusted covid19 vaccine. I am pleased that you are all with us so that expertise and science have the rightful place in these discussions. We all want a covid19 vaccine to be developed as soon as possible. First and foremost we must confirm it is safe and effective and trusted and accessible to all who need it. ,s i said in our july hearing my fear is that the Trump Administration might force in the fda to approve a vaccine before proven to be safe and effective in an effort to boost the president s political fortunes. I hope that does not have and im grateful career fda officials have repeatedly stated the importance of putting signs first. Since january, the president as consistently placed politics over science eddie is undermined the independence and integrity of our scientific agents and experts. His words it created confusion amongst the American People, and so it is Little Wonder that pulling noshows public trust in the future covid19 vaccine has declined drastically over the past few months. That is why we have to build back the confidence of the American People as it works to ensure a safe and effective vaccine is developed. We will probably vote on an updated heroes act introduced yesterday. Included in that is 1 billion in funding for an evidencebased Public Awareness campaign to outline the importance of vaccines and combat misinformation, some of which is unfortunately coming from the president. , updated heroes act, there is also 20 billion added to authorize the secretary to provide grants or contracts for vaccine and therapeutic development, 7 billion to conduct activities to enhance, expand, and improve Vaccine Distribution and administration and language to provide grants to state and local Public Health departments for procurement of vaccines. I would also remind everyone the heroes act, as well this updated act, provides free treatment, drugs, and vaccines with no copays, similar policy we had and cares for testing and Contact Tracing with a free testing, in this case free vaccines and no copay. I regret that Mitch Mcconnell and President Trump have really stood in the way of the heroes act that the house passed back in may and i continued to call on Mitch Mcconnell and the president to come to the table maybe before we leave this week we will have a consensus, a bill to follow up act. E cares act it what we continue to see from this administration is political calculation and not science guiding its decision. Now of course the Trump Administration is attacking a potential Covid Vaccine in court because they want to strike out the Affordable Care act and they have asked the Supreme Court to do that. The aca requires that Health Insurance plans cover all recommended vaccines. If it is struck down, we will lose access to health care, including a potential vaccine for those who lose their coverage under the aca. At that to me is an outrage. I look forward to hearing from the witnesses today. I think the Trump Administrations actions would hamper the developments to effectively administer a vaccine. For that reason, i hope our witnesses can [indiscernible] i what guardrails they hope to see employees to keep that from happening. That is one of the reasons i want to hear from you to make sure we can prevent a situation where we have a safe and effective vaccine, we do not people do not want to take it. Thank you again, and i yelled back. Recognizes the Ranking Member of the committee for five minutes. Thank you, and i appreciate you having this hearing. American should have confidence that any vaccine approved or authorized by the fda will have gone through the most rigorous, independent, and transparent trials, testing, and review in the world. The scientific and public Attention Focus on the vaccine process is itself unprecedented. Fda has issued rigorous guidance for these vaccines and each of the phase three trials is enrolling at least 30,000 participants. The fda as multiple existing safeguards in place to ensure an science based decisions. These include standards for the vaccine review process, the emergency is authorization process and necessary evidence required to receive an approval that meets fdas Gold Standards. There are multiple safeguards outside of the fda. Each of the three trials will be overseen by the data safety and monitoring board. That is an independent Multidisciplinary Group which includes individuals experience ,ith Clinical Trials biostatisticians, bioethicists, the facts, and a biologist virologist. And the integrity of the data. In addition, all four companies in phase three trials published their Clinical Trial protocols to provide even more transparency. Independento experts who serve on fda Advisory Committee will scrutinize safety and efficacy data of the vaccine candidate. The evidence requires these vaccines to be consistent with the fda Gold Standard that made the vaccine supply in the u. S. Reliable, safe, and effective. Separately, the u. S. Centers for Disease Control and prevention, the cdc, the adviser reported is comprised of medical Health Experts responsible for developing recommendations on the use of fda approved vaccines for americans, including how, when, and to whom a vaccine should be given. It is incredible that a lifesaving vaccine gets to those most at risk for this deadly virus without delay once the fda independent scientists have glittered for safety and for efficacy. Indicateds now have that they plan to withhold distribution of vaccines while they conduct their own unprecedented review of the data. I think that potentially risk the lives of their own citizens. It would be the first time some of these governors have done that. Such reckless actions dangerously undermine the fda and leave a greater Vaccine Hesitancy and delay and describes distribution. They create public confusion with misleading information without vaccine safety and efficacy, and worst of all, it will jeopardize american lives. These dates have not provided any evidence or any expertise to conduct such a review nor have they cited any Legal Authority to prevent their citizens from accessing a vaccine approved by the fda, especially during the next Public Health emergency. The Scientific Collaboration throughout the covid19 research and develop an effort is extraordinary. That collaboration must continue through the complex Vaccine Distribution process, including deep privatization for distribution and all of the logistics involved in determining an approved or authorized vaccine. American scientists are making remarkable process progress toward a vaccine. Experts such as dr. Fauci are optimistic these efforts will lead to a lifesaving vaccine and will benefit Public Health in our country and around the world. It is essential all of us involved in Public Policy stick to the facts and not falsely denigrate scientists and Public Health officials working around the clock to save lives. Madam chair, in addition i would like to ask unanimous consent request to submit documents for the record. The energy and Commerce Committee republicans and worked over the last several months to develop recommendations to address scientists and regulators, in particular the expert staff of the fda. They set the global Gold Standard on the safety and effectiveness, and has unparalleled experience and vaccines in regulating are you safely and effectively by hundreds and millions of americans. Haveexperienced it first just firsthand experience of the fda, particularly in responding to Public Health emergency. Are i appreciate this bath the staff commitment to the public that these processes are followed. Covid vaccines are part of a welldeveloped system of independent checks that have been put in place over decades to build a reliable and robust infrastructure for assuring vaccine safety and effectiveness. There is great urgency and effectiveness. Time as fda commissioner we worked on a bipartisan basis with this committee to enact fdas authority for emergency use authorization which has since been used and augmented based on experience with the h1n1. The administration deserves credit for a work of operation warp speed, which has led to extraordinary progress in advancing multiple promising vaccines and a long and in certain sequential of element process to a much shorter parallel process, including conducting Clinical Trials at scale at the same time as scaling up manufacturing. The assurance and clinical Safety Effectiveness is imperative. Including emergency use authorization. The fda has provided researchers with early and frequent guidance in the process, including written guidance documents for Preclinical Development as well as safe manufacturing practices. Planslies that the fdas creates written guidance on the expectations for a vaccine is unnecessarily raising the bar. That is not the case. Fda standards are based on these decades of experience, and with the experience and development Public Healthing emergency. The fda has been sharing Regulatory Guidance with manufacturers and researchers, have the guidance is reflected on the combat of the largescale Clinical Trial and other Development Activities underway now. Vaccine manufacturers are committed to following the fdas guidance. Public statements as recently as yesterday that the emergency use authorization use are different and much higher than those with therapeutic products already on the market, like plasma, and they are same for the safety and effectiveness of other vaccines. Fda has required large Clinical Trials. Produceuiring them to large safety databases to monitor side effects that extend past a month or two during which most side effects occur. Use theintends to emergency use authorization to require substantial postmark and Data Collection and also augment evidence available on the vaccine. Congress designed the emergency authorization process to provide fda with the flexibility of the standards appropriate for the different concepts that arrive during the pandemic. All of these systems are vaccines facing effectiveness and are hard to disrupt and have kept the covid Vaccine Development process robust and on track. Range ofith a political accidents, including proposed actions by some andrnments to set up new untested vaccines. Despite the fact that Vaccine Development continues to follow fdas longheld standard in guidance. Concern is understandable, these political Actions Create uncertainty for the public that diminishes confidence in the fda in Vaccine Development. Over the years the committee has provided strong bipartisan support and resources for an effective fda for products on the medical need. We need that more than ever to avoid ending a prolonged pandemic and all of its health and economic consequences. And anything to put in the longer remainder, i appreciate it. I am pleased to recognize dr. Khan for five minutes. Morning. I am a physician, infectious asease epidemiologist and dean at the rate at the university of nebraska medical center. There was responsibility for national preparedness. We are currently witnessing the greater Public Health failure in our nations history. And shortsighted government response combined with the disregard for scientific expertise that has undermined trust and Public Health. Here today too be discuss my experience with preparedness planning and to reinforce that we must keep the Lesson Learned from prior vaccination campaigns, such as the 2009 h1n1 pandemic, including addressing the challenges we trust. Witho want to remind that 750 preventable deaths occurring every day in the United States, we cannot wait for a vaccine to contain this covid19 pandemic. While the preliminary data is hopeful, the prediction of an election day 19 vaccine has raised numerous concerns for the scientific and Vaccine Development community. As well as among the public for trust of the vaccine. Asst of the vaccine will be important, if not, more so of the safety and efficacy, which are easier to manage. The lessons of the 2000 9h1n1 may be helpful as it undertakes this vaccine. That response on communications and policy challenges across the federal Government Regarding the distribution of vaccines. The h1n1 vaccine was initially available in the United States in october of 2009, about four month after the who declared a pandemic. But the vaccine did not become more broadly available until december of 2009. By that time the peak of an 181 had passed and many individuals were not interested in getting vaccinated. This diminished the credibility at all levels of government at the amount of vaccine available to the public did not meet expectations set by the government. State leaders had poorly defined initial target groups of vaccination with unexplained variations between entities. And despite outreach efforts and provision of free vaccine, difference persisted between blacks and whites and vaccination rates. And logistics challenges included 100 dose minimum orders and many states were forced to thek down and repackage vaccine to serve smaller vaccination sites. There are a myriad of strategic withperational challenges potential covid19 vaccine, including the probable need for two doses of the same vaccine given 21 to 28 days apart. Multidose vials and others. It will be really critical to leverage our nations existing Public Health of them and Vaccine Distribution infrastructure to ensure the efficient effective antics portable access to these vaccines. Planning and priority setting up a state, local, tribal and territorial level is a must. We need to explore the interoperability and timeliness of the numerous data systems to manage and evaluate the effectiveness of the distribution and administration of the vaccine and manage and monitor the adverse event. While vaccine demand will likely be the immediate issue for any potential license vaccine, we must acknowledge the publics acceptance of the covid19 vaccine is not a given. There is evidence for hesitancy, even before any rare potential complications identified in post licensing monitoring. To increase vaccine uptake we must avoid the use of predictions and provide clear consistent and factbased messages. Lessons learned from h1n1 reinforce we need to underpromise and over deliver. Is noclusion, there guarantee that a vaccine efficacy in Vaccine Coverage will be sufficient to contain the covid19 pandemic. Right now, while we wait for the vaccine, we have the ability to implement an evidencebased play but will reduce the number of cases and deaths. This requires unified local state and federal leadership that is evidencebased and uses metrics. Thank you. I am ready to answer any questions. And if you may include my longer testimony in the record. You are now recognized for five minutes. Like to think the energy and Commerce Committee for allowing me to be part of this hearing. Inm an attending physician the provision of Infectious Diseases at the Childrens Hospital of philadelphia and a professor of pediatrics at the university of pennsylvania. The also the coinventor of vaccine that was recommended by the cdc used in the United States in 2006. And by the World Health Organization in 2013. I have been a member of the Advisory Committee immunization practice. I am currently a member of the fdas vaccine Advisory Committee as well as the active group assembled by dr. Francis collins to facilitate the development of covid19 vaccine. Is skittish public about the speed with which a vaccines to prevent covid19 are being developed. And its understandable. The language to rounding the effort is a little frightening. The rates for a vaccine and vaccine finalists have caused some to wonder whether critical phase is a Vaccine Development are being skipped, or worse, safety guidelines are being ignored. The administrations science like mask, hygiene and social distancing, and pushing drugs like hydroxychloroquine or plasma, without clear evidence of safety, have caused some to wonder whether the same standards will be applied to covid19 vaccines. Recent polls have shown that more than half of all americans will choose not to receive a covid19 vaccine if offered, which would make it difficult to achieve herd immunity and gain control of the pandemic. Despite these understandable concerns, im optimistic that what happened with hydroxychloroquine will not be repeated for vaccines for several reasons. First, the data safety monitoring board set or supervising covid19 vaccines have been charged by the group, withholding them to the same standards of safety that would be found for any vaccine. Which makes sense, given that most of those who will receive the vaccines will be healthy young people unlikely to die from this infection. The fda commissioner stated in a recent oped in a journal for the medical association that he would rely on transparent discussions by the fdas Committee Prior to authorization for licensure. Of committee is composed researchers who are not associated by the industry or government, and can be counted on to give an unvarnished appraisal of covid19 vaccines prior to approval. All the development of covid19 faster than been any vaccine ever produced, one aspect of that Development Prospect is identical to the way vaccines have been developed the past 70 years. Specifically the phase three trials. Phase 3 calls for covid19 vaccines with the placebocontrolled trials of 30,000 people. The science of these trials is typical. Human papilloma virus vaccine trial included 30,000 participants. Wasthe other vaccine 35,000. As long as these phase three trials are allowed to proceed until there is clear as typical evidence that the vaccines work and are safe on the groups who receive them, then they will be held to the same standards as previous vaccines. During my service on fda vaccine Advisory Committee i have come to know the people at the fda involved in vaccine licensor. People are exactly who you would want them to be. Dedicated to protecting the or effective. E if covid19 vaccines are released before they are ready, you will hear from these people fauci,ple like tony doctors trusted by the American Public and many academic researchers. The public is already nervous about these vaccines. If trusted Health Officials decry premature release, the celebration by the administration will be shortlived. Arepeople who understandably nervous about soontobe released covid19 vaccines, i think they can take comfort in the fact that many people in supervisory positions, as well as independent academic scientist ending behind them, im monitoring the process and looking out for the publics best interest. Thank you. Thank you, doctor. Dale for azing dr. Fiveminute statement. Morning tou and good chair, the Ranking Members and members of the subcommittee. Thank you for having this and for advice inviting me and my other panelists. I am testifying today and my capacity as the cochair of the committee on at goodwill of the vaccine for the novel coronavirus. In publicnt 30 years health than 20 years with the centers for Disease Control. In july, the nih and the cdc asked the National Academies to develop an overarching framework for covid19 Vaccine Allocation to assist policymakers and form the work of National Health authorities and other advisories in the development of national and local guidelines. On september 1, our committee release a graph of that framework to be able to get input for the public. The discussion presented Lessons Learned from other allocation efforts. And how this framework might be applied in various scenarios. Our final report will be released to the public this friday. Today i will be talking only about that discussion graph. Mentioned previously, this is not the first time the nation has faced allocating scarce resources during a Public Health emergency. Draft framework of hercine allocations previous efforts for vaccines that fourth and allocation framework that were being developed in the United States and around the world. Our Committee Proposed six foundational proposals that informed our deliberations about allocations. First we focus on the principle of maximization of benefits. That led us to adapt an overarching framework of overarching goals of maximizing societal benefits through the reduction of morbidity and mortality caused by the transmission of the novel coronavirus. Second, the higher rates with covid19 infections and serious disease and death among people of color link to the longstanding systemic racism and an equity, let us to a principle of mitigation that has helped in equity. Directsd principle attention to the equal work and value of every person. Principle of fairness highlighted the importance of impartiality, principle of transparency and providing open disclosure of the principles criteria and groups that determine our allocation framework and who would get the vaccine sooner than others. A final principle is that all decisions must be evidence base. To determine the Population Groups that comprise each allegation phase allocation phase, it characterizes Population Groups by the risk base by their typical members in each of these groups. Theddick or he category includes the risk of transmitting infection, the risk of morbidity and mortality and negative survival impact. Our Committee Proposed a four phase approached to allocation. Within the Population Group included in each of these four phase is, our Committee Recommended that the vaccine should be prioritized by geographic areas identified as vulnerable through cdcs social vulnerability index. We have four phases. The first includes a just start phase. That included Frontline Health , not defined by professional titles, but the risk of exposure. It also included first responders. The jump start phase is followed by a phase one d, which includes older adults living in andregant settings individuals with high risk underlying conditions that were also included in this phase. The second phase was an expansion of that supply would allow for immunization of additional individuals with underlying conditions that put them at increased risk. All older adults not identified as the first age, and also teachers and school staff. People who are incarcerated, detained, or living in group homes or homeless shelters or other congregate settings. And additionally, the first group of critical workers who are in industries essential to the function of society at high risk of exposure. All those are included in the second phase. Vaccines phase, when are supplied will become more widely available and allow for broader immunization of workers who were important to restoring the full Economic Activities and brought immunization as young adults. Finally, once vaccine supply became more broadly available, phase for vaccines would become available to any of those not part of the first three phases. While uncertainty about the Covid Vaccine existed, our committee approached our graph framework with the best Available Evidence understanding that this would continue to evolve. You that, i want to thank for the opportunity to testify. This is only a brief summary of our discussion graph. The complete and final report will be released this friday, willer 10, and that report an addition to having our final allocation framework, and discuss topics related to immunization, Community Engagement, acceptance and global consideration. Thank you and i am happy to answer questions. We look forward to seeing your report on friday. We now recognize you for five minutes for an opening statement. You. Ank it is my honor to be with you here today. We are nine months into the worst pandemic in a century. More than one Million People around the world in more than 200,000 americans have succumbed to this. While we have identified the series of Public Health measures if usedapies that, effectively, can keep the disease at bay, in order to bring the pandemic under control, we will need safe and effective vaccines. While it usually takes years and often decades to build a vaccine, unprecedented collaboration among the Global Scientific Community needs we have multiple candidates in phase three trials just nine months after we identified the virus. This is incredible. Here is the problem. While the process so far has been carried out with great scientific integrity, as we near the end zone, we need to ensure we do not fumbled the ball. Inhave seen large declines americans willingness to get a vaccine. And if we fumbled the ball, the cost to our lives and to our treasures will be enormous. Has been stated, here is the key point. We need to have vaccines that are safe and effective, and perceived to be so by the American People. So why are americans worried . They are worried because of the politicization of the federal agencies like the fda. Emergency use the authorization of hydroxychloroquine, or the unfortunate hyping of convalescent plasma, physicians and nurses and the American People increasingly worry about the integrity of the fda Decision Making process. The decision to issue an eua for a vaccine must be based on scientific constable, not on a political one. And the unease has grown recently as the pfizer ceo has moving to get their vaccine out before the election. This, on top of the landscape of local science than buying ativax theres, has created dangerous situation that could cause loss of safe vaccines for years. We must not let this happen. I believe there are three things we must do. First, we must let scientific standards drive whether a vaccine is safe or not. Fda scientist provide guidance about the requisite followup time period of the disease under severity. These are right and are at a minimum. We must ensure that we let fda use their standards for approval. We need a lot more transparency in the process. Heartened to see Vaccine Companies make their protocols public, we need more transparency about safety signals and their trial and how they are addressing them. Unprecedented times like these come for unprecedented transparency. It is critical that when an directly fromear the scientists at the agency. This will assure the American People that science is driving this process, not politics. These are critical steps and they alone will not be enough. We need a strong communication plan that engages the critical and Public Health leaders, religious leaders and others about the process. Americans will turn to these individuals to get advice. We need a plan for fair distribution. This is a source of immense concern for Many Americans. We cannot repeat the mistakes we are making with testing, where the wellconnected can get tested on a regular basis, but regular testing is not available for school teachers, nurses and first responders. We need to ensure vaccines are available for all of us, not just those of us who are wellconnected. We need to eliminate all financial barriers to getting vaccinated. One in three americans say they will miss the vaccine because of financial concerns. We cannot let this be the case. 2020 has been a hard year for all of us. 2020 one can be better. Get some semblance of a new normal, we need a vast majority of americans did the vaccinated. Americans to be vaccinated. Withaccine has been done great scientific credibility. Its time to let science finish the job. Its use science to indication to let people understand the process. Lets eliminate financial barriers and introduce a plan to ensure we can turn vaccines into vaccinations. If we do all of that, we can bring the pandemic under control, heal our economy and let americans get back to their role. Ourhank you to all of panelists for your excellent testimony. Now it is time for the members to ask questions and the chair will recognize for five minutes. When i was watching the debate last night, i suddenly realized that the president , who has been politicizing this vaccine approval process is actually trying to blame the democrats for that. I dont do get should be politicized by anybody. All of our panelists today testified that we need to rely on the scientific integrity of and scientists. I believe strongly in that and i believe that is what we need to do. That is the impetus for my questioning because i think that the career scientists have been systematically undermined for months. With both thought hydroxychloroquine, emergency use authorization approval and then of course the plasma emergencies approval. I want to ask and what i have been asking all of the efforts when i talk to them experts when i talk to them, i keep hearing about these guardrails pressuret the undue that is put on the agencies by the president for these other euas to be used in a vaccine approval. And what i hear from everybody is we have these guardrails. In your testimony, you talked about several different guardrails, the data safety monitoring board, the fdas vrbpac, and other systems for review and approval that you review. Nig, the wonderful fda and scientists nih scientists. Do you think these will be sufficient to prevent undue pressure from coming onto the agency, even the process and simple ordering of approval by this president and the administration . Yes. There is a third thing. Willdvisory agreement independently review data and independently make a decision about how its recommended. I, like you and worried about science. But it do think hydroxychloroquine me stop you let because i want to ask be other panelists. The you feel confident in the guard rails put in place for the vaccine . I do. Rep. Degette what do you think, dr. Mcclellan, do you think they are sufficient to stop undue politicization . Mcclellan i do. Not just me, yesterday seven former fda commissioners all said the same thing. This is a very robust process. More concerned about is the impact of political influence on confluence. Rep. Degette that is why we are having this hearing today. I believe there was an article in the Washington Post this morning about that statement. And its titled seven former fda commissioners, the Trump Administration is undermining the credibility of the fda. At the end of a hearing i will ask you about the article in the record. What about our other witnesses . Do you think we have sufficient guardrails in place to stop undue politicization in this process . Khan i think the guardrails are excellent. I think the guardrails are excellent but winning to remember they have not worked so far where we have worked at c looked at cdc guidance. We have asymptomatic individuals. Whether the guidance for children in schools. There is a number of guidelines from the cdc that has not been subject to those guardrails. Rep. Degette what do you think we can do to ensure those protocols are followed, very briefly . Cdc, we need to ensure the same set of guidelines for the Public Health in general. Im not sure the public to frenchy aids in terms differentiates in terms of science. Rep. Degette do you think the guard rails that were outlined are sufficient . The guardrails are strong. I completely agree with all of my fellow panel members. The problem is some of the signaling for instance, the about the been public Advisory Committee. Its true but unhelpful and we know that he has succumb under pressure. Reassuring. For i would bike much greater clarity that the fine just will get to drive this process. Wonthe fda chief override the Advisory Committees recommendation. As long as i happens, i will feel more comfortable with the guardrails. Think everybody agrees that we need to make that all ofments the scientific principles will be followed and the this will be a rigorous review. Congressman guthrie, i recognize you for five minutes. Guthrie i want to thank you for your testimony and what you just said a few minutes ago. You will have a lot of confidence in the fda, the scientists, the Advisory Committee, independent Monitoring Committee that has strong guardrails in place. Witnesses say they are in place, but they could go off rails. I am just concerned we are going to save things and not feel comfortable about vaccines. We had a vaccine on Vaccine Hesitancy. And its something that i think the scientists will scream and yell if Something Like that happens. We need to make sure people can have confidence with a safe and effective vaccine approved by the fda. Hopefully we can keep our rhetoric going in that direction. That point, i in would like to ask you, if vaccine manufacturers apply for emergency authorization prior to submitting a biologics license application, what kinds of Scientific Data will the companies have to provide to the fda about the safety and the performances of the vaccine . And how soon will those packages be submitted under the preapproval process . Did you get all of that . Dr. Mcclellan i think so. Representative, i had a chance to talk with dr. Peter mark or he reiterated that he expects the evidence for the vaccine approved to be very similar to that for a full approval. Full approval includes a lot of additional documentation. Thousands and thousands of pages, dealing with a lot of issues like, is the vaccine going to be stable on the shelf for the next six months . That is not the context we are concerned about here. Of this is notl only reviewed by the fda, as was said, there will be an Advisory Committee meeting for each vaccine that comes forward with an emergency use application. For the fda to write a written review for discussion and for independent advisers about whether the vaccine standards are being met. People have been doing this for tremendousave a amount of experience with vaccine safety, and quitting for vaccine use. And after that the fda will. Rite a written basis decision even before use, it will go to another independent review by the cdc immunization practices committee. Those are a lot of steps that people should be looking for in terms of transparency. An independent regulatory expertise, scientific expertise all with the right amount of evidence. Guthrie can you explain why the ea you for covid19 vaccine would be different than the ea you for a covid19 therapeutic customer their peter . Dr. Mcclellan its very different therapeutic . Its verylan different. It was to respond as needed in the Public Health emergency. Isyou mentioned earlier, it about the totality of the evidence in a particular context. Something likeof convalescent plasma, were the treatment has been around for 100 years and used in many different infections, its on the market now and may be used in thousands of sick Covid Patients with no significant evidence of safety side effects. We dont have the evidence on benefit, and that is where i think some of the Political Leadership got it wrong when they were characterizing what fda career staff decision was. They made it sound my get was a clear, beneficial treatment. What we are talking about is a treatment that is already being used for people that are hospitalized, that it shows is not harmful, and that kind of expanded access is something that fda has a tradition of doing for unmet medical needs in people who are very high risk. I hope we get a Clinical Trial done more comprehensively to answer the question. But it is a very, very different context than a new vaccine used in people who are not sick who are trying to keep well. Rep. Guthrie can youlain why explain what the fdas guidance is that gives you confidence for any decision made and any safeguards made outside of the fda . Dr. Mcclellan we have already covered that. There is a whole checklist we have already talked about. Writings will be coming from the is staff before a decision made. Make sure that happens and lets inform the public about that. As you pointed out earlier, all of the vaccine manufacturers said they are going to follow this process. Even though the fda written guidance has not been released, believe me, all the manufacturers know whats in it and yesterday they reiterated that publicly of what all was in it. We also have a lot of independent experts, other agencies. Its a very robust process developed over decades the cousin vaccines are so important. Because vaccines are so important. Rep. Guthrie i yield back. Rep. Degette we now recognize the chairman of the committee for five minutes. Thank you madam chair thank you, madam chair. With the Trump Administration adermining science, we have poll showing that majority of americans have reservations about getting a cold in once it becomes available. Are theyou believe consequences of this repeated subversion of science and attacks on the Public Health agencies . Dr. Khan thank you. There is no doubt that over the last eight months we have throughed science conversation of three or four. One is misinformation and manipulation of science. The second is elevation of personal liberty above our social responsibility. The third is equating Public Health signs with having enough hospital beds, than to laters and body bags. And forth would be probably discounting the value of life for 20,000 preventable 200,000 plus preventable deaths in america. There have been numerous documented evidence of manipulation of science. That, from aoubt public perspective, its easy to see why anything coming out of the administration could be mistrusted. Been a conversation that there is a lot of independent review of vaccines. At this politicization has undermined Public Health science in america. Rep. Pallone you have expressed your disappointment in the nations Pandemic Response. Can you you describe it as among the worst in the world here it has the Trump Administrations politicization of the science contributed to this . And what do you think the impact has been . Sorry, i was muted. First of all, there is no doubt. If you just look at the data and the numbers that dr. Fauci said last week and look at the numbers, we are among the worst performers in the world. Have the best Public Health scientific agencies in the world. Gold standards. Everybody else looks up to. We have not let them function in a way that we really need them to function. There is no question on anybody on this panel about the integrity and the capability of both of these agencies. The problem has been that their that their itses are overridden and unprecedented. It has never been done before under a republican or democratic administration. Made it much, much harder frost to get things under control and has led to a lot of people dying. Mentionedne you have that you join six other fda commissioners in this oped and Washington Post raising concerns over the Trump Administrations actions, not only undermining credibility, but you wrote in confidence. Themu believe it has left to do their jobs and that they could be trusted to let science guide their decisions, whether vaccines are new treatment . Dr. Mcclellan i do believe so. As we said in that oped, despite recent political actions, we continue to have positivity in the fda staff. Guidances writing a and this is a major process with a lot of Regulatory Oversight. All of the independent scientific engagements from , includingdies enrolling and conducting very large Clinical Trials on multiple companies. Justis not an easy process because somebody says something about it. It does undermine confidence. Rep. Pallone we have to fix this, right . What can we do to restore trust in the nations Pandemic Response . We have heard some of the things that were put in this new updated heroes bill. The experts and scientists are in place, what do we need to get the president and his cronies out of the way, or to fix this so we can go back to having the fda do its job . Think all political leaders need to stop talking about things like timelines. Politicians dont know what the scientific timeline is. Unfortunately, the political appointees have not been helpful. , if theave said is career scientists are the fda and the cdc get to do their job and we hear from them directly, that they believe the process has high integrity. Enormouslyt would be helpful in go along way to offer assurances to the American People that this is a process of integrity. I we need a whole new set of independent bodies. Weve got independent bodies. The doctor is on, if that committee shows Scientific Evidence is strong and clear, i think the American People will feel assurance by that. Making sure that their words and voices carry the day and not the political leaders. Rep. Pallone thank you, madam chair. The chair is now pleased to recognize the Ranking Member of the committee. Good afternoon. Thank you, madam chair. Thank you to our witnesses for your fine testimony. Stateclellan, some officials are expressing skepticism about potential covid19 vaccines. Saying their states plan to conduct their own investigation before distributing a vaccine. Despite an approval or authorization from the fda, eu believe such reviews by a state would be necessary . Has it been done before . . Re they equipped to do this have they done this on anything else fda approved . Slows down access to fda approved vaccines to save lives. Dr. Mcclellan i do have some concerns about it. We just talked about how expensive and how much resources go into the fdas process. The process that you all have supported for your implementation on a bipartisan basis of continued efforts to strengthen and improve the cosmetic act, which is meant to provide a highlevel of confidence, safety and effectiveness of medical products. And the future for the American People. With a huge undertaking lot of expertise, experience, culture. If a thiefto see body could add to that. I understand where the impulse is coming from. Duee if what the group was would do is just go through this kind of checklist. Its all the things we talked about. Are they actually happening. Is the process being followed . Maybe that could improve confidence, but its hard to see how to replicate anything like this national Gold Standard system that really developed. I would just say, i have been through a lot of closeddoor discussions with the hhs, with nih, dr. Fauci, dr. Redfield, they all say we are going to follow the standards, we are not going to yield in any way. It will all be about the size and the data. Are there other independent science review boards set up outside the fda to look at these things, to look at the data . It technically might be encompassed within the fda and cdc. But are they independent . There is not just the fda, but a whole system of Regulatory Oversight scientific expertise. How the data about safety monitoring board, which nih is generally involved in for the trials, nih expertise, cdc expertise, and cdc drying in a whole set of independent exports experts on immunization practices, which will also provide our review of part of this wellestablished process. Inis a system like no other the world. We are very lucky to have it in the United States. We are hearing internationally that russia has a vaccine they are ready to push , and china. Tell me how their systems work in contrast hours . Dr. Mcclellan contrast to ours. Their processor not anything like ours. These large trials has to prove and demonstrate that the vaccine reduces the number if infections , it reduces severe infections, it has very large databases, tens of thousands of people have been followed after they get the vaccine, it has the fda on top of that, it has additional monitoring on the people who are first to get the vaccine, the first responders, health professionals, and others who are at big risk to getting it because of the ongoing pandemic. Its a system that is really setting the standards for the world. Rep. Walden do you want to weigh in on these matters . I saw your head nodding like you want to add in. Dr. Khan i just want to add into dr. Mcclellans comments. In russia the vaccine has less than 100 people will have been vaccinated in a phase one and phase two trial. That is in possible in the United States. Agree there do you are independent organizations that are comprised of people with great integrity and scientific ability that will be pushed around . Absolutely. There is no doubt about the integrity of the people. There is no doubt about that. It is really an issue of confidence, and how do we assure that wednesday zack scenes are available, the checklist has been completely followed rep. Walden . Rep. Walden thank you to all witnesses. Madam chair, i yield back. Rep. Degette the chair recognizes congresswoman czajkowski for questioning. Czajkowski i as the Chicago Community trust. Welcome today. So glad that my congress and i have passed legislation to provide covid19 vaccines to most americans at no cost. But west extend must extend that protection to uninsured people. A vaccine can only be as effective as americans and people around the world who can afford to take it. But lets be honest about it. Just because people dont have to pay when they received the vaccine does not mean that a vaccine is free. U. S. Taxpayers have already paid Drug Companies over 10 billion for vaccine andarch and development that through operation warp speed. In the years to come, public plans like medicare, medicaid and the v. A. , etc. Will all be companies, ifdrug they are allowed to use monopolizing power to charge whatever they want. And lets be clear that if the republicans and the president of the United States had their way to and the Affordable Care act at the Supreme Court, and the prohibits cost sharing for Preventive Services and that would be eliminated. That means that all americans copays for all vaccines, including covid19 vaccines once the Public Health emergency is over. And finally i just want to say that a report was just issued that, wealthy nations represent just 13 of the worlds population have already bought over 50 of future covid19 vaccine doses. Ask twould like to questions. Ensure equitable access, do you believe the federal government should require pharmaceutical companies to sell a taxpayerfunded covid19 vaccine at a transparent, fair, and reasonable price . Let me start off saying its absolutely necessary for the u. S. Government. They have been a major investor in these efforts. Weatherman during a are companies moderna whether moderna and other companies a part of these vaccines. The big question is what is a fair price . What is a reasonable price . These vaccines are going to be needed by billions of people around the world. You dont need a large margin on every single vaccine. That absolutely essential the vaccine be affordable, be affordable to americans, american taxpayers and affordable to the rest of the world. Rep. Schakowsky i want to thank you for mentioning that in your opening statement. I appreciate you mentioning this. Costs being so important. That was my second question. If we can, we as americans can really be protected if other countries cannot afford the Covid Vaccine . I wonder if you would elaborate on that, especially given the research that was just announced. If your only goal is to protect the American People what say we did not care about other people in the world, but we as americans do. If our only goal was to protect the American People, we would want to make sure much of the world gets vaccinated. There would continue to be large outbreaks in other places and they would see their way here. Ody would be 100 at 10 protected. So there would still be vulnerable americans. Part of protecting america is making sure there is widespread vaccination all over the world. Rep. Schakowsky thank you. I yield back. Think thete i gentlelady. The chair recognizes mr. Mccamley for five minutes. Thank you, madam chairman. Last nights president ial debate truly was a debacle and embarrassment to the American People. But now, democrat leaders and the liberal media are expressing similar disrespect. The integrity of our Scientific Community by sowing the seeds of doubt about the efficacy of a safe vaccine and interjecting politics into this. Has since the virus, there been a rallying cry to get a vaccine as soon as possible. To his credit, President Trump instituted operation warp speed to do just that. Congress overwhelmingly voted to fund the program. But now, just as we are on the cusp of having a viable vaccine, and safe comment democratic leadership was to move the goalposts and slow down the process. Speed is still of the essence. , what part of operation warp speed dont they understand . Scientists dont give two hoots about who the president is or who controls the house of the senate. Using the same protocol they have been using for decades, the scientists want to create a vaccine so people can constantly return to work and schools. Their public has been clamoring for a vaccine. Now democrat leadership wants to perpetuate political conspiracy theories that only appears to the American Public more. Cant we just stop this foolishness and put aside our political grandstanding . The scientists, our career scientists, and the fda to do their job. My question is to dr. Mcclellan, do you think politics is motivating the democrat leadership to question the efficacy of a drug, even before it has finished Clinical Trials . Dr. Mcclellan there are certainly a lot of Politics Around this issue in the coronavirus response. About the value of operation warp speed for making the Vaccine Development and leadingfaster to the potential for actually having a vaccine by the end of the year, and maybe next year having a big impact on the pandemic and our health and our economic wellbeing. Rep. Mckinley if i can go back again. And thes of mistrust misinformation from the democratic leadership are alarming. Public trust, as you pointed out , public trust in the Covid Vaccine has dropped by nearly 30 in the last couple of months. Is it reasonable to assume that this mistrust of the Covid Vaccine has permeated into the mistrust of other vaccines that we need . Dr. Mcclellan it certainly is. Thats why this hearing, and i think the bipartisan support of this committee thats steadily provided for the scientific progress process is so important right now. I hope together you can all hope restore the confidence in the what i think is a very strong Vaccine Development and oversight process. Rep. Mckinley again, let me reinforce that you were saying earlier. You think the guard rails are in place to be able to provide this . And this is involving politics. I heard you say yes. Snt that a shame the guard rails are in place and we demonstrate that, the only reason this is being raised is because there is an election process coming up in five weeks. Comments . Dr. Mcclellan i would like to leave the politics out of this and i appreciate the bipartisan inerest on the committee making that happen, or helping to make that happen. Rep. Mckinley shame on people for making this partisan. This thing we should resolve. We have had the mission to try to keep to get the vaccine approved. I think all of the panel those this. This is politics. Unmitigated politics. I yield back the balance of my time. Chair nowte the recognizes representative kennedy for five minutes. Kennedy thank you, madam chair and thank you all for being here. Divers enrollment in that Clinical Trial has been a concern long before covid19. Systematic targeting without consent for Clinical Trials. There would be hesitancy in those communities to participate in Clinical Trials. Given the increasing data on the disproportionate impact of the covid19 color, it is more important than ever that we ensure our participation and Building Trust in the vaccine in those communities. There are concerns about companies that they are struggling to recruit black participants in the trials. Its upon them to try to right the wrongs of the past and engage communities and people who have historically been undervalued. I know you have been involved in numerous Clinical Trials. Provide Clinical Trials us with information about the safety and efficacy that i have mentioned . That is certainly the goal. One of the company showed up because they wanted to make sure they had adequate representation. One does expect you will have clinical differences based on general race or background. Regard people who are older who may not respond with certain vaccines. Think that is the goal if they are going to go to people and say, you need to get this vaccine, we have to be able to say you are being represented in the trials. All the things. I am 65 and i will not get any vaccine that has been done by anybody by my age group. The same industry true for ethnic or racial minorities. Rep. Kennedy thank you doctor. What are the consequences if we do not adequately have representation around a diverse range of participants . Which of the congress and government be doing to address that . Dr. Gayle thank you for that. Obviously this has been a pandemic that has disproportionately impacted people of color. Also mentioned, it is critical to have people of color in rolled in these trials so it can be confident that these trials have looked in populations that are it by the pandemic. While we have talked a lot about the guard rails within the thatal government system is clearly developed to have the overarching trust in the development of the vaccine, but it also means that partnerships ,eyond the federal government with trusted institutions, with communities, all of that needs to happen in order to build that confidence. And there is a lot that can be done to make these Clinical Trials much more accessible to communities of color. Where the trials are done, what doctors offices participate, what medical institutions are part of it. I i think there is a lot more that can be done to make sure the trials are made accessible to those who are being hit hardest by this pandemic. I saw you nodding among to her comments. I wanted to get your thoughts on this. Thank you for your incredible work and you are outspoken on some of these issues. Speak about some of the potential vexing confidence concerns among communities of color. Mistrust is not surprising given the long history of structural racism. Briefly, what more do you believe needs to be done to ensure that any future vexing will be safe, effective, and trusted vaccine will be safe, effective, and trusted . Thank you for being my representative. Yle said,on what dr. Gai it is absolutely critical that we engage political leaders, religious leaders. Having this presentation is the first step and thats going to require a lot. Even after that, building up confidence in communities of color is going to require engaging with leaders of those communities, trusted voices in those communities and working with them. They are not going to give you a pass unless they are confident that their communities have been well represented and that this is beneficial for them. I think there is a whole strategy here that is necessary. This is not a, we show up one day, knock on the door, and say we have a vaccine. We really have to take a proactive approach. There is a lot to build on and this does not have to start from scratch. Weknow about the leaders, know a lot about the institutions that are trusted in communities of color. We just need to build on some of those things and make it a priority and be intentional about it. Rep. Kennedy i had a brilliant question for you. Unfortunately, my time is up. I will yield back the negative time i have. Rep. Degette the chair now recognizes mr. Griffith for five minutes. Building on those questions, it, you have indicated to mr. Kennedy when he was asking questions that one company had slowed it down their process in order to get a diverse Demographic Group mix. Can you tell us who that company was . I thought it was interesting and i have not heard that. Astrazenecas phase three Clinical Trial was put on hold. The trials have resumed in the United Kingdom, brazil, and south africa. Excuse me. The trial isge, still paused in the United States. Would you agree that this action taken by the fda excuse me again signals a commitment to safety and not rushing the Clinical Trial process . I think first of all, the astrazeneca vaccine trial in the United Kingdom was put on clinical hold twice, one in july and a second time in september. When you do that, because there is so many investigators involved, that will always be known by the press and the public. You dont really know the details, because confidentiality precludes you from knowing those details. I have talked to the head of the board in the United Kingdom about this and he cannot give me the details. It is very frustrating because we think we know what those two cases work, but we dont. We know that the u. K. Regulators have now taken that clinical hold off because they presumably felt that this association was coincidental and not causal. , but that hasnt happened here. Thats part of the frustration and all this. , youact of the matter is cannot really be transparent about these cases because of confidentiality issues. Boston, youiving in are bound to have an accident, thats the way this is set up. Dr. Mcclellan just to add to that, i think it is also a reminder that this is a scientific process that is very much in process. The fda is right on top of this, watching closely. Before anyone gets brought access to this vaccine, there will be a public opportunity through that public advisory review to go through this and any other Public Safety issues that have come up during Clinical Trials and a chance for like paul, i know he wants the information now, but he will get a chance before there is any decision about this vaccine. This is how it goes with Vaccine Development. They need to be put in the context of the overall trial and all the rules and safeguards, including blinding and confidentiality. That will all happen before any decision on the vaccine. Let me shift gears, just because i see the clock ticking. There was an oped in the New York Times last week in which a doctors expressed concerns about Clinical Trials for the covid19 vaccine. Meet thesean benchmarks for success if it lowered the risk for mild covid19 but was never shown to reduce moderate or severe forms of the disease or the risk of hospitalization, admissions to the intensive care unit or death. To say that a vaccine works should mean that most people no longer run the risk of getting sick. That is not what these trials determine. Do you agree with these concerns . Either way, tell me why. Dr. Offit i dont agree. If you look at the Natural History of the people affected with sars cov 2, the first time they are infected, typically the second time they get a fact when they get a second infection, it is mild. I think they are exactly wrong. I think it is actually much harder to prevent asymptomatic infection or mildly symptomatic infection. If you are if you can prevent that, youre are much more likely to prevent moderate to severe disease. That is not really the history of modern Vaccine Development, so i think they are wrong. If i get it again, it will be mild . Dr. Offit thats what you want. What you want to see when you develop a vaccine is that that you are naturally protected. It is not usually the case where you are also prevented against having mild disease. If you look at the animal model studies, you can protect lower respiratory disease, pneumonia, but you dont really protect against shedding. I honestly think that oped piece was just wrong. I yield back, madam chair. My time is up. Ruiz . We have mr. Hes next in the order. Ok, oh, there he is. You are recognized for five minutes. Thank you so much. I really appreciate this hearing. It is so vital that people have the confidence in the science of the development of the vaccine. Continues tomic ravage our community, we have seen repeatedly that certain populations remain a high risk for contracting and dying from covid19. This includes highrisk essential workers, people of color and the elderly, and individuals with preexisting conditions. I know we all wish that there would be enough vaccines for isryone as soon as one identified, but that will not be the case. Some experts, like cdc director robert redfield, say it will be mid to late 2021 at the earliest before the u. S. Is widely immunized. Once the first vaccine is approved, things are going to move fast. Things that vaccine will be distributed immediately. So it is imperative that we finalize distribution plans now that prioritizes the most vulnerable or those at highest risk. The most vulnerable and those at highest risk mean those that are most likely at highest risk to get infected and at highest risk of dying from covid19. So, these vaccines cant adjust to go to the highest better. Publicto have that Health Approach to save as many lives and get through this pandemic as quickly as possible. You state that in your testimony, that while spread throughout the society, the pandemic more significantly harmed some populations more than others, particularly causing high rates of infection, serious illness, hospitalization, death to people of color due to systemic racism and in equity. So many oft i and my colleagues have been concerned with. Communities of color are not specified as priority populations. Furthermore, essential workers have been mentioned, but there is a difference between highrisk essential workers, people that work in the farm fields, grocery stores, versus low risk, younger, affluent people who can work from home and have their own room to work from and be physically distanced from everyone else. Recognizing that the final report will not be released until this friday, could you set some line as to how the Committee Considers and addresses these disproportional impacts of covid19 on black, latino, Indigenous People in this country . Is there any classification of the risks of essential workers, those that are at high risk, versus those that can selfisolate and work from home better at low risk and dont have any underlying illnesses . Dr. Gayle thank you very much. This framework was asked for by as thisand cdc so that moves rapidly, there was an overarching guideline for these allocations. As you mentioned, you know, one of our principles, as was mentioned in the report in my statement, was the mitigation of health inequities. We felt very strongly that we needed to latino, africanamerican, Indigenous People identified directly if they are not specifically mentioned. How are essential workers categorized as highrisk versus low risk . Report, youn our will see a lot of discussion. What we try to do was use the social vulnerability index, as well as the categories, including highrisk critical workers, as a way of getting at the issues. Because its not because you are black or brown that you are at risk, it is because of the social economic historic impact on health as a result of racism and inequity. What we really try to do in our tiers, and are phases, was to address those issues. Socialusing the vulnerability index, which is an index that looks like looks at minority status, household crowding, other issues that put people at risk, as a guide across all of the other different phases. You should prioritize the geographic areas recommendations to have transparency and measure if these principles are being followed . Our role at the National Academies to do these studies. We did these at the request of nih and cdc. We expected that they will look at these recommendations. So, i would suggest that the recommendation, as any Public Health expert would say, and i am one of those Public Health experts, graduating from the school of Public Health at harvard, that recommendations on evaluation, transparency, metrics in order for the community to see if systems are being followed is important, because the Current System have left out these communities and rendered them highrisk of getting infected and dying to begin with. I yield back. Chair now recognizes miss brooks for five minutes. Rep. Brooks thank you to all of our panelists. I completely agree with, i believe it was dr. Mcclellan who said it was so critically important to help us restore trust and make sure there is trust in the vaccines. I want to talk with you about the fact that we have these vaccine candidates in phase three Clinical Trials. We have already heard that they recently released their vaccine protocols, that the companies have, which contain details about how the participants are being selected and monitored, and the conditions under which the trials could be stopped early, if there were problems. And the evidence that researchers will use to determine whether people who got the vaccines were protected from covid19. I think it is unprecedented that the companies are making these disclosures at this point in the process. How does this level of transparency help of the experts, more importantly, the public . Mostnk thats what we are concerned about, the publics confidence in the safety. What more should they be disclosing about Clinical Trials . What should companies be doing to increase Americans Trust in the covid19 vaccine process . Dr. Mcclellan i think the companies have done a couple of things this time around that unusual. As you mentioned, more transparency than has generally been the case. Second, we talked about earlier a pretty extraordinary written letter from all of the Companies Involved in these Vaccine Development stating that they are firmly going to adhere to the fda processes. So those are really important. I know now people care so much about whats actually happening in these trials. We talked about before, there are just going to be some things that we wont know for sure for a little while. Are the events that are happening in the trials related to the vaccine . What do they really mean . When you get some of this transparency, it also creates some opportunities for confusion. For example, some of the studies, as is usually the case, have some review checks along the way by that independent expert group, the data safety monitoring board, and those may show that the vaccine is really working way better than people expected. That could lead to the trial coming to an earlier conclusion, at least in terms of leading to a proposal to the fda. That has gotten tied up in some of this discussion around, cut a vaccine happen before the election . Very unlikely, technically possible if there is just an absolute homerun, which i dont think we have seen evidence of the. Trials are still ongoing. Sure challenging to make people get transparency about the process, but recognize that we dont have answers for a lot of these questions yet. We really need to take the time for thetalked about, fda scientific review to happen on any emergencies proposal, for it to be presented in writing with fda comments and review to that independent Oversight Group before we reach any conclusions. The more we can keep the politics out of this, the better. O very quickly, dr. , we ared dr. Gayle so concerned about flu season, about children not getting , not justight now with the Covid Vaccine, but other childhood vaccines that we are seeing a decrease in the numbers. What are your recommendations for how we implement a better strategy in making sure that we are tracking flu and covid, and also getting children, making sure they continue to get vaccinated . Dr. Gayle . Dr. Gayle we really need to build on the existing programs that we have. We have such a strong system for childhood vaccinations that needs to continue to be strengthened. It also, as was mentioned in several other questions and by other panelists, we have got to restore the trust and confidence that has been eroded in vaccines. I think those two things for me are essential. Build on the systems that we know work, get the right information out, and continue to build on the messages on why it really makes a difference to have children vaccinated, and build on those systems that we know work. In my 15 seconds. Dr. Offit initially, what happens, because of the pandemic, there was a dramatic decrease in childhood vaccinations, as reported by the report. That started to,. People are more comfortable going to the doctors office, but you are right, we need to make sure we get a flu vaccine coming into this winter. I got my flu vaccine. Thank you. I yield back. Thank you. Chair now recognizes miss custer for five minutes. Thank you for this hearing. This is bipartisan. I got my flu vaccine as well. We are not trying to politicize. The president of the United States has politicized this vaccine coming just weeks before an election. We owe it to the American People to explain the process and the system and the transparency in the hopes that one of these multiple vaccine candidates will be proven safe and effective. That will be only half the battle. Once we have unapproved vaccine, we still face the formidable challenge of distributing hundreds of millions of doses around the country. This will be an unprecedented effort and we need to start preparations right now. Of then, what are some essential Lessons Learned from past Vaccination Programs, such , regarding thec novel use of a vaccine . Dr. Khan thank you, congresswoman kuster. I think it starts with appropriate messaging. Under promise, overdeliver, make sure we have excellent planning at all levels, local, national, state level, tribal and territorial level. Make sure we have prioritization. Not be enoughwill vaccine the moment it is released. That needs to be clear up front. Part of the planning needs to deal with the logistics. This is going to be logistically extremely difficult, unlike the h1n1 pandemic in 2009. In the end, there was only a need for one dose. In this case, you need two doses of the exact same vaccine 2128 days apart, which will be problematic. There is complex requirements for storing these vaccines. Depending on what the size of the orders are, those may need to be split up and sent to various places in rural areas. We talked about mass vaccination but we need to be careful about what the word mass means. You dont want hundreds of people gathered together. We would like to keep those two pieces apart, the infection and protection. There is going to be significant challenges throughout the system. I did not even get into the data systems. I was going to ask you further about one of the challenges with the Vaccination Program on this scale is data systems to track about distribution and schedule immunizations, especially if they need two separate doses. What should congress be insuring to make sure that we have good data on a Vaccination Program . Dr. Khan how do we strengthen the systems that are going to have to Work Together in terms of vaccine tracking, immunization registries in the state, the vaccine adverse Event Systems . There are three systems. How do you make sure those are working, robust, interoperable and will give you the data in realtime that you will need to where isat not just the vaccine being distributed, but actually giving it to people and what the side effects are . Out,vaccine is getting make sure that we are being equitable in the distribution. Thats only going to be determined by data. Is our existing Health Infrastructure adequate to meet the storage and Transportation Needs for national and equitable distribution, including rural communities, communities of color that have been disproportionately hit by the covid19 pandemic . And then, distributing a global vaccine will require extensive air travel via cargo flights. Do we have the workforce and capacity to achieve this logistical feat . Dr. Khan i think the one thing that does worry me is the requirement for at least one of the messenger rna vaccines to be shipped and stored at 70, 80 centigrade, which would require at least dry ice constantly being used. They are doing studies where i am sure the company has been very good about making sure there is no historical precedent for us maintaining vaccines on dry ice in the United States, thats never happened. I do worry about that. I think it will be an in normas challenge enormous challenge. Thank you, madam chair. I do appreciate holding this hearing, although i am concerned by the fact that everybody keeps bringing up not to politicize it, the administration is politicizing and. Thats exactly what this hearing is, we are politicizing it. Me you constituent tell can tell when a Natural Disaster or a nationals disaster is serious is when republicans and democrats are both on the same page. When we start politicizing it, it becomes less series. Thats exactly what we are doing here. We have members on this panel that are extremely biased towards the president. That alone drives down the confidence of the American People. Do they really need it . Is it really that serious . If you are in one of the vulnerable positions you need to get the vaccine when its available, not worrying about if the president brought it out too fast. Do we really think the pharmaceutical companies or the fda would allow that to happen . It is their name. They are the ones trying to get it to the American People to save lives. The more we question it, why underneath the disguise of trying to say we are trying to keep the American People safe, the more we can actually cost peoples lives. We need to be very careful about that. Everyone of us have a responsibility to the American People enter the public, regardless of if youre a witness or a member here. You yourself can be driving down the confidence of the American People. , ih that said, dr. Mcclellan would like to talk to you real quickly about the pharmaceutical companies and the vaccine. Do you think that the companies would knowingly produce a vaccine that is unsafe for the public . Dr. Khan no dr. Mcclellan no, representative, i dont think so. They have affirmed the same thing in writing and they are affirming it by following the fdas guidance on how to conduct the development, the Clinical Trials, and making sure they are doing safe manufacturing. Under President Trumps administration, do you think the pharmaceutical companies or the fda are cutting any corners and developing the Covid Vaccine . Dr. Mcclellan the warp speed process is happening much faster and i know that makes people nervous. Its important to recognize that fda is firewalled off even from warp speed. The work they are doing in supporting these very large trials and an unprecedented pace is different from the review that is going on independently by fda. It is sort of like independent oversight within this very accelerated process to make sure that we are not cutting corners on the safety and effectiveness. Panelistsny other like to add to that . Ok. If not, we will go on then. Thate you confident then when a vaccine is authorized, that it will be saved to the public. The other former fda commissioners, the group all stated their confidence in the fda process as well. We have heard that from dr. Tony fauci, dr. Francis collins, from other Public Health leaders in and out of the administration. Thank you so much. I dont have anything else. Thank you. The chair now recognizes congresswoman castor for five minutes. Thank you chairwoman for having this very important hearing today on how we can ensure a safe and effective Covid Vaccine, covid19 vaccine. The experts have been direct and straightforward and simply outstanding, very helpful. You simply cant to gloss over the fact that the administrations Public Health response to covid19 has been weak and overly politicized. D ahas cost lives, cause lot of pain. The importance of developing a safe and effective vaccine is paramount. Once a vaccine is approved, we will face the daunting task of distributing it across the country. For that effort to be successful, everyone must Work Together, federal agencies, states, territories, local and tribal communities and our public out agencies. I asked thehearing, vaccine manufacturers about the importance of our state and local Public Health professionals in Vaccine Distribution. Local,l agreed that our trusted Public Health agencies are critical to successful dissolution. Across americas are very diverse and covid has laid bare many weaknesses in our longestablished Public Health infrastructure. It will be more critical than ever that our state and local Public Health professionals are empowered to implement an effective and timely Vaccine Distribution. You point to this infrastructure as a key component of a successful covid19 Vaccine Distribution and uptake, stating that we canleverage our nations existing Vaccine Distribution infrastructure to ensure efficient and equitable aspects to covid19 vaccine. As thele will they play partners for effective distribution . And do you want to highlight any weaknesses in that infrastructure now for us to address . You, congressman castor. We dont need a vaccine. Fromow from experience china, vietnam, thailand, new zealand, taiwan that you can get pretty much to zero cases based on good Public Health practices. Those would be the cdc guidelines that i discussed previously and guidance. We know a vaccine is critical and will help her do this but we know we can do this without a vaccine with the Public Health tools that we have today if you want to. Critical to make that happen is that we have strong state and local, tribal and territorial infrastructure to do what needs to be done. To ensure Community Engagement around wearing masks, social distancing, and handwashing. Dr. Offit and others have highlighted why it will be more difficult than what we have done for example in 2009. Do they have the people necessary to do all of this . This is not just that epidemiologists. It is the epidemiologists, health communication, laboratory people, publichealth advisors. It is a core of people that we need to make sure that we have to ensure that this vaccine is wellplanned, can get out as it needs to get out within our communities. Rep. Degette what is your view . You have devoted your lifes work to publichealth and boosting our trusted authorities and that infrastructure. What do we need to be focused on right now . What we really need to do is to make sure that we make it possible for the systems that we know have delivered for decades and decades have what they need to be successful. So, all of the things that people have already talked about around building those systems starts with building the confidence in those systems, adequately funding those systems, making sure that we have the personal, and then making sure that we have the data systems in place that are going to be so important for continuing to track the distribution. Also, i think rep. Degette im afraid, because i have watched in my home state of florida over the past decade, or the Public Health agencies, they have let them wither on the vine. We dont have the same kind of infrastructure in place. What can we do about that . part of it starts with having the right kind of National Leadership in place. It has always been important that we have a strong cdc, that the other agencies that are involved in the immunization programs are fully funded, have the support that they need, so it starts with national guidelines. National you have to have those systems in place, with the national guidelines, infrastructure, and make sure that those are then being partnered with state, local, and territorial leaders who really are the ones who can get to the people and make sure that these programs are implemented. It takes having that whole system. You cant have these fragmented systems. You need the whole system working in tandem. Thank you very much. Rep. Degette chair now recognizes mr. Duncan for five minutes. Duncan a hearing entitled pathway to a vaccine ensuring a safe and effective vaccine people will trust has taken a lot of different paths today. It has been very interesting to hear the comments from my colleagues in congress, but also the panelists. Ans comments kh about we dont need a vaccine, we can do all these other things, and we are spending billions of dollars on development of a vaccine. I dont disagree with him i believe in. Herd immunity, taking those necessary steps. We can probably eliminate a lot of folks catching the flu, yet we push a flu vaccine every year. Its just kind of interesting to hear the banter back and forth. We talked about how this thing, you are not tried to politicize it, but you are doing exactly that, not pointing out that the president said this, that, on the other. The president is a Real Estate Developer and businessmen who had to rely on the cdc experts to give him the advice. They have been all over the board. If they are advising the president and he seems to be all over the board, it is because of the advice he has been given by nonpartisan members of the cdc. And other organizations that advise him. Mcclellan, your. Know, i understand that fda vaccines and related biological products Advisory Committee, an government form of and pharmaceutical companies, they review and a bill you wait and evaluate data on vaccines. Why should the American People have confidence that this committee will provide unbiased recommendations regarding a covid19 vaccine to the fda commissioner when we have seen so much partisan rhetoric from all fronts, not just my colleagues, but really the media and other groups . How can we have confidence that this committee will provide unbiased recommendations . Dr. Mcclellan i have a lot of confidence in the committee. It goes from my own experience. I was fda commissioner, not at a of this level publichealth emergency. The agency is used to getting pressure and different views, both political pressures and from scientists, who sometimes have different views and interpretations of the evidence as well. The evidence evolves over time. What we thought might be the best answer in february is not rep. Duncan let me stop you right there, dr. Mcclellan. You just said this was, i know coronavirus. El we are learning things about the virus from the time it came on the scene in january until today. Things that we learn, we shift course, right . They are saying the president has lied to the American People, basically shifted course based on the knowledge of the virus. Would that not be fair to say . Dr. Mcclellan do i trust the Advisory Committee . I trust that they will bring all this information together and oversightas expert and experience to enable fda to make an informed decision that reflects all the science. That is a process we should have a lot of confidence in. Let me talk to dr. Offit. There was a question on how they would create a vaccine and affective for the most vulnerable the population. We know who the most vulnerable are. Did, youerview you stated regarding individuals in the 65 and up age group, i cant would ever allow a vaccine to be recommended for that Group Without having adequate data. Do you stand by that Statement Today . Dr. Offit sure. I am on the fdas vaccine Advisory Committee. I can tell you how we operate. We operate as scientists. Thats what we are. Politics does not enter that at all. Do you think dr. Fauci has operated as a scientist . Dr. Offit absolutely. I think dr. Collins and dr. Redfield have operated as scientists. Thats what i think. Duncan dr. Offit i believe they have operated as scientists. We learn more and more about the has beenit evident the publishing. As the data comes in, remedies and other things will change. Dr. Offit you always learn as you go. You always have to be openminded. What do we know . We know that masks work. Even though you will have rose garden meetings or these rallies where everybody is inside not wearing a mask. Rep. Duncan what about protests . Dr. Offit convalescent plasma has no evidence that it worked, but it was push. I dont understand why we are having this meeting. We should not need this meeting. We dont trust the fda largely because of what has happened with the administration pushing the fda to do things it shouldnt be doing. Thats why people are upset about this. [crosstalk] thanks, madam chair. Can you hear me . Good. Rep. Degette i can hear you, yes. I want to return to a topic that has been touched on because i am very concerned about this declining confidence we see in the public when it comes to the Covid Vaccine that we are working on. We have seen that confidence decline over the last few months. Retty precipitously i in a pew survey, only 51 of u. S. Adults now would get a vaccine if one were available. Thats down from 72 in may. A Kaiser Family Foundation Poll found that 60 62 of americans worry that political pressure from the Trump Administration will lead fda to rush in its approval of a vaccine without making sure that it is safe and effective. So thats not a good situation to be in. Its very alarming, as we are trying to tackle this pandemic. In your testimony, you emphasized trust of the vaccine will be as important, if not more so, than safety and efficacy. Thats a pretty powerful statement. I wonder if you could elaborate on it . You always think efficacy and safety are rated at the top of the list, but you are saying you have to put trust up there, or else it will not be effective. Dr. Khan i will give you two specific examples. The first was with the h1n1 outbreak in 2009. Individuals failed to get vaccines when they thought they were supposed to get, in the end , i believe only about 27 of americans get vaccinated. We did not vaccinate as Many Americans as we would have wanted for h1n1 because of this mistrust in what they were being told. The second example is for highly efficacious lyme vaccine that was taken off the market, not because of any concern about efficacy or side effects, but and efficacyeived and side effects efficacy and side effects. It was pulled off the market. Trust was really critical to allow us to get to the Vaccine Coverages we would have liked. Howou are pointing to tenuous this trust can be with the public and how careful we have to be in the process in convey that sense of comfort and safety and efficacy that will allow people to take advantage of this opportunity when it presents. Thats whats really at stake here. I think its cause for real concern. You said in your testimony, the administrations arization of science causedization of science some to wonder whether the same low standards would be applied to covid a Covid Vaccine. Answer this for me. We could go a long way towards restoring trust, could we not, if the president , if the administration, the political people, in other words, not the Public Health experts, but the political folks who operate in this space, beginning with the president , who is, you know, leading the executive branch, if they would align themselves with publicHealth Experts and follow them . It doesnt mean you dont watch over the process. It doesnt mean you dont kick the tires and make sure it is being vetted properly. You could convey broadly your view that the Public Health experts, the scientists, the people that are most knowledgeable in this field are the ones that are going to call the shots. Quickly, ift very that was the posture the president and the administration took, couldnt that be to restore trust in a meaningful way . Could you speak to that . Absolutely. People look to the president for leadership. Other countries have done much better on getting on top of this pandemic. We havent. The biggest reason is that hygienic matters. It is more powerful than vaccines. A couple weeks ago at Childrens Hospital, philadelphia hospital now loaded with children who have covid19, if you give me the choice of a mask or vaccine, i would choose the mask every time. It is such an important, powerful to. I think the president could do so much to promote that and he doesnt. I grew up in baltimore, maryland. Huge fan of your father. I would just say that if you are fighting with the Public Health experts, you are politicizing this. If youre aligning yourself with them, your depoliticizing it. I yields back. Do we have mr. Burgess on the phone . I dont see him. Going once, going twice. Mr. Peters, i will recognize you for five minutes. Sorry about that. Would just offer a lot the questions have been answered, but just to follow along, i guthrieu and mr. Deserve credit for putting on this hearing. The idea that it not be political. I think to even throw a bone to administration, i like the idea of the way that dr. Fauci has characterized this warp speed effort. , is tofort, by the way accelerate manufacturing once a safe vaccine is developed. He has emphasized over and over again that the risk we are taking is a financial risk. I think that is totally appropriate. Once you have that formulation, that you would be able to hurry up in making it available. I think that makes all the sense in the world. I think it is important for all of us, and you may call this political. If anything you say against President Trump is necessarily political, then it is blue. You cant set a date for this vaccine to be safe. That is something that has to follow through the process of that we have developed over many years and which we are not just lucky to have, but we are smart to have in our country to develop these vaccines. We have the confidence that our Public Health infrastructure, from research to industry, can come up with a vaccine. I think we all believe that thats true. We would maybe like to see a one does vaccine, but in any event, i dont think its inappropriate to call about any politician who suggests that that time i should be modified to fit a political schedule. I would just say that i appreciate the testimony of the witnesses and i wheeled back i will yield back. Agree with your comments. Clark on the. Phone . Oh, there she is. Your recognize for fiveminute. Rep. Clark thank you so much, madam chair. I have been listening attentively at so much and so much of the concerns we have have been responded to. I want to raise the issue, being a new yorker who was at the ,picenter of this outbreak around things that we can do to how wedrill down on continue to protect ourselves. I am concerned about the mixed messaging around the publichealth protocols that have been working in tandem with our awaiting of the vaccine. We know that todays hearing focuses on what much of the world is eagerly anticipating, the approval of a safe and effective vaccine for covid19. We are all rooting for that, but we all must keep in mind the bigger picture. PublicHealth Experts have been warning for months that an eventual vaccine, while critical, will not be a Silver Bullet that instantly kills off this pandemic. I really want us to drill back home with the American People when i see there being some retreating from the initial protocols that have brought new york city down to record lows. We are beginning to see small ticks. Up it is because, i believe, people are beginning to relax around those publichealth protocols. We can all agree that a vaccine will be a critical tool in this fight. Why wont this be like flipping the switch . Will a vaccine alone be enough to stamp out this virus . Or will we need to rely on other Public Health measures to some extent . Thank you for that critical question. Of course, we all wish it would be like a light switch that we can flip on and move forward. There are several reasons why it wont be that way. Even under the most optimistic scenarios, i do not expect a vaccine to be 98 or 100 effective. If it is 70 or 80 effective, that would be terrific. There is so little we know about what will happen after you are vaccinated, about your ability to transmit to others. It may be that you are vaccinated, you may be protected but still able to transmit to others. It is on highly unlikely that 95 of americans will get vaccinated. A lot people wont take this. 70 of americans get be vaccine, which would wonderful and 70 efficacy, that does not get you population level everything is done. It will be immensely helpful. It will allow much of our lives back. There will be some highrisk things that we will continue to manage very effectively. We will have to continue to avoid large, indoor gatherings without masks. A lot the things we care most about, schools and work, a lot of people a lot of that will be possible again. It is not a Silver Bullet. 2023, we will2, still be dealing with this virus but hopefully much better off than we are today. , we cannot you state wait for a vaccine to contain this outbreak. We must use the publichealth tools we already have available. How does a vaccine fit into the larger Public Health strategy for fighting covert 19 vaccine covid19 vaccine if it will not be Silver Bullet and instantly end the pandemic . To unmute. Ou have dr. Khan thank you. The doctor has stated why a vaccine itself is not sufficient. Vaccine needs to sit on top of a publichealth response. We know that this publichealth response can contain disease from experiences in a not just now multiple countries, but what we saw in new york and what we are seeing in a lot of the northeast. We know these publichealth measures to make a difference. Know what the controlled is. The first is integrated, coordinated, local, state, and National Leadership that is evidencebased, consistent messaging, looking at metrics. Number one is leadership. Number two is drive down community transmission. Increase Community Engagement. That is masks, handwashing, social distancing. Number four, which we are doing a very good job at, is decreased deaths amongst people who unfortunately still get infected. Our Case Management has markedly improved. Haveherapeutic options markedly improved. Those are the four things that we need to do. We still have not fully implemented those in the United States yet, which is why we see day, and why we cannot wait for a vaccine to down to zeroaths or as close to zero as we can get. After having to experience what i did in new york city, it pains me to see the rest of the nation going through what it is going through. They have not learned from our experience, and what we have done to keep our curve flat. I hope that this discussion today in collaboration with the vaccine will really provide a parts ofroadmap for the nation that are still struggling with the answer to keeping americans safe. I yelled back. Thank you so much. Of the members of the subcommittee have asked their questions. I am pleased that we are joined by several members of the full committee. I am going to start with congressman carter. Your recognize for five and its you are recognized for five minutes. Thank you for allowing me to participate. As a practicing pharmacist over 30 years, confidence was extremely important. , an i recommended a product overthecounter product to a patient, it was important for me to be confident and to exude confidence that this was going to work for that patient. That, we spent a lot of time today talking about the politicizing, if you will, of this hall vaccine and this whole process. As a health care professional, as a pharmacist, i find it irresponsible that members of congress would be doing this. This is something that we show all be together on. I have dealt with the fda, i have seen the process work. I have seen products that went all the way up to the fourth stage and then were not allowed to go any farther. Ive seen that happen. Up confidence in me in knowing that the process works. That is all i am going to say about politicizing this ordeal. I want to talk about distribution of this, and making sure that we have a process in criticalecifically the aspect of allowing pharmacist to be able to administer this vaccine. Dr. Mcclellan, i want to ask you, 95 of all americans live within five miles of a pharmacy. Pharmacist ares the most Accessible Health care professionals in america. In order to make sure that when we get this vaccine safe and effective and when it is out there, and we are going to make sure that it gets out, would you agree that pharmacists need to be able to administer this covid19 vaccine . Dr. Mcclellan i agree. We have got experience in the pandemic of pharmacists playing a Critical Role in access to testing and helping people respond more quickly, get greater access there in helping with flu vaccines and other issues that also play into the pandemic, as we talked about already today. They are also an important part of that trust. People still trust their health professionals, doctors, pharmacists, even if its gone down for fda unfortunately. Thats another check on making sure we will have an effective vaccine that can be brought to the public. Pharmacists have a Critical Role to play in this. One of my favorite stories is the fact that i went from being a pharmacist to being a congressman, the second least trusted profession in america. The point im trying to make is that it is important for pharmacists to be able to administer that. Weve got a situation where a lot of the states have authorized it, but we need a blanket policy, if you will, so that we can have all pharmacists, whether it be independent retail or chain retail, to be able to administer this to get it out quickly. You are a former cms administrator. I wanted to ask you, you are aware of the issues that deal with pharmacists getting reimbursed and being able to bill medicare for these types of things. This has led to a lot of problems. Right now, we are trying to get a temporary pharmacist provider status so that pharmacists will be able to get reimbursed for administering these vaccines. Obviously, we have got to have insurance, coverage, everything that we should have in order to administer these vaccines. That is something we have been working with cms with in trying to get that done. Do you agree that congress should grant temporary authorizations for pharmacists provider status to be able to administer this vaccine . Dr. Mcclellan if thats what it comes to. Cms has authority to expand the scope of practice and coverage, any Public Health emergency. We did that in circumstances like an hurricane katrina. Edentsare some prec for handling this. There seems to be broad agreement around the fdas process of approval to make the vaccine available. We all have work to do together on the distribution and access to the vaccine, where that depends a lot on, you know, i would love to see more activity at the state and local level focusing on that, since we do have a good program in place for the safety of the vaccine itself. Rep. Carter again, this is not a partisan issue with pharmacists being able to be granted provider status in order to distribute and administer these vaccines. I would solicit your help as well as my colleagues on the other cited the isle as well as myne on this Committee Colleagues on the others of the aisle as well as everyone on thank you,tee, and i and i yield back. Youve raised an excellent point. Millions of americans get their flu shots right now at workacies, so we would together with you on that. I would like to recognize ms. Dingle for five minutes. Representative dingell thank you, madam chair. I would like to tell my colleague from georgia, when we know the vaccine is safe, i trust distribution capacity. Aboutne has been talking all day, both witnesses and members, about ensuring any potential vaccine is safe and effective and making sure it is available is going to be critical when we know it is safe. Committees the constructive role in helping shed light on the challenge we face. Noted in your testimony that while we sometimes accepted potential a certain level of ential harm, it seems like i believe weve lost [indiscernible] can you hear me . Yes, we can hear you now. I believe i have the gist of the question [indiscernible] you point out, was [no audio] hear me . . You know what he thinks he gets the gist of your question, so we will go ahead and have an answer. The question is really important, and this is an important point i think the American People need to understand, that we do use a different bar for using emergency youth authorization for therapy because these are for sick people who otherwise might die and you have a lower threshold for what you would call effectiveness and when you give vaccines, youre giving it to Healthy People. Protect Healthy People by having people wear masks, by doing social distancing, by all the things we know about, so you have to have a relatively high bar for the authorizing of vaccines. This is a basic principle of medicine, first do no harm. You have to have clear evidence you will do much more good than harm to that person when you intervene medically. That is one reason why we all have said this, and the processes of the fda around vaccines have acknowledge this and i think have been built around it, but it has been really critical to all of us those processes be followed in the covid19 Vaccine Development and approval. I am not an antivax or so ie make that clear did have [no audio] you are frozen again. Representative dingell ill yield back. all members can submit questions for the panelists in writing, so we can have you do that. The chair now recognizes mr. Bill ruckus if he is still with us. I see he is sitting down. [indiscernible]. You need to unmute where did he go . Ok, weve lost mr. Bella rock us, so im going to recognize mr. Ohalloran for five minutes. Ohalloran thank you and thank you to the panel for all the information they put forward this morning on this afternoon. Over the past six months, this committee has held multiple hearings featuring Public Health experts and officials as well as witnesses from pharmaceutical Companies Involved in development and manufacturing of the vaccine while discussing the Public Health response to the coronavirus pandemic. Through the cares act and as we madeseen the government significant investments in a bipartisan way in the private sector to manufacture and scale a vaccine to protect americans from the coronavirus. Ofly reports on developments vaccine are promising. The release of an effective vaccine to market will mark a milestone and serve as an to finallyeapon defeating a public of crisis, but americans are confused. A Pew Research Center poll released just two weeks ago showed that only 51 of americans, adults, would definitely or probably get a covid19 vaccine if it were available today. These members represent a 21 drop from survey numbers released in may. This has the potential to be of massive concern. I also want to address the issue of what this means to development of future vaccines and future medicines as we go injectingh of politics into this process. And is about scientists researchers and process as it has been for many decades. We need much transparency from vaccine train your vaccine manufacturers, Public Health agencies like fcc and nih, so the public knows the vigor and scientific discovery going into these products. Unfortunately, we are seeing the current process has cast doubts healthapolitical public agencies. We need clear and straightforward information from our leaders to ensure that americans are vaccinated when these products are brought to market. Further communication is also needed from pharmaceutical companies. Andr role is critical, their business depends on public vaccines work as intended. The American People need unprecedented transparency from tormaceutical companies explain what various trial stages mean, what the side effects are and eventually when a vaccine is approved, are there may be given the drug, are they compromised in any way . This first vaccine will hopefully not be the last vaccine and hopefully will not be the only vaccine. Can you talk about how political intrusions into Vaccine Development process are harming Americans Trust in our Public Officials and Public Health agency . And importantly, how this will be undermining the importance of americans being able to be safe andd when a effective vaccine is approved . Thank you. Thank you for that very important question. The bottom line is that so far, the scientific integrity of the process has been superb. Really worldclass scientists working in the private sector, working with nih to do what i think is an unbelievable job in bringing a vaccine forward in record time of the problem is that when i speak to people working on the Clinical Trials, they cannot give me a date. They dont know when a vaccine is going to be ready. There are processes for looking at the data. There are independent boards that are going to be different. What we all want is we all want a vaccine yesterday, but we want a vaccine that is going to be effective and weve got to let the science lay that process out, and it makes me very anxious when i hear ceos of companies who technically dont have access to the data or political leaders who are picking specific dates and saying we will have a vaccine by a specific date. I know they dont know what they are talking about. But it makes the American People deeply concerned because they safeguardsall of the , and we all worry those will be undermined. What ive been asking is for politicians to basically be quiet, to knock it off, to stop talking about dates. Let the scientific process move forward. Scientists will declare based on scientific principles that the vaccine is ready for authorization and eventually approval, and not a day before that, unfortunately. Thank you. I yield. Thank you so much. S, you have the last word. Representative bill rockets thank you, madam chair. We had some technical issues before. Thank you for giving me the time. I understand youre here in your capacity with the National Academy, but given the importance of enrolling diverse populations in largescale covid19 Clinical Trials, i wanted to ask if your organization, the Chicago Community trust, has undertaken any efforts to promote and encourage participation in Clinical Trials among racial and ethnic minorities, and if so, would you be able to share the details of those efforts . Thank you so much for your question. I would just say here in chicago, we have an Outstanding Department of Public Health that has really wonderful relationships with the community. We continue to work with them. We have had a really close relationship with them throughout this pandemic and we will continue to work with our department of Public Health to make sure that these efforts actually serve all people. We dont have specific details, but just to say this is something we here in chicago feel is incredibly important, and we always put Health Equity at the center of the work we do in Public Health. We will stand by our Public Health department and make sure that we can be part of making vaccine is safe and available in an equitable fashion and our guidelines we are talking about in this hearing put a real focus on equity and on Mitigating Health inequities because we know there has that has been so much a part of the pandemic that highlighted the longstanding Health Disparities that exist in this country among people of color, so this is going to continue to be a big focus for us as an organization, and clearly, it is something highlighted in our report. Thank you. Out how can we reach out tell us how to reach out to communities and groups that are disproportionately affected by but have high rates of Vaccine Hesitancy, and who are the most effective messengers to these communities . I think this is so vitally important. Dr. Kohn dr. Kahn i would say you need to reach out to them for their concerns about covid19 affects people of color, their access to care, so that needs to be done by local and state health department, working with local community organizations, make sure you are engaging those organizations, including faithbased organizations in that work, so that is the good Community Engagement work you need to do, and as part of that work, you can help protect that Community Today with tools that are available to us. Please make sure you make yourself available for Contact Tracing if somebody calls. Please wear masks. Wash your hands, social distance. Working with the community not to decrease transmission, that will markedly increase the trust once the vaccine comes in to help all of our communities get vaccinated. Are you familiar with the Vaccine Hesitancy and Education Programs . If so, can these programs help increase Public Confidence and increase immunization rates . I think people who are hesitant about the vaccine are and skeptical about everything including vaccines. If you asked me if i would get a covid19 vaccine right now, i would say no, i want to see the data first. Is use what you do reason and logic and passion and compassion to try to explain those data, to frame those data in an emotional and human story that let people know that a isice not to get a vaccine not a risky choice. You have to explain, heres what we know. The vaccine is safe in 20,000 people. That does not mean it is safe in 20 Million People. We know the vaccine is 75 effective, but we dont know how long it is effective. We will know that over time. The question is not if you know everything you dont know everything. The question is when you know enough and if you dont, how you will find out. I think there is a group and much Smaller Group i would call antivaccine activists, people i would largely call conspiracy theorists. As noted tyson says, if someone comes to a conclusion without using logic or reason, youre not going to talk them out of it using logic or reason, and i think that is the case here. I would say 85 of the people who are concerned about vaccines are reasonably concerned and can be i think talked down as long as you provide data and clear, compelling, and compassionate data. Thank you, gentlemen, and i want to thank all the witnesses. I think i can speak where everybody on both sides of the the integrity of the Research Process that weve had so far has been superb. We have the pharmaceutical working through operation warp speed, and we are hoping we will get a vaccine as quickly as possible, but that we really cannot i think as you and the other panelists said, we cannot force a timeline, and all of us just have to be ready to accept the timeline we hope its fast, but we cannot be saving dates. It includes not just meddling in the Research Process, but also announcing deadlines or reallyes before they are appropriate. I think it is imperative that we follow the contact. Its imperative the public has access, and thats what this hearing was about today. Pete frequent the, people ask me why we do oversight hearings. The reason is to shine a light because sunlight is the best disinfectant and we think the more we have experts like you coming and talking about the process and what we need to do that the more likelihood it is that we will have a process that will not be meddled with and that will produce not one but we safe and effective vaccines. I want to remind members that they have 10 Business Days to submit additional questions for the record to be answered by the witnesses who appear before the subcommittee looking at you, representative dingell and i also want to ask that representatives respond quickly to any such questions, should you receive any. E have some documents we have mr. Waldens request. Project, theve Clinical Trial protocols for four covid19 vaccine manufacturers. The letter signed by nine Drug Companies touting the safety of any covid 19 vaccine, the fda information on covid19, usta opinion dated september 10, 2018. We have the Washington Post opinion from seven former fda commissioners of the Trump Administration undermining the credibility of the fda dated september 9, 2020, which i offered, and we have the oxfam report on the worlds covid 19 vaccine supply dated september 17, 20 20. Objection, these articles and information will all be entered into the record. With that, thanks again to everyone. This committee is adjourned. Heres a look at our live coverage thursday. On cspan, the house is back at 9 00 a. M. Eastern for general speeches before returning to legislative is in us at 11 00. Members may consider it a coronavirus economic aid package that provides another round of direct payments and emergency funding for state and local governments, schools, Small Businesses, the airline industry, and covid19 testing. At 7 00 p. M. Eastern, our campaign 2020 coverage includes President Trump and joe biden speaking at the annual Alfred E Smith Memorial Foundation dinner. On cspan2 at 10 00 a. M. Eastern, a House Oversight hearing on Prescription Drug pricing. Then the Senate Returns at noon to consider moving forward with a bill from senator Chuck Schumer that dance the Justice Department from supporting lawsuits that strike down the Affordable Care act. On cspan3, the Small Business administrations Inspector General testifies at a house subCommittee Hearing on preventing fraud and abuse within the paycheck protection loan program. There are several events streaming live on our website thursday. At 9 00 15 a. M. Eastern, a Senate Armed Services subcommittee examines the Defense Department medical equipment supply chain during the coronavirus pandemic. At 10 45 a. M. Eastern, House Speaker nancy pelosi holds her weekly news conference, and at 1 00 p. M. , our campaign 2020 coverage includes Vice President pence speaking at an event in council bluffs, iowa. Again, thats all live at cspan. Org. Trump telling us not to worry, that the virus will disappear, that a miracle is coming. Joe biden saying, we need a plan, a national strategy, a president who is willing to lead, willing to be a role model for our nation. Set at theirbiden National Convention that no miracle is coming, we actually be a shortght just time away from when america will produce the first safe and effective coronavirus vaccine, and we will begin to deliver it to the American People the moment it is approved. President ialvice debate between Vice President mike pence and senator kamala the universitym of utah in Salt Lake City and stay with cspan for the second president ial debate town hall with President Trump and former Vice President joe biden, taking audience questions. In miami thursday, october 15. Watch the debate live on cspan. Listen live on the cspan radio cspan. Org debate for live or ondemand streaming of cspan. See social media feeds on debate happenings and reaction, and watch archival president ial debate video from the cspan video library. Next, President Trump speaks at a rally in duluth, minnesota. This was his First Campaign event following tuesdays debate with former Vice President joe biden. Ladies and gentlemen, please welcome the president of the United States, donald j. Trump. [proud to be an american playing]
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