Transcripts For CSPAN2 House Hearing On COVID-19 Vaccine Development 20240712

To unmute your microphones anytime you speak. If at any time during hearing im unable to chair the hearing the human chairman colon or vice chairman of the committee congressman kennedy will serve as chair until im able to return. Documents for the record can be sent to Benjamin Tabor at the email address weve provided. All documents will be entered ininto the record with the inclusion of the hearing. The chair will not recognize herself for an Opening Statement. Today the energy and Commerce Committee continues itser oversight of the nations covid19 Pandemic Responsee examining a safe and effective covid19 vaccine that the American People can trust. In the eight months we battled covid19 over 7 million americans have had the virus and tragically over 200,000 have lost their lives. Millions ofll people face on employment and have lost their Health Insurance and families are still juggling childcare and virtual classrooms. The list of those most vulnerable to covid19 is especially on the line is the virus continues to spread around the country. We know a safe and effectiveus trusted Covid Vaccine will be a critical tool to span this pandemic. I believe i enjoyed everybody in this hearing and everybody in this country and hoping that a vaccine is available as quickly as possible. The summer we held a hearing with five of the leading companies who are working to develop a covid19 vaccine. The companies assured us that while the pace of the vaccine is really unprecedentedsc safety ad science are not going to be sacrificed for speed. Last month these Companies Join for other manufacturers in a rare joint pledge stating that they withstand with science and not put forward a vaccine until it had been thoroughly vetted. Honoring this commitment will be critical as a future success of the covid19 vaccine depends on the American Public confidenceth that it will be safe and effective. Alarmingly, the public trust in the future Covid Vaccine pandemic has declined vaccine in just a few months. Nearly two thirds of american worried that political pressure will rush approval of the covid19 vaccine and more than half say even if it were free it they would not get vaccinated before election day. Time and again throughout pandemic the Trump Administration has politicized science, undermining its own Public Health experts at every turn and in fact, just last night in yesterdays president ial debate meltdownan President Trump helped process a quote, very political thing. The white house and the hhs leadership has interfered with cdc guidance and other scientific publications for political purpose. The white house has publicly pressured fda to issue emergencf authorizations for covid19 treatments despite objections from fda scientists. And the president unfortunately has attacked the credibility of his own Public Health leaders. For example, just hours after cdc director redfield has edapplied the effectiveness of face coveringsgs and potential r the timeline of the taxing President Trump will depress the doctor redfield was quote, confused and had made quote, a mistake. E the president s has politicized the9 pursuit of the covid19 vaccine repeatedly by claiming it will be available in october before a quote, special day. Obviously, referring, to electn day and he did that again last night. The president has even accused his own fda of being part of the quote, deep state to slow walk of vaccine to hurt his political process. And just following the reports that the fda would be publishing additional standards for emergency authorization of a covid19 vaccine President Trump falsely claims that the guidance was politically driven and they were praised by external experts but it may not ever see the light of day because of the president s [inaudible] this oversight subcommittee has been sounding the alarm on the administrations dangerous politicized nation of science frankly, we are not alone in our concern. Last weekk the National Academy of scientists took the step of issuing a statement that the repeated politicized asian of science quote, undermines the Health Agencies and the publics confidence in them at a time when we need them most. As we will hear from our witnesses there are ample reasons to be optimistic with search for a Covid 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 but allowing the time necessary to conduct robust review of Clinical Trial findings and they must let fda release the additional standards for emergency use authorization of a covid19 vaccine developed. All of us on this committee, democrats and republicans, are rooting for a safe, effective and trusted covid19 Vaccine Accessible to all americansns ad we will continue our oversight to tell these goals are met. It will also call for a comprehensive vaccine plan. I look forward to hearing from oe panel today hopefully our wonderful experts can help guide us on ways to ensure that the public has full confidence in a covid19 vaccine once it is made available. I also hope they can provide Additional Solutions and suggest guardrails that will ensure that science and not politics guides the way because the health of our nation depends on it. Im very pleased to recognize our Ranking Member mr. Guthrie for five minutes for the purpose of an Opening Statement. Thank you, chairwoman. Thank you for holding this hearing about the covid19nk vaccine pathway but ultimately it will offer us the best chance to finally end this pandemic allowing our nation to fully reopen but it is not just a vaccine itself but in addition to approved or authorized vaccine we will need widespread acceptanceil, distribution and immunization to successfully iscombat the virus. The purpose is bipartisan hearing should be to increase Public Confidence in the food and Drug Administration and its process for authorizing and improving vaccines through science based decisions that are meant greater Vaccine Acceptance and confidence among americans prayed confidence through this committee created the emergency pathway as part of project [inaudible] back in 2004 and later expanded that pathway in the pandemic and all hazard preparedness reauthorization act of 2013 on a bipartisan basis through those efforts we provided special authority to the fda to use a Public Health emergency prior to a full eapproval when the scientists evidence is there to support such use. To receive emergency youth authorization a drug company must demonstrate based on a total totalitarian the of evidence for drugs known to unknown for potential benefits outweigh the known and potential risks. If da can apply that standard appropriately to different settings such as requiring more rigorous evidence for treatments used on healthier populations that of hospitalized patients. For covid19 vaccines fda has announced its using an ea you, ea youin plus approach. Through a guidance saying a much more stringent standard than for other ea use but unfortunately i have grave concerns that some care trying to score political points by irresponsibly criticizing the fda and its vaccine and approval process potentially undermining trust in the fda authorized vaccine, especially during this Global Pandemic and National Health emergency. It is understandable in this politicized environment that the public money will be concerned about theve Vaccine Development and approval process for the corners are being cut and unfounded criticisms circulating. The truth of the matter is the rereview and approval stages of the vaccine will be controlled throughout the process for nonpolitical independent scientific experts, not politicians. The data produced during the areine Clinical Trials edreviewed and evaluated by data safety monitoring board which is composed of independent scientific experts. In addition, there is an fda vaccine related by biological products from an Advisory Committee with an independent, leading medical experts were expected to review data on the vaccine for public meetings. Indeed, Even Congress has contributed giving scientific decision from the fda. It was this committees full Committee Hearing in june and other Committee Hearings over the past few months were congress and the American People received assurances from fda commissioner steven that he would support his career scientists and fda would not cut corners on the safety or efficacy of covid19 vaccines. The intense scrutiny is led to extraordinary pledges from highly respect to public officials. Doctor peter marks, director of fda center for biologics said he will resign his position if the fda were to greenlight an unproven Coronavirus Vaccine. In addition, the director of [inaudible] doctor Francis Collins and director of National Institute of allergy and Infectious Diseases doctor Anthony Fauci has said they will only back a vaccine that has Science Behind it. Further, nondrug committees have already pledged and they will not submit vaccine candidates for fdada review until their safety and efficacy is shown in large Clinical Trials. In addition, each off the four companies now in phase three Clinical Trials protocols. Vaccine distribution to independent committees will provide guidance. Of National Committee science and engineering on medicine and cdc Advisory Committee on immunization practices. I urge each of us to put alex aside and i know we are a few weeks from elections but put it aside to deliver one unified lifesaving message that americans can trust the fdas vaccine approval process. They will be driven by the science and will result in science based decisions. Lastly, the reminder for everybody to get your flu shot that has been this year will be more important than ever of and ive already received my flu welcome them to this hearing and i yield back. I think the gentleman. I got my flu shot two. Everyone should get their flu shot. We will not reckon i was the chairman of the subcommittee for five minutes. Thank you, chairwoman. Today we will hear from some of the nations leading Public Health experts on one tool that could help put an end to the pandemic and the suffering and that is a safe and effective trusted covid19 vaccine. I am pleased you are all with us today so with expertise in science has the rightful place in these discussions but we all won a covid19 vaccine to be developed as soon as possible but first and foremost we must confirm that it is safe and effective and we must ensure it is trusted and accessible to all who need it but as i said in our july hearing the vaccine manufacturers my fear is the Trump Administration might force the fda too approve a vaccine before proving to be safe and effective and in an effort to boost thepr president s politicl fortune and i hope that doesnt happen and i am grateful that career fda officials have repeatedly stated the importance of putting science first. Let me just say that since january the president has consistently placed politics over science and the nations Covid Response and undermined, in my opinion, the independent and integrity of our Public Health agencies and scientific experts. His words have created confusion amongst thesi American People eroding their trust in a Public Health institution and so it is Little Wonder that polling the public trust in the future, 19 vaccine has declined drastically over the past few months but that is why we have to build back the confidence of the American People as we work to ensure a safe and effective vaccine if developed. We will probably vote on an updated heroes act that was introduced yesterday and included in that is the billion dollars in funding for an evidencebased Public Awareness campaign to outline the important ofce vaccines and comt misinformation, some of which is unfortunately coming from the president. In this new bill updated heroes act there is also 20 billion in to authorize the secretary to provide grants or contracts or vaccine and Therapeutic Development 7 billion to conduct activities to enhance expand and improve Vaccine Distribution and administration and also provide language for state and local Public Health departments or procurements of vaccines and data and facility enhancements. I would also remind everyone that the heroes act as well this updated heroes act providede the treatment drugs and vaccines with no copays, similar policy that we have and cares for testing and contact racing with free testing in this space, no copay. I regret that Mitch Mcconnell and President Trump have not really stood in the way of the heroes act and the house passed back in may and i continue to fall on Mitch Mcconnell and the president coming to the table to negotiate and maybe hope springs eternal and may be before we leave this week we will have a consensus to follow up on the cares act that has this language and funding for the vaccine i just mentioned but unfortunately what we continue to see from this administrations political calculations and not science guiding its decision. Now of course the Trump Administration is attacking the potential Covid Vaccine in court because they want to strike down the Affordable Care act and theyve asked the Supreme Court to do that. The aca requires Health Insurance plans cover all recommended vaccines without costsharing for patients. If it is struck down then we will lose access to healthcare including a potential vaccine for those who lose their coverage under the aca. That to me is an outrage. Look forward to hearing from the Witnesses Today but i think the Trump Administrations actions if left unchecked would hamper the efforts of developing and administering a successful Covid Vaccinee so for that reason i hope our witnesses would provide what guardrails they hope to stay in place to keep that from happening. That is one of the main reasons i want to hear from all of you to see what you think we can do to prevent a situation where we dont have a safe and effective vaccine and people dont want to take it and all the other concerns that i have expressed so thanknk you again, madam cha. I yield back. The chair now is pleased to reckon eyes the Ranking Member, full committee, mr. Walden for five minutes. Mr. Walden. Thank you very much chairman. I appreciate you having this hearing. Americans have the confidence to any vaccine is proven to authorize u. S. Food and Drug Administration in the fda has gone through the most rigorous, independent and transparent trials testing review in the world. I in fact, the scientific and public attention focused on covid19 vaccine process is itself unprecedented. For example, fda has issued rigorous guidance for these vaccines and the need for a phase three trial as they roll 30000 participants and in addition fda has multiple existing safeguards in place to ensure science based decision in these standards for the vaccine review process and the emergency use authorization review processon and the necessy to receive meets the Gold Standard. Further there are multiple safeguards outside of the fda. Eachds of the phase three trials will be overseen by the data and safety monitoring board the dsm v. As an independent Multidisciplinary Group which includes individuals who are experienced with clinical tria trials, biostatisticians, immunologists, facts and knowledge just and virologists. The purpose is to over insure and monitor Clinical Trials to ensure participants safety and validity and integrity of the data. Addition all four companies in phase three trials are Clinical Trial protocols to provide even more transparency. There are also independent experts who serve on an fda Advisory Committee whol will scrutinize safety and efficacy data of the vaccine candidate. The evidence required for these vaccines is consistent with the fdas Gold Standard and has made the vaccine reliable, safe and effective. Separately, the u. S. Centers for Disease Control andnd preventio, cdc, Advisory Committee on immunization practices is comprised of medical and Public Health experts who are responsible for developing recommendationsme on the use of fda approved vaccines for americans. This includes how, when and to hua vaccine should be given. It is critical but lifesaving and approve Coronavirus Vaccine gets to those risks for the deadly virus without delay once thedl independent scientists hae cleared it for safety and for efficacy. However, some states now have indicated that they plan to withhold distribution of vaccines while they conduct their own unprecedented review of the data. I think that potentially risks the lives of their own citizens. It would not be the first times of these governors have done that. Such reckless actions the fdasly undermined and leaves the greater vaccine hesitate to wait and and they create public confusion within misleading information without vaccine safety and efficacy and worst of all, they will jeopardize american lives. These states have not provided any evidence of any expertise to conduct suchuc a review nor have they cited any Legal Authority to prevent their citizens from accessing a vaccine approved by the fda. Especially during the national Public Health emergency. Scientific collaboration throughout the covid19 Vaccine Research and develop and effort is an extraordinary that collaboration must continue through the complex Vaccine Distribution process, including the appropriate prioritization in all thetional logistics involved industryleading and approved or authorized vaccine. American scientists are making remarkable progress for the covid19 vaccine and experts suchsu as doctor Anthony Fauci e optimistic these efforts will lead to lifesaving vaccine and will benefit Public Health in our country and around the world. It is essential all of us involved in Public Policy in this space stick with the facts and not denigrate doctors, scientists and Public Health officials were 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 and energy and Commerce Committee republicans worked over the last several monthst to develop recommendations to address an uptick in cases for a potential second wave of covid19 infections in the u. S. This results of these efforts at least in a series working document and i asked a unanimous consent to improve the vaccine and therapeutic second wave document that we just released in july and as noted this will happen at the end of this the hearing. In addition i ask any following documents to be entered into the record. The protocols recently released bite magenta, pfizer for astrazeneca and second, the letter signed by Nine Companies developing covid19 vaccines to uphold the integrity of the scientific process and third the fda the guidance for industry for recommendations for developing covid19 vaccines with the vaccine candidate which was released in june and four, pledged by senior fda career executives to follow. [audio difficulties] i understand these documents have been shared with majority and at the parapet time that they all be entered into the record. They sound great to me. We will do it at the end of the hearing. Thank you. With that, madam chair thank you again for the hearing and i yield back the balance of my time. I think the Ranking Member. The chair asked unanimous consent that the members written Opening Statement be made a part of the record and without objection i yield into the record. I would now like to introduce our witnesses for todays hearing. Doctor Mark Mcclellan, former commission of the food and Drug Administration and founding director of [inaudible] center for health at duke university. [audio difficulties] dean of the Public Health center at the university of nebraska medical center, doctor paul director of the Vaccine Education Center at the Childrens Hospital of philadelphia and doctor gale cochair of the National Academy of sciences, engineering and Medicines Committee on equitable allocation vaccine for the Novel Coronavirus and [inaudible] dean of the school of Public Health at brown university. I want to thank all of you for joining us today and this really important hearing. I know all of you have been advised by a staff that the committee is holding an investigative hearing and when doing so we have the practice of taking testimony under oath. Do you have any objections to testifying under oath . Seen no objection let the record reflect that the witnesses have responded no. The chair then advises you to under the rules of the house and the rules of the committee you are entitled to be companied by counsel and if any of you to desire be accompanied by counsel today . Let the record reflect that the witnesses have reflected no. If you would, please raise your right hand so i may swear you in. Do you swear that the testimony you are about to give is the truth, the whole truth and nothing but the truth. Let the record reflect the witnesses have responded affirmatively and all of you are now under and subject to the penalties set forth in title 18 of the United States code. We would like now like to recognize our witnesses for five minute summary of the written statements and there is a timer on your screen that you can see and it will count down your time and turn red when you are five minutes have come to an end. I would like to first recognize you, doctor mcclellan for five minutes. Chairman, Ranking Member and members of the subcommittee and Mark Mcclellan and i previously had the privilege to serve as commissioner of the fda from 20022004 and i serve on the board of directors at johnson johnson. The development of safe and effective vaccine in conjunction with other treatments and nonmedical measures like masks and testing represents our best path for containing the moving beyond pandemic. The impact of vaccine depends on its safety and effectiveness and also on Public Confidence in the vaccine. Guided by the help providers they trust americans will need to choose to get a vaccine to protect themselves and reduce the spread to people around them. Critical to achieving the benefits of safe and effective vaccination or actions of our federal government Public Health scientists and regulators, in particular the expert staff of the fda. Fda has set the global Gold Standard on issues of medicalfe safety and effectiveness and has unparalleled experiment metric use in regulating vaccines that are safe and effective by hundreds of millions of americans. Throughout my career ive experienced the first and experience the integrity, expertise and commitment of the fda career, particularly in responding to Public Health emergency. Di the vaccine experts and the biologic center are globally respected for their decades of experience in overseeing all aspects of Vaccine Development, manufacturing and post market monitoring. I appreciate the fdas explosive commitments to the public that these processes are followed. Fdas approach to Covid Vaccine is part of a welldeveloped system of independent checks that have been put in place over decades to build a reliable and robust infrastructure for entry vaccine safety and effectiveness. There is great urgency in a pandemic in these matters given to lives being lost daily. During my time as fda commissioner we worked on a by person basis with this committee to enact fdas authority from emergency youthge authorization which has since been used and augmented based on experience at the h1n1 pandemic. The administration deserves credit for the work of operation or speed which has led to extraordinary progress in advancing multiple promising vaccines very much typically in a long and sequential parallel process including conductingud Clinical Trials at scale at the same time scaling up manufacturing. The assurance and clinical safety and effectiveness as part of these steps is imperative, including if emergency youth authorization and the supply. Fda provided Entry Researchers with infrequent guidance with this process including written guidance documents for preclinical and Clinical Development as well as safe manufacturing practices. From the white house theyve implied the fdas plan to reduce guidance on the excitations for eua of a vaccine is unnecessarily raising the bar and that is not the case. Fda standards are based on the decades of experience and with the experience and development of urgently needed countermeasures during Public Health emergency. Fda has been sharing its regular tory guidance directly withur manufacturers and researchers and guidance as reflected in the design of the largescale Clinical Trial and other Development Activities underweight now. Vaccine manufacturers are committed to following up fda guideline. Fda has been clear and public statements as recently as yesterday that its emergency youth authorization standards for vaccines are different and much higher than those for therapeutic products already on the market like convalescent plasma and are generally the same for the safety and effectiveness of other vaccines. Consequently fda required randomized Clinical Trials is requiring the trials to produce large safety databases to monitor for side effects that extend half a month or two in which most side effects typically occur in the fda has made clear that they intend to use emergency authorization to post Market Data Collection all to augment evidence of the oval on the vaccine. Congress designed the emergencyy authorization process to provide fda with exactly the flux ability to set standards that are appropriate for the different contexts that arise during the pandemic. All of these wellestablished systems for vaccines make safety and effectiveness and have kept the Covid Vaccine Development Process robust and on track. This is despite a range of wpolitical actions including proposed actions by some governors that have setgent up w and untested vaccines processes. Despite the fact that Vaccine Development continues f to follw fdas long Health Standards and guidance buried the concerns are understandable to clinical Actions Create uncertainty for the publicun that diminishes confidence in the fda and Vaccine Development. Over the years this committee has provided strong bipartisan support and resources for an effective fda and science based Development Process for products that address unmet medical needs. We need that today more than ever to avoid ending up prolonging the pandemic and all its health and economic consequences. I put the remainder of my statement, longer statement, into the record and i appreciated. Thank you. That will be done. Thank you, doctor. Next i am pleased to recognize doctor kohn for five minutes. Thank you. Ranking member, members of the subcommittee i am a physician of Infectious Disease epidemiologist at the college of Public Health at the university of nebraska medical center. I was strongly [inaudible] with response abilities for national procurement. We are currently witnessing the greatest Public Health failure in our nations history on the sluggish and shortsighted government response combined with themb disregard for scientific expertise that is undermined trust in Public Health. I am pleased to be here today to discuss my experience with preparing his planning and to reinforce that we must heed the Lessons Learned from prior Vaccination Campaigns such as the 2009 h1n1 pandemic, including addressing the challenges with trust. G i also want to remind that was 750 preventable deaths occurring every day the United States we cannot wait for a vaccine to contain this covid19 pandemic. Now, while the preliminary data is helpful the prediction of an election day covid19 vaccine has raised numerous concerns in the scientific and Vaccine Development community, as well a as among the public about trust for the vaccine. Trust of the vaccine will be as important, if not more so, than the safety and efficacy which are much easier to manage. The lessons of the 2009 h1n1 experience may be helpful as the nation undertakes the most ambitious Vaccination Campaign ever. That responsee uncovered communications, operational and policy challenges across the federal Government Regarding the distribution of vaccines. H1n1 vaccine was initially available in the United States in october 2009 for about 4 months after the who declared a pandemic but the vaccine did not become more broadly available until december n 2009 and by tht time the h1n1 had passed and many individuals were no longer gettingnd vaccinated. This diminish the credibility at all levels of government from the amount of vaccine broadly to the available did not meet expectations set by the government. In addition state leaders have poorly defined initial targets for vaccination with unexplained variation between entities and despite significant outreach efforts and the provision of free vaccines persisted with vaccination rates. Logistic challenges included 100 million auditors inrd many states reported to breakdown and pass the vaccine to efficiently two smaller vaccine sites. There are a myriad of strategic and operationalha challenges wih potential covid19 vaccines, including the probable need for two dosesbl of the same vaccine giving 2128 days apart multi joes files and complex storage requirements and others. Its going to be critical to leverage our nation to sting Public Health system and vaccines to tradition and for structure to ensure the efficient and equitable access to theseti vaccines. Planning and priorities setting at the state and local level is a must and we also need to assure the interoperability and timeliness of the numerous data systems to manage and evaluate the effectiveness of the distribution and administration thehe vaccine and monitor events. While vaccine demand will likely be the immediate issue for any potential license vaccine we must acknowledge that Public Acceptance of the covid19 vaccine is not a given. There is evidence of existing Vaccine Hesitancy even before any actual even perceived their potential convocation identified inon licensing and monitoring paired and increased vaccine uptake we must avoid the use of predictions in our messaging and provide clear consistent and factbased messages. Lessons learned from h1n1 reinforce that we need to under promise and over deliver. In conclusion, there is no guarantee that vaccine efficacy and Vaccine Coverage will be sufficient if contained the covid19 pandemic. Right now while we wait for the vaccine we have the ability to implement an evidencebased eplaybook that will reduce the number of cases and deaths and thisis will require unified locl state and federal leadership and is evidence based and uses metrics. Thank you. I will be ready to answer any questions and if you make, madam chair, include my longer testimony in the record. We will do that. Thank you very much. I would like to thank the energy and Commerce Committee for allowing me to be a part of this hearingen. My name is paul office and im attending physician and the division of Infectious Diseases at the Childrens Hospital of philadelphia and professor of pediatrics at the paramount school of medicine at the university of pennsylvania. Im also the coinventor of the Rotavirus Vaccine which was recommended by the cdc for use in all use in the United States and by the World Health Organization in 2013. 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. The American Public the language surrounding this effort is frightening. Phrases like work speed, the race for a vaccine and vaccine finalists have caused some to wonder about whether critical phases are being skipped or worse that safety guidelines are being ignored. Further the administrations politicization of science in m areas like social distancing as well as the push to approve drugs such as hydroxychloroquine have caused some to wonder whether the same low standards will be applied to covid19 vaccines. Polls have shown more than half of all americans would d choose not to receive covid19 vaccine if offered which would make it difficult to achieve heard immunity by vaccination and eventually getting control of this s pandemic. Despite these concerns im optimistic that what happened with hydroxychloroquine and convalescent plasma will not be repeated for vaccines for several reasons. The data safety monitoring board supervising covid19 vaccines have been charged by the group withholding them to the same standards of safety and efficacy that would be found for any vaccine which makes sense given most of those who inwill initially receive these vaccines will be healthy young people unlikely to die from this infection. Second, fda commissioner hahn stated in a recent oped in the journal of the American Medical Association he would quote, rely on transparent discussions by the fdas birkbeck Committee Prior to vaccine authorization. This committee is composed of researchers who are not associated with either industry or government and can be counted on to give an unvarnished appraisal of covid19 vaccines prior to approval. Third while the development of covid19 vaccines has been faster than any vaccine ever produced, one aspect of that Development Process is identical for the way vaccines have been developed in the past 70 years. Typically the phase 3 trials. Trials for covid19 vaccines are large prospective placebocontrolled trials of about 30,000 people. The science of these trials is typical. The human papilloma virus vaccine included about 30,000 participants and the pneumococcal vaccines about 35,000. As long as these phase 3 trials are allowed to proceed until theres clear statistically robust evidence at the vaccines work and are safe from the groups who wish to receive them, then they will have been held to the same standards as previous vaccines. Finally during my service on fdas vaccine Advisory Committee ive come to know that people at the fda who are involved in vaccine licensure. These are who these people , who you wouldwant them to be. Dedicated to protecting the public and the products that are unsafe or ineffective. If covid19 vaccines are released before theyre ready to be released, we will hear from these people and also hear from people like doctor Francis Collins and tony county, both of them are trusted by the public as well as many other at researchers who wouldnt stand for this. The public is nervous about these vaccines. If Health Officials decry premature release acceleration by the administration will be shortlived. While people are understandably nervous about soon to be released vaccines, i think they can take comfort in the fact that many people in supervisory positions as well as a cadre of independent academic scientists bending behind them are monitoring this process and looking out for the publics best interest. Thank you. Thank you doctor. We are now pleased to recognize doctorgail for fiveminute Opening Statements. Thank you very much and good morning to the chair of the Ranking Members and members of the subcommittee. Thank you for having us and for inviting me and my other panelists. My name is helen gale and i am testifying today in my capacity as the cochair of the National Academy committee on equitable allocation of the vaccine for the Novel Coronavirus. Ive spent 30 years in Public Health including 20 years with the centers for Disease Control n. In july, the nih and cdc at the National Academies to develop an overarching framework for Vaccine Allocation to assist policymakers and inform the work of National Health authorities and other advisory bodies in the development of national and local guidelines. On september first, our committee released a discussion grant of that framework to be able to get input to the public. The discussion draft presented Lessons Learned from otherallocation efforts , our draft allocation framework and how this framework be applied in various scenarios. Our final report will be released to the public this friday so today i will be talking only about the discussion draft. As mentioned previously this is not the first time the nation has faced allocating scarce resources during a public emergency so in delegating a draft framework for the Vaccine Allocation, our committee was informed by lessons from previous allocation efforts for vaccines as well as strategies set forth in other allocation frameworks that were being developed in the United States and around the world. Our Committee Proposed six foundational principles that informed our deliberations about allocation criteria. First, we focused on the principle of maximization of benefits and that led us to adapt an overarching framework or overarching goal of maximizing benefits through the reduction of morbidity and mortality caused by the transmission of the Novel Coronavirus. Second, the higher rates of covid19 infections and disease and death among people of color linked to the longstanding index of systemic racism in equity let us to a principle of mitigation of Health Inequities. Our third principle of equal regard directsattention to the equal worth and value of every person. The fourth visible highlighted the importance of impartiality. Our fifth principle of transparency emphasize the importance of open disclosure of the principles, criteria and priority groups that determined our allocation framework and who would get the vaccine sooner than others. And the final principle is that all decisions must be evidencebased. The to determine the population groups that comprise each allocation they are committee used for riskbased criteria to characterize population groups by the risk faced by their specific members each of these groups. The risk categories include the risk of acquiring or transmitting the infection , the risk of severe morbidity and mortality and the rest of societal impact. Our committee opposed for main approaches to Vaccine Allocation. Within the population groups included in each of these four phases are Committee Recommended that Vaccine Access should be prioritized by geographic areas identified as vulnerable through cdcs social Vulnerability Index. We have four phases, thefirst included a jumpstart base. And that included Frontline Health workers, classified by professional titles but by their actual risk of exposure and it also included first responders. They jumpstart phases followed by a phase i e which includes older adults living in cognitive settings, individuals with high risk underlying conditions. That were also included in this phase. The second phase was an extension of t vaccine supply would allow for immunization of additional individuals with underlying conditions within increased risk, all older adults, not identified in the first phase and then also teachers and school staff. People who areincarcerated or detained or living in group homes. Or homeless shelters or other aggregate settings and additionally, the first group of critical workers are in industries essential to the functioning of society rsand high risk of exposure. All ghthose were included in thesecond phase. The third arphase when vaccine supply would become widely available for allowed for broader immunization of workers in our important to restoring full Economic Activity and broad children and young adults and finally once vaccine supply became more broadly available in phase 4, vaccines would become available to any of those were not part of the first three phases. While uncertainty about the vaccine existed, our committee approached our Branch Framework with the best Available Evidence today understanding this would continue to evolve. So with that i just want to thank you for the opportunity to testify. This is only a brief summary of our discussion graphs. The complete and final report will be released this friday, october 10 and that report will in addition to having our final allocation framework will also discuss topics related to implementation, risk communication, tCommunity Engagement, Vaccine Acceptance and global consideration. Thank you and im happy to answerquestions. Thank you doctor, i look forward to seeing your report on friday. Doctor shots i recognize you for five minutes for Opening Statements. Iq chairwoman and members of the committee reared is my honor to be here with you today. We are nine months into the worst pandemic in a century. More than 1 Million People around the world and 200,000 americans have succumbed. While weveidentified a series of Public Health measures and therapies that if used effectively can keep the disease at bay , in order to bring the pandemicunder control , we will need safe and effective vaccines. While it usually takes years, often decades to build vaccine, unprecedented collaboration among the Global Scientific Community means we have multiple candidates in phase 3 trials just nine months after we identified the virus. This is an incredible virus. Heres 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 dont fumble the ball. We have seen large declines in americans willingness to get the vaccine and if we fumbled the ball, the cost to our lives and to our treasuries will be enormous so as has already been stated, here is the key point. We need to ensure we have vaccines that are safe and effective and perceived to be so by the American People so why are americans worried . Theyre worried because of the politicization of the agencies like the fda. Whether it was the emergency use authorization of hydroxychloroquine or the hyping of convalescent plasma, physicians and the American People worry about the integrity of the fda decisionmaking process. A decision to issue an eu a for a vaccine must be based on scientific timetables, not on political ones. And the need has grown recently as the pfizer ceo has repeatedly suggested that hes moving to get their vaccine out before the election. This on top of the landscape of vocal science denying antifactors has created a dangerous situation that has allowed to fester, could cause loss loss of faith in vaccines for years. We must not let this happen. I believe there are three things we must do. First, we might less must let them specify scientific standards drivewhether a vaccine receives eua or not. I just put our guidance last week about the requisite followup period and the impact of any vaccine on disease severity. These are right and they are at a minimum and we must ensure that we let fda use their standards for an eua approval. Second we need a lot more transparency in the process. I was heartened to see Vaccine Companies make their protocols public we need more transparency about safety signals and their trials and how they are addressing them. Unprecedented times like these call for unprecedented transparency. And finally, it is critical that when eua is issued, we should directly from a great career scientist at the agency, this will ensure for this will assure the American People science is driving this process, not politics. These are critical steps but they alone will not be enough. We need a strong communication plan that engages with critical and Public Health leaders, religious leaders and others about the process. Americans will turn to these individuals. Next, we need a plan for a 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 are able to get tested on a regular basis but regular testing is not available for schoolteachers and first responders. We need to ensure vaccines are available for all of us, not just those who are wellconnected and finally we need to limit all financial barriers to getting vaccinated. One in three americans report they will skip the vaccine because of financial concerns. We cant let this be the case. 20 20 has been a hard year for all. 2021 can be better. In order to get some semblance of a new normal we need a vast majority of americans to get vaccinated with a safe and effective vaccine area Vaccine Development process so far has been done with great scientificcredibility. Its now time to let science finished the job and lets use good science indication to help people understand the integrity of the process and lets eliminate financial barriers and implement distribution plans to ensure we can turn vaccines into vaccinations. If we do all that we can bring the pandemic under control, heal our economy and let americans get back to new lives. Thank you so much, thank you to all our panelists for your excellent testimony. Now is time for the members to ask questions and the chair will recognize herself for five minutes we had so when i was watchingthe debate last night , i suddenly realized that the president who has been politicizing this whole vaccine approval pr process is actually trying to blame the democrats for that and i dont think it should obe politicized by anybody. All of our panelists today have defined that we need to rely on the scientific integrity of our agencies and our scientists. I believe so strongly in that and i believe thatswhat we need to do. So thats the impetus for my questioning because i think that the career scientist have been systematically undermined from months with both the hydroxychloroquine and emergency use authorization approval and then of course the plasma emergency use approval. So i want to ask and what ive been asking all of the experts i talk to them and i keep hearing about these guardrails to prevent the pressure, the undue pressure thats been put on agency by the president for these other euas two used in a vaccine approval and what i hear from everybody is we have these guardrails reared doctor off it in your testimony you talked about tseveral different guardrails to data safety monitoring board, the fdas the rb, pac and other systems for review and approval of these vaccines that you and plus of course the wonderful fda and nih scientists. Do you think that these will be sufficient to prevent undue pressure from coming on agency or even s. An abrogation of the process and just simple ordering of approval by the president and the administration . Yes, and theres a third thing. The Advisory Committee once a vaccine is licensed or approved will independently review data and independently make a decision about how they recommend giving a vaccine. I like you im worried about the politicization of science but i do think that it would be hard topoliticize this. I think hydroxychloroquine. Let me stop you because i want to ask other panelists. So you feel confident inthe guardrails we put in place for the vaccine. And what do you think of doctor mcclellan. Do you think these guardrails are sufficient to stop undue politicization . I do and not just me but yesterday, seven former fda commissioners over the last three decades, five administrations all said the same thing. This is a very robust process that is hard for any political influence to disrupt what we are concerned about is the impact of political influence on confidence as weve been talking about. Thats why were having this hearing today. And i believe there was an article in the washington that this morning about statement. And its titled seven former fda commissioners, the trumpet ministration is undermining the credibility of the fda and i will ask Esther Guthrie at the end of this hearing, ask you that for this in the record. What about our other witnesses, doctor con, do you think that we have sufficient guardrails in place to stop undue politicization of this process . Thank you chairman, ithink the guardrails are quite excellent. Lsi think the guardrails are quite excellent but i think we all need to remember those e guardrails not work so far where we had looked at cdc guidance for example. Whether we test asymptomatic individuals, what is the guidance for children in schools. So theres a number of guidelines from cdc have not been subject to those guardrails. What you think we cando to protocols t those are followed briefly. Even for cdc i think we need to ensure the same set of guidelines for public gu health in general. Im not sure public differentiates sba from Everything Else theyre reading about interms of the politicization of science. Doctor shaw, whats your view of this, you think the guardrails that were outlined by doctor off it are sufficient . Guardrails are strong and i agree with all of my fellow Panel Members but the problem is some of the signaling for instance, doctor con has been public in saying he doesnt have to listen to has Advisory Committee is true but that isnt helpful and it is also unhelpful and we know that he has succumbed under pressure and so while his words are reassuring, what i would like is much greater clarity scientists will get to drivethis process. At the fda chief wont override the Advisory Committees recommendations. If all of that happens i will feel more comfortable with that the guardrails will hold up. I think you have bipartisan agreement with that area i think everybody agrees we need to make strong statements all of the scientific principles will be followed and that this will be a rigorous debate. Punishment the i recognize you for fiveminutes. Thank you very much for the recognition and doctor, i want to thank you for your testimony. And also for what you just said a few minutes ago you really have a lot of confidence in the fda, the fda scientists and Advisory Committee, independent Data Monitoring Committee that have strong guardrails in place and a couple other witnesses seem to say they are in place but we still need to i dont know, it could go off rails i guess and im concerned that were going to say things and not have people confident about vaccines. We already had a hearing about Vaccine Hesitancy and its something that i hethink doctor off it said the scientists that scream and yell at Something Like that happen so we need to make sure people can have confidence when a safe and effective vaccine is approved , it will be safe and effective so hopefully we can keep our runner going in that direction but doctor mclennan , id like to ask you if the vaccine manufacturers applied for an emergency authorization prior to submitting a biologicslicense application , what kind of extensive data with the companies have to provide to the fda about the safety and performance of the vaccines and how similar hathough with those packages be submitted under the approval process did you get all that . I think so, i had a chance to talk with doctor peter mark last night where he reiterated he expects the evidence or safe effectiveness for the vaccine approved under an eua to be very similar to that for full approval. At full approval includes a lot of additional documentation, thousands of 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 a context that we are concerned about here. And to make sure all of this is not only reviewed fully by the fda as doctor off it said , there will be an Advisory Committee meeting for each vaccine, each vaccine that comes forward with an emergency use application for the fda to write a written review for discussion with these expert independent advisers about whether the vaccine standards are being met and i have full trust not only in the fda right people like doctor off it had been doing this for years have tremendous amount of experience with vaccine safety including or vaccines to use in infants and after that, fda will write a written asis or its decision and then even before it goes to another incident review by the cdcs immunization practices committee. So those are a lot of steps that people should be looking for in terms of transparency and independent regulatory expertise. Expertise, all coming to bear to make sure we have the right evidence on face safe effectiveness. My guess is it will be transparent if we dont follow those pathways. Can you explain why the ea you for vaccines would be different than the dau for therapeutics . Its a very different context and as you know from working on these issues over the years, the emergency youth authorization was limited to give fda flex ability to respond as needed in a Public Health emergency area so as you mentioned earlier , about the totality of the evidence in a particular context. So in the context like convalescent plasma where the treatments been around for 100 years and used in many different infections, its on the market now and its being used in thousands of sick patients, with no significant evidence of safety side effects. We dont have good evidence on benefits and thats where i think some of the Political Leadership got it wrong when they were characterizing what the fda career staff decision was they made it sound like it was a clear beneficial treatment area but were talking about is a treatment thats already being used for a people who are hospitalized that the evidence shows isnot harmful. And that kind of expanded access is something that fda has a tradition of doing for a net medical needs and people who are very high risk while evidence is being developed area i hope we get a Clinical Trial done more comprehensively in answer to this question is a very, very different context than a new vaccine used in people who are not sick or trying to keep well. Finally a few seconds but can you explain why ea you or can you, what the fdas guidance is for a vaccine that gives you confidence that it will be strong times by any decision made or than any safeguardsoutside of the fda to make sure you have confidence. In 15 seconds while youre confident that we have a safe and effective vaccine. To cover that, theres a whole checklist. I think we talked about a public event and writings that will be coming from the fda staff before the decision is made area lets inform the public about that. And as you pointed out earlier all the vaccine ar manufacturers have said they are going to follow this process and even though this fda written guidance on eua hasnt been released, believe me, all the manufacturers know whats in it and doctor marks in the fda fda staff reiterated that again publicly what all is in so weve also got a lot of independent experts, other agencies create a very robust process its been developed over decades because vaccine safety is so important. This is i appreciate it, i feel back area. Thank you so much and the chair recognizes thechairman of the full committee for five minutes. If after months of the trumpet ministration undermining science, now we have a number of polls that show that the majority of americans have reservations about getting a vaccine. Once it becomes available. So let me start with doctor con, what do you believe are the consequences of this repeated subversion of science and attacks on the Public Health agencies . Thank you chairman. There heis no doubt that over the last eight months weve undermined a Health Science in the United States througha combination of i would say three or four things. One is misinformation and manipulation of science. The second is elevation of personal liberty about our total responsibility. And the third is equating Public Health science with having enough hospital beds, ventilators and body bags. And for, would be probably discounting the value of a life with 200,000 preventable plus deaths in america. And the numerous now documented evidence of manipulation of science so theres no doubt that from a public perspective its easy to see why anything coming out of the administration could be mistrusted. So its fortunate as in the prior conversation theres a lot of independent review of vaccines but this politicization really has undermined Public Health science in america. You have expressed your disappointment in the nations Pandemic Response. You describe it as among the worst in the world. Thats a quote as the trumpet ministration politicization of sciencecontributed to this failed response and what do you think the impact of that has been. So a couple of quick things, first of all theres no doubt, just look at the data, if you look at the numbers thatdoctor county said last week, we are among the worst performance in the world , certainly the worst performer. We have the best Public Health scientific agencies in the world. Cdc and fda are Gold Standard for everybody else in the world. Unfortunately we have not let them function in a way we need them to function so there is no question i think on anybodys mind, certainly i doubt on anybody in this panel about the integrity and capability of the great scientists at both of these agencies. A problem has been that their voices have not always won the day and that their voices have often been overridden and subverted by a political process that is unprecedented and had never been done before and that has substantially hampered our response, made it much harder for us to get things under control and unfortunately has led to a lot of people dying unnecessarily. Doctor mcclellan you mentioned you joined six other former fda commissioners in this oped in the Washington Post raising concerns over the trumpetministrations actions. Not only undermining credibility but eroding Public Confidence. You believe thatif left alone to do their job , but the career staff could be trusted to let science guide the decisions whetherfor the vaccine or new test or treatment. Ci i do believe so. And as we said in that oped, despite recent clinical actions we have confidence in the integrity of the scientific work of the fda staff and this unlike say tdc just writing a guidance and having them blocked, this is a major process with a lot of regulatory toversight, all of this independent scientific engagement from advisory bodies. Actions including enrolling and conducting very large Clinical Trials eye on multiple companies. This is not an easy process to disrupt just because somebody says something about it. It does undermine confidence though. What can we do to restore trust in the nations Pandemic Response . You heard some of the things that were put in this new updated euros bill. The experts, the scientists are in place, what do we need to get the president and his cronies out of the way or to fix this that we can go back to having the fda do its job. So first of all, i have said this area i think all political leaders need to stop talking about things like timelines. Politicians dont know what the timeline is and unfortunately the political appointees have not been upholding either so what i have said is if the career scientists of the fda or the ones that the cdc get to do their job and we hear from them directly that they believe that a process has high integrity, i think that would be enormously helpful and would go a long way toward offering g assurance to the American People that this is a process with integrity. I dont believe we need whole new set of independent bodies at state or other levels so we got independent bodies, if the one that Doctor Officeis on , if that Committee Comes out and says evidence is strong and clear i think the American People will have, will feel assurance by that but we need to make sure their words and voices carry the day and not those of political leaders h. Thank you madam chair. Thank you so much. The chair is pleased to recognize the Ranking Member of the full committee , mister walden. Thank you again madam chair for this hearing and thanks to our witnesses for your fine testimony read doctor mcclellan some state officials as you know expressing skepticism about federal reviews of potential vaccines indicating their state plan to conduct their own independent review of the Clinical Trial data before determining a vaccine. Despite an approval or authorization on the fda. You believe such a review by states would be necessary, has been done before, are they quick to do this, did they do this on anything else that the fda approves the you think this would actually slow down access to an fda approved vaccine that could save lives. I just like doctor john express i have concerns about. We just talked about how extensive and developed and how much resources go into that fdas process. A thprocess that you all have supported through your limitation on bipartisan basis of continued efforts to strengthen and improve the federal food writing cosmetics act which is meant to provide a high level of confidence about safety and effectiveness of medical products in general vaccines in particular , it is a huge undertaking with a lot of expertise. Experience, loculture. It is hard to see what a sstate body of some kind could add to that. I understand where the impulse is coming from. Maybe if the what would the group would do is just go through this kind of checklist. It is all the things we talked about today, are they actually happening , are we hearing from the career staff is the process being followed mark maybe that could improve confidence but its hard to see how to replicate anything like this national Gold Standard system that weve developed. I would say ive been through a lot of closeddoor discussions with the hhs with, nih, doctor county, doctor con, doctorredfield. They all say youre going to follow the standards. We are not going to yield in any way read it all going to be about the science and all going to be about the data and are there independent scientific review boards set up outside of the fda . To look at these things, to look at the data . It might be technically encompassed within fda and cdc but are they separate independent and i would think people of great integrity and scientific capability mark. Not just fda but the whole system of regulatory oversight, scientific isexpertise. Doctor often talked about how the data safety monitoring board which nih is generally involved in for the trials and nih expertise, as you just mentioned. Cdc expertise and cdc drawn in a whole of independent experts through their Advisory Committee on immunization practices which will also provide a review as part of this wellestablished process. It is a system like no other in the world and we are very o lucky to have it in the United States. We are hearing internationally that russia has a vaccine there ready to push out and china. Tell me how their systemswork in contrast to ours. Mister Ranking Member, in china and russia there are people getting vaccines now that have not been through anything like the process weve described. These large socalled phase 3 trials approved and demonstrated a vaccine reduces number of infections. It reduces severe infections, they have these very large databases, tens of thousands of people whove been followed after they get the vaccine that have the fdas authority on top of that to set up additional monitoring on the people who are first to get the vaccines. Our first responders, our Health Professionals and others who are such big risk because of the ongoing pandemic. Its very different. Its a system that really is setting standards for the world. Mister con, do you want to weighin on these matters . I saw your head nodding there like you wanted to add in. I wanted to add into doctor mcclellans comments. In russia the vaccine was licensed with less than 100 people who had been vaccinated in a phase i trial read at impossible in the United States. Do you agree there are these independent organizations that are comprised of people who have the scientific ability that are going to bepushed around if you will buy anybody . Theres no doubt about the integrity of the people for example in the h sip. Theres no doubt about that. Its really an issue of confidence and how do we ensure that when these vaccines are available, the checklists have completely been followed. Thank you very much to all of you and madam chair ideal back. The chair recognizes congresswoman jackowski. I first want to welcome doctor gail who in addition to her role today i know as head of the chicagocommunity trust so welcome today. I am so glad that my colleagues and i have passed legislation vaccines to most americans atno cost. But we must extend that protection to the uninsured people as well. A vaccine can only be as effective if americans and people around the world can afford to take it. But lets be honest about it. Thats because people dont have to pay when they receive the vaccine. Doesnt mean that a vaccine is free. Us taxpayers have already paid drDrug Companies over 10 billion for vaccines, for Vaccine Research and development. And thats through operation works the. In the years to come, public plans like medicare and medicaid and the va etc. Will all the harm by the Drug Companies if they are allowed to use monopolize power to charge whatever they want. And lets be clear that if the republicans and the president of the United States has their way to end the Affordable Care act the Supreme Court, then the aca right now prohibits cost sharing for Preventative Services and that would be eliminated. And that means that all americans will face copays for all vaccines including covid19 vaccines once the Public Health emergency is over and finally i just want to say that roxanne just issued a report that quote, wealthy nations represent just 13 percent, representing just 13 percent of the World Population have already bought over 50 percent of future vaccines. So i would like to ask doctor job two questions. First, to ensure equitable access, do you believe the federal government should pharmaceutical companies to sell a taxpayerfunded covid19 vaccine at a transparent, fair and reasonable price. Let me start off with that question, its absolutely necessary for the Us Government. Its been a major investor in these efforts is maternal, whether its companies that are part of the operation works see the Us Government needs to make sure that the vaccines do so at a fair price and of course the big question would be what is a fair price, what a reasonable price. I wanted one of the points id like tomake is the vaccines are going to be needed by billions of people around the world. So you need a large margin on every vaccine tostill get plenty of buffer it is absolutely essential to vaccine the affordable , could be affordable to americans, to taxpayers also affordable to the rest of the world. I want to thank you so much for mentioning that in your Opening Statement. And i appreciate your mentioning because when we talk about access, cost is so important. And now it was really mysecond question , is if we can, we as americans can really be protected if other countries cant afford the vaccine. I wonder if you want to elaborate on that amore , especially Oxfam Research was just announced. Absolutely congresswoman area if your only goal is to protect the American People, lets say we didnt care about other people in the world but of course we as americans do if our only goal is to protect the American People we would want to make sure that much of the world is vaccinated because if there continues to be large outbreaks in other places, those outbreaks see their way here. Nobody believes that any vaccine will be 100 percent effective and 100 percent of americans will take it so there will still be vulnerable americans and part of protecting america is making sure thereis widespread vaccination all over the world. Thank you so much and i feel that. I think the general lady in the chair recognizesmister mckinley or five minutes. Thank you maam chairman. Last nights president ial debate truly was a bottle and an embarrassment to the American People. But now, the democrat leadership and liberal media are expressing similar disrespect. The integrity of our Scientific Community by sowing the seeds of doubt about the efficacy, safety vaccine and interjecting politics into this. Ever since the virus cropped up theres been arallying cry to get a vaccine as soon as possible. President trump instituted operation works need to do just that and Congress Overwhelmingly offered to fund the program but now just as we are on the cost of having a viable vaccine and say, democratic leadership wants to move thegoalpost once again to slow down the process. The speed is still of the essence. And my question is what part of operation works see they understand. Look, scientists dont get through to do who the president is or who controls the house or the senate. Using the same protocol theyve been using for decades, these scientists simply want to create a vaccine so people can confidently return to work and our schools. The public has been clamoring for a vaccine. Now the democrat leadership once you perpetuate a conspiracy theories only confuse the American Public more area its time. We cant we just stop this foolishness and put aside our political grandstanding . Lets trust the scientists, our career scientists and the fda read it to do their jobs. Now my question is to mcclellan if i could doctor mcclellan, do you think politics is motivating the democrat leadership to question the efficacy of the drug even before its finished litigant trials. Theres certainly a lot of Politics Around this issue and the coronavirus response. I would just say a couple of things. One is i agree with you about the value of operation works see for making the Vaccine Development process. And leading to the potential for actually having a vaccine by the end of the year and maybe in widespread use next year it can potentially have such a big impact on the pandemic and our health and our economic wellbeing. If i could go back again. These seeds of mistrust and the misinformation from the democrat leadership are alarming. A trust as you pointed out here, public trust in this vaccine is dropped by nearly 80 percent just the last couple of months. So reasonable to assume that this mistrust of a vaccine that permeate the mistrust of others vaccine that we need . It certainly is and thats why this hearing and i think the bipartisan support that this committee has all over the years fairly provided for the scientific process and fda and i htc is so important right now and i hope together you all can help restore confidence in the public and what i think is very Vaccine Development and oversight process. Again, let me reinforce again what you were saying earlier. You think the guardrails are there in place to be able to provide this and this is involving politics and i heard you say yes, that politics are involved, isnt she because if the guardrails are in place and we demonstrate that, the only reason i think this is being raised at this point is because of an election process up infive weeks. I like to get the politics out of this and i appreciate the bipartisan interest on the committee in making that happen. For helping to make that happen. Shame on people for making this partisan area this is a thing we should resolve. We had a mission to get this vaccine approved and people want to play politics, i think all this panel knows that this is politics really raw, unmitigated s. Politics. I you very much and i the balance of my time. The chair recognizes representative kennedy for five minutes. Document chair thanks for being here thank you for convening this important era. Participants in the has been a concern long before. Its been a longstanding system that targets peoples color and i think to political trials, unsurprising there would be hesitancy in those communities to participate in now political trials. Given increased on data on the impact of covid19 on communities of color is more important than ever that we insure diverse participation in Clinical Trials and the trust in a vaccine cwithin those communities. Im concerned by statements from some companies researching vaccines that are struggling to recruit participants in a Clinical Trial is on them to try to right the wrongs of the past and work and engage communities and people with other values and i want to start with you, i know youve been involved in numerous Clinical Trials. From what youve seen all the true Clinical Trial minus with enough information about the safety of a vaccine on populations. Thats certainly the goal. I know that one of the companies slowedup because they want to make sure they had gotten adequate representation , one doesnt expect that youre going to have critical differences in terms of safety based on gender, raceor background. What you could obviously have differences regarding 80. People who are older may not respond as well to certain vaccines as other so i think that certainly is the goal because if youre going to go to people and youre going to say you need to get this we have to be able to say you are being represented anytrials , otherwise peoplevaccine is a. Ng im 65, im not going to get any vaccine that hasnt been adequately tested for people in my age group. The same is true for ethnic backgrounds or or racial minorities. Thank you doctor gail, one of the consequences , what are the consequences of not adequately, were going to have an adequate representation of diverse populations amongst file participants and what should the government be doing to address. Thank you for that and obviously this has been a tenant that has disproportionately impacted people of color as you mentioned and as Doctor Office also mentioned. So that there can be conflicts in these trials that have looked at this in populations that are reflected by this pandemic and i think when we talked a lot about the guardrails within the federal government , its clearly in their interest to have the overarching trust in the development of the vaccine but it also means partnerships beyond the federal government which trusted institutions, with hearings, all of that needs to happen in order to build that kind of confidence and theres alot that can be done to make these trials much more accessible to communities of color. Where the trials are done, what doctors offices participate, what medical institutions are so i think theres a lot more that can be done to make sure that the trials are done in a way that are accessible to the population being most hardhit by this pandemic. Doctor gail, thank you and isaw you nodding and i wanted to get your thoughts on this. Also from somebody down the street from hoyou in massachusetts, thank you for your incredible work and your outspokenness on these issues but speaking about potential confidence concern among communities of color, given the level of mistrust among people of color it surprisingly given the history of structural racism, so briefly, what more do you believe needs to be done to ensure any future vaccine will be safe, effective and trusted. Yes congressman, again thankyou for being my representative. So very quickly i will say that building on what doctor gail said, its absolutely critical that we engage Community Leaders or engage religious leaders. First of all, bleeding what doctor offit said about first steps, thats going to require a lot of work even after that, building up confidence in communities of color is going to require engaging leaders. Trusted voices in those communities and working with them, theyre not going to give anybody unless they are confident that their communities have been were represented and this is beneficial to them though theres a whole strategy here is necessary. W this is not a we show up one day, knock on the door and say we have a vaccine area weve got to take a proactive approach. On theres a lot to build and this doesnt have to start from scratch. We know a lot about our leaders and about the institutions that are trusted in communities of color and we just need to build on some of those things and make it a priority and the intentional about it. Iq, doctor conrad i had a brilliant question for you too but unfortunately im out of breath so ill let you go but i will yield back the negative time i have. The chair recognizes Mister Griffith for five minutes. Document chair building on those questions , doctor offit, you indicated to miss her kennedy when he was asking questions that one company at slow down there process in order to get a diverse Demographic Group next. Can you tell us that company was austin mark. And i just thought it was interesting and i have not heard that so i appreciate that information. Also as you and doctor mcclellan, astrazenecas Clinical Trialwas put on hold. Do join adverse event occurring in one of its enrollees. The trials have resumedand the United Kingdom , brazil and south africa. Excuse me. But to my knowledge the trials still caused in the United States, would you agree that this action taken by the fda, excuse me. Signals a commitment to safety not rushing the Clinical Trial process. I think first of all, the answer to the astrazeneca trial in the United Kingdom was put onprotocol twice, once in july and the second in september. So when you do that, theres, because theres so many investigators involved always be known by the public. The problem then becomes you dont really know the details because confidentiality precludes you from knowing those details and i talked to the head of the data safety board in the United Kingdom about this and he cant give me the details and its very frustrating for all of us because we think we know what those two cases were but we dont really we also know that the uk regulators have now taken that political hold off because they presumably thought this disassociation was coincidental and not causal that hasnt happened here and we dont know why the atdecision was made in one place or the other place and thats part of the frustration of all this. When people talk about transparency the fact of the matter is cant really be transparent about these cases because of confidentiality issues so its like driving in boston youre bound to have an accident. Doctor mcclellan. Just to add to that, i think its also a reminder that ,this is scientific process is very much in process and as you said, the fda is right on top of us watching closely before any one gets broad access to this vaccine, there will be a public opportunity through that Advisory Committee to go over this and any other significant safety issues that have, during the Clinical Trial and the chance for people like paul and i know he wants to give that information now but you will get a chance before there is any actual decision about this vaccine and this is the way it goes with Vaccine Development. Things happen, they need to be put into context of the overall trial and all the rules and safeguards including blinding and confidentiality and that will happen before on any decision that impacting it. Let me shift gears because i see the clock ticking. Doctor offit there was an oped in the New York Times in which doctor peter oshi and eric depaul expressed concerns about Clinical Trials through the vaccine stating according to the protocol for their studies which they released last week a vaccine could meet the companys benchmark for success if it lowered the risk of mild covid19 but was not shown to reduce risk of that disease or the risk of hospitalization admissions to the intensive care unit or get. To say a vaccine works should mean most people know no longer run the risk of getting sick. Not what these trials will determine. Do you agree with those concerns and either way tell me why. I dont agree. If you look at the Natural History of people who are infected with sars coded to but they have moderate to serious disease the first time there and affected, they get a second infection and its much more mild. Thats true with the virus and was also true with the Rotavirus Vaccine. I think theyre wrong, its much hiharder to prevent a synthetic infection and milder somatic infection and if you can effect that youre much likely to prevent disease so i think thats not really the history of the Vaccine Department soi think theyre wrong. Since i already had it what youre saying is if iget again it will be mild. Thats what you want, we do want to see when you develop a vaccine is make sure that natural infections can be protective against challenge and then you know theres hope for a vaccine when you see that usually all you care about is you can be protected against moderate to severe disease because that keeps you out of the hospital and out of the more. Its not usually the case when youre also prevented against having mild and if you lookat animal model studies , and can protect lower respiratory disease, i. E. Ammonia but you dont really protect against dd shedding which is to say a symptomatic infection so i dont think that oped piece was just wrong area. Roi go back madam chair, my time is up. We have mister ruiz. Hes next in order. Mysteries, you are recognized for five minutes. Thank you so much. I really appreciate this hearing. It is so vital that people have confidence in thescience of the development of the vaccine. As this pandemic continues to ravage our community, we have seen repeatedly that certain populations remain at high risk for contracting dying from covid19. This includes high risk essential workers, people of color, the elderly d and individuals with preexisting conditions. I know we all wish that there would be enough vaccine for everyone as soon as one is identified but then that just will not be the case. In fact some experts like cdc director Robert Redfield say it will be mid to late 2021 at the earliest for the us is widely immunized. Once the first vaccine is approved, things are going to move fast. And that vaccine will be treated immediately. So it is imperative that we finalize the tradition plans now that prioritize the most vulnerable work goes those at highest risk and the most vulnerable of those at highest risk means those who are most likely highest risk to get infected and at highest risk of dying from covid19. So these vaccines cant just go to the highest bidder. They have to have that public approach to save as many lives and get through this pandemic as quickly as possible. Furthermore, workers have been mentioned as a difference between highrisk essential workers, people who work in the form field, Grocery Stores versus younger affluent people can work from c home and have their own room to work on and be physically distanced from everybody else. Recognizing the final report would not beth relieved to this friday, how did the committee showid these disproportionate effects on minorities and is a risk for essential workers, high risk versus those who can self isolate and work from home and dont have underlying illnesses . Thank you. As the move probably is an overarching guidelines for these allocations, as you mentioned, one of our principles and the report was a mitigation of health and equity. We felt very strongly africanamerican and Indigenous People identified directly and how they categories is highrisk versus low risk. In the full report, y in the full report, youll see a lot of discussion on this. We try to use the Vulnerability Index as well as categories including highrisk critical workers as a way of getting at the issues because its not because youre black or brown that you arere at risk, it is because of the social economic Historical Impact on health as a result of racism and inequity so what we tried to do in our tears, our faces is address those issues and by using the social Vulnerability Index which looks at minorities status, household crowding and otherer issues put people ate risk by using that as a guide across the different phases saying you should prioritize the geographic areas. Recommendations to have measures if the principles are being followed . Our role is to do these studies, we did it at the request of the cdc but we expect they will look at these recommendations i would suggest their. Recommendation is any Public Health experts 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 communities to see if these systems are being followed because the system left out these communities and rendered them high riskig of getting infected and dying to begin wi with. I yield back. The chair recognizes ms. Brooks for five minutes. Q to all of our panelists, i completely agree with, i believe it was doctor mcclellan who said its critically important to help restore and make sure theres trust in the vaccine so i want to talk with you about the fact that we have the same candidates in the phase three Clinical Trials, weve already heard they recently released their vaccine protocols that the companies have contain details about how the participants are being selected and monitored and conditions under which the trial could be stopped early if there were problems and the evidence researchers will used to determine whether people who got the vaccines were protected from covid19 so i think it is unprecedented the companies are making these disclosures that this in the process, how does this level of transparency help the experts but more importantly, the public and i think that is what we are most concerned about, it is the publics confidence in thein safety and any additionalnc information should these companies disclose about their Clinical Trials or what should the companies be doing to increase Americans Trust in the covid19 vaccine process . I think the company has done a couple things that are unusual. First, moree transparency than generally has been the case, that is exactly their plan, they are in the process of executing that now. We talked about earlier in extraordinary written letter from all Companies Involved in these Vaccine Development, stating that they are firmly going to adhere to the fda processes so those are really important and i know now people care so much aboutno what is actually happening in these files. We talked about before, there will be things we wont know for sure for little while, the events happening in trials related to the vaccine, what do they really mean . When you get some of the transparency, creates opportunity for confusion. Ti some of the studies as is usually the case has some checks along thehe way by the independt expert, data safety monitoring board that nah is involved with and those may show the vaccine is working wayay better than people expected. It could lead to the trial coming to an earlier conclusion at least in terms of leading to a proposal to thepr fda and thas been tied up in discussion around could a vaccine happen before the election . Its very, very unlikely, technically possible if there is an absolute homerun, which i dont think weve seen evidence of yet bute. The trials are stil ongoing so it is challenging through this process to make sure people get transparency about the process but recognize we dont have answers for these questions yet and we need to take the time as we talked about for the fda scientific review to happen on any emergency use proposal for to be presented with fda comments and review to that independent Oversight Group before we reach any conclusions. The more we keep the politics out, the better. Thank you. Very quickly, we are so concerned about season, children not getting vaccines right now, Vaccine Hesitancy happening not just Covid Vaccines but other trials of vaccines that we are seeing a decrease in the numbe numbers. What are your recommendations for how we implement a better strategy and making sure theirr tracking flu and covid and also getting children, making sure to continue to be vaccinated . Doctor gail. We need to build on the existing programs we have. We have such a strong system for childhood vaccinations that it needs to be continued to be strengthened. Also, the other questions on the panelists, we got to restore the trust and confidence thats been eroded in vaccines so i think those two things to me are essential. The systems that we know work, get the right information out and continue to build on the messages of why it makes a difference to have children vaccinated and build on those systems we knowan work. Fifteen seconds. Initially what happened was because of the pandemic, as a dramatic decrease in childhood immunizations, reported, that started to come up so i think now people are more comfortable going to the doctors office. We need to make sure we get a flu vaccine next winter because of this pandemic. Thank you. I got my flu vaccine. Thank you. I yield back. Recognize for five minutes. Thank you for this hearing. Yes, this is bipartisan, i got my flu vaccine as well. We areci not trying to politici, the problem is the president of the u. S. Has politicize this vaccine, coming just weeks before an election and we owe to the American People to explain the process in the system and transparency in the hopes that one of these will double vaccine candidates would be proven safe and effective but that will only be half the battle. Once we have an approved vaccine, we face a formidable challenge, to shooting hundreds of millions of doses around the country. This is an unprecedented effort and we need to start operations right now. What are some of the essential lessons from past Vaccination Programs such as h1n1 pandemic regarding masturbation of the novel vaccine . In v. As i have stated in my testimony, i think it starts with appropriateat messaging so under promise, overdeliver, have excellent planning at all levels, local, national and state level travel and territory level, we know theres not enough vaccines the most is released. That needs to be clear up front and the needs to be part of the planning needs to deal with the logistics. This will be extremely difficult logistically, unlike the h1n1 pandemic in 2009. In the end, there was only a need for one. In this case, you need to of the exact same vaccine. Twentyone to 28 days apart, which will be problematic as complex report requirements with these vaccines and depending on the size of the orders, they may need to be split up and sent to rural areas and we talk about mass vaccination but we need to be careful about the word mass because during a pandemic, you want hundreds of people gathered together because its a good way to infect them as opposed to protecting them and we would like to keep that apart. Infection, protection so its going to be significant challenges throughout the system and i could even get into the data systems. I just want to ask youas further about one of the challenges with the Vaccination Programm is the data systems to track distribution and schedule immunizations especially if they need to separate doses. How important is this aspect, what should congress do to ensure we have good data on a Vaccination Program . How we strengthen these four or five systems, they will have to Work Together in terms of faxing tracking within the state, the vaccine efforts to prevent systems, how do you make sure they are working, robust, interoperable and computed it in real time needed to ensure that not just where the vaccine is distributed but getting into peoples arms and what the side effects are. That will be critical going back to doctor and others comments about equity to make sure as vaccine is getting out, we are doing the distribution and thats only determined by data. Existing infrastructure adequate to meet theag Transportation Needs for national and equitable distribution including world communities, communities of color that have been disproportionately hit by the covid19 pandemic and districting a global vaccine will require extensive air travel via cargo flights, do we have the workforce and capacity to achieve this logistical feed . One thing that does worry me is the requirement for the vaccine shipped and stored at minus 70 80 centigrade which requires atce least dry ice constantly, they are doing study now, the company is being very good in, in his heart, there is no historical precedent maintaining vaccines on dry ice, this has never happened. We have always shipped at freezer temperatures, not minus 70 to 80 so we do worry about that in almost challenge. Thank you. My time is up. I yield back. The chair now recognizes mr. Mullen for five minutes. Thank you. I do appreciate you holding this hearing although i am concerned by the fact that everybody keeps ringing up to politicizing but in some aspects, that is exactly what this hearing is, we are politicizing it. I had a constituent tell me couple of weeks ago that said you can tell a Natural Disaster or National Disaster is serious when a republicans and democrats are both on the same page. But when we start politicizing it, it becomes less serious and that is exactly what we are doing. Members on this panel are biased toward the president and within our testimony, you hear that and that alone drives down the confidence of the American People. Do they really need it . Is it really that serious . The fact is, if youre a vulnerable one, you do need to get the vaccine and union to get when is available, not worrying about if the president brought it out too fast because we think the pharmaceutical companies are fda what allowed that to happen . Are the ones, they trying to get it to the American People to save lives but the more we question under the disguise of trying to say we are trying to keep the American People safe, the more we could actually cost peoples lives and we need to be very careful about that every one of us have a responsibility to the American People in the public regardless of your witness or a member here, we need to keep that in mind. You yourself could be driving down the confidence of the American People. Doctor mckellen, id like to talk to you real quickly about the pharmaceutical companies in the vaccine, do you think the companies would knowingly produce a vaccine that is unsafe for the public. No, i dont think so. They have affirmed the same thing in writing and they are affirming it byng following the fdas guidance on how to conduct the development, Clinical Trials and making sure they are doing safe manufacturing as well. So President Trumps administration with warp speed, using the pharmaceutical companies are fda or cutting any cornersars and developing the colored vaccine . The warp speed process is happening much faster, i know that makes people faster about courting corners, its important to recognize fda is viral world, even from warp speed so the work that the government is doing in operation warp speed with the companys unconditional manufacturing and for large trials getting them up and running up unprecedented pace is different from the review going on independent life fda. The oversight within this accelerated process to make sure we are not cutting corners on the safety andd effectiveness of the vaccine. Anybody else want to add to that . Will if not, we will go on. Are you confident of vaccine is authorized, it will be safe to the public . The other commissioners grew up in heaven allor say they are confident in the process as well. Weve heard that from doctor tony thought she, collins and other public administrations. Thank you. I dont have anything else, i yield back. You have five minutes. Covid19 vaccine, the experts have been direct and straightforward and out standing and helpful. We cant go off the fact that the administration Public Health response to covid19 has been weak and overly politicized. Has costs a lot of pain. The importance of developing a safe vaccine is paramount. Once a vaccine is approved, we will face the daunting task of determining it across the country the effort to be successful, everyone must Work Together, federal agencies, states, territories and local immunities in our Public Health agency. The last hearing, i asked the vaccine manufacturers about the importance of our state and local Public Health professionals in Vaccine Distribution they all agree our local, trusted Public Health agencies are critical to successful p distribution. Communities across america are very diverse in the covid is one of the many weaknesses in our longestablished Public Health infrastructure but it will be more critical than ever that our state and local Public Health professionals are empowered to implement effective and timely vaccine dissolution. He pointed to this infrastructure, key components of the successful covid19 Vaccine Distribution and uptake stating that we can leverage our nations existing Vaccine Distribution to ensure equitable access to covid19 vaccines. What role will they play as the partners for effective distribution . Do you want to highlight any weaknesses in the infrastructure now to address . Thank you. We dont need a a vaccine, we kw from experience from china, vietnam, thailand, new zealand and taiwan, you can get pretty much zero cases based on the Public Health practice and both would be the cdc guidelines i discussed previously and guidance so we know a vaccine is critical and will help but we could do this without vaccines with the publichealth tools we have today if we wanted to critical to make that happen is that we have strong state and local, infrastructure to do what needs to be done in terms of isolate, contact, and sure Community Engagement around wearing masks, social distancing and handwashing. The same infrastructure will be put to the test as we try to undertake the most complex vaccine National Campaign weve ever done before and others have highlighted why its more difficult than what we have done for example, in 2009 so do they have the people that are necessary to do all this . This is not just the epidemiologist, laboratory people, the i emergency planner, publichealth advisors, a complete publichealth core people we need to make sure they have and associated resources with those people to ensure this vaccine is well planned and has a need to get out within our communities. What is your view . Youve devoted your life work to publichealth and boosting trusted authorities in the infrastructure, what we need to be focused on right now . I would just add to what he already said, we need to do is make sure we make it possible for the systems we know have delivered for decades and decades and what they need to be successful. All of the things people have already talked about around building thosein systems, it starts with building the confidence within those systems, adequately funding those systems, making sure we have the personnel and making sure we have data systems in place that will be so important for continuing to track the distribution. I am afraid because over the past decade, for the publicHealth Agencies theyve left them with her on that we dont have the same kind of infrastructure in place so what can we do . Part of it starts with having the right kind of National Leadership in place, its always been important for vaccine efforts we have a strong cdc, that the other agencies involved in the immunization programs are fully funded, have the support they need so it starts with National Leadership, National Guidelines which is what the state territories and tribal leaders look to to be able to do what they do for the state, local and territorial level. You have to have those systems in place with the national guideline, the infrastructure and make sure those are then partnered with state, local and territorial leaders who are really the ones who can get to the people and make sure these programs are implemented but it takes having their own system. You cant have these fragmented systems, you need the whole system working in tandem. Thank you very much. Recognizes mr. Duncan. Thank you. The hearing to vaccine ensuring a safe and effective vaccine people will trust has taken a lot of different paths today and it has been interesting to hear commentsre from my colleagues in congress but also the panelists. Comments about we dont need a vaccine, we can do all these other things and we are spending billions of dollarsou on velvetf a vaccine and i dont disagree. If necessary, we have ai flu vaccine, we could take a lot of the same steps and probably eliminate a lot of folks testing the flu might we push a flu vaccine every year end it is interesting to hear banter back forth, talking about how youre not trying to politicize it but you are doing exactly that by pointing out the president said this, that, hes a businessman who had to rely on the cdc experts, and epidemiologists to give him the advice. They have been all over theve board so if they are advising the president and hes been all over the board, because of the advice is givenrd by nonpartisan members of the cdc. And other organizations that advise him i want to ask doctor mcclellan, i understand vaccines and related biological products, an independent form of government and pharmaceutical companies evaluate data concerning the safety, effectiveness and appropriate use of vaccines. Last year the American People had confidence this committee will provide unbiased recommendations regarding a covid19 vaccines to the fda mission when we seen so much partisan rhetoric from all fronts, not just my colleagues but the media and other groups, how can we help, that this committee will provide unbiased . I have confidence in the committee because is goes from light own experience. Not a time of this level of Public Health emergency but a series of Public Health emergencies including dealing with the first coronavirus, sars and the agency is used to getting pressure in different views, both political pressures and sometimes having different views and interpretations as well as evidence of evolving over time but what we thought might be the best answer in february wait a minute, stop you right there. Let me just say, you just said is the Novel Coronavirus, we are actually learning things about the virus from the time it came on the scene in january until today, things we learned, we shipped course, right . They are saying the president has lied to the American People they shifted course based on the knowledge we learned about the virus, that not be fair to say . I think to your question, do i trust the Advisory Committee . I trust it will bring all the information together and use the fdas expert oversight and experience to enable fda to make an informed decision that reflects all of this science that is a process we should have a lot of confidence in. So let me talk, the last vaccine hearing in july, how they would create a vaccine safe and effective for the most vulnerable population, we know the most vulnerable are, 60 plus population, especially those with Underlying Health issues and an interview he did, regarding individual and up age group, i cant see how anybody, the Advisory Committee whatever a lot of oxen recommended that Group Without having adequate data. Do you stand on that statementou today . Sure. I am on the Advisory Committee. I can tell you how we operate. Thats what we are. Politics doesnt enter into the adult. Doctor fauci only operates as a scientist . Absolutely. You think the othero advisories operate as scientist . I think doctor collins and redfield has operated as scientists. They advise the president about a Novel Coronavirus about covid19, which we learn more and more about as the buyers has been evident within the population so sure, as the data comes in, remedies and other things will change. But you have to be open minded to that and adjust recommendations based on the and now we know. You will have rose garden meetings or rallies where everybody is inside, not wearing a mask. Ve it was still pushed. There is no evidence that it would work but it was pushed. I dont understand why we are having this meeting, we shouldnt need this meeting because we should trust the fda largely because what happened with the administrations pushing the fda to do things that shouldnt be doing. Thats why i am upset. You have five minutes. Thank you. Can you hear me . Just. I want to return to a topic thats been touched on, im very concerned about declining weve seen when it comes to the covered vaccine field working on we see confidence decline over the last few months, pretty stupid asleep. Only 51 of u. S. Adults now would get ati vaccine if one wee available. Thats down from 72 in may. A Foundation Pool found 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 its safe and effective so that is not a good situation and its very alarming as we are trying to tackle this pandemic. In your testimony, you emphasize trust of the vaccine will be important, if not more than the safety and efficacy. That is a pretty powerful couldent, i wonder if you elaborate on that. When you think of vaccine, you always think of efficacy and safety redressing have to put trust other otherwise it will not be effective. Talk about that a little bit. Thank you. Ill give two specific examples. The first example was with the1n h1n1 outbreak in 2009 when individuals failed to get vaccines when i thought there was supposed to get that day. In the end, i believe only about 27 of americans got the vaccine. The mistrust and what they were being told. The second example is highly efficacious line vaccine taken off the market in three years not because of concerns about efficacy side effects but perceived side effects so essentially within the board of trust in the vaccine was on the market so there are two examples right there with trust being critical to allow us to get Vaccine Coverage as we would like. You are pointing to this trust for the h public and how careful we have to be in the process in order to convey a sense of comfort and safety and efficacy that will allow people to take advantage off this opportunity when its presented in the is whats really at stake in calls forhe real concern. He said in your testimony the administration politicization with signs in areas like math and social distancing as well as the push to approve drugs like hydroxychloroquine or biological such as convalescent, without evidence of safety or efficacy caused some to wonder whether the same standards would be on the Covid Vaccine. Answer this for me, we could go a long way toward restoring trust could we not . If the president , the administration and political people, not the Public Health experts but the political books operate in a space beginning with the president whos leading the executive branch, if they would align themselves with Public Health, experts follow them, it doesnt mean watch over the process, it doesnt mean you dont make sure its being vetted properly but you convey your view of the Public Health experts, scientists, the people of the ones who are going to call the shots and couldnt th that, very quickly, that were the posture the president and administration took, could that begin to restore trust in a meaningful way . Could you speak to that . Absolutely. People look to the president for leadership in other countries have been much better at getting on top of this pandemic and the biggest reason, the most powerful thing, more powerful than vaccines. As im walking down the halls a thele weeks ago at Childrens Hospital, the hospital is loaded with children with covid19. I would choose to mass every time over a vaccine and it is a powerful tool and the president could do too much to promote that and he doesnt. I grew up in maryland, huge fan of your father. Thank you, very much. I yield back, i would say if youre fighting with the Public Health experts, youreth politicizing it and if you align yourself with them, your deep politicizing. Do we have mr. Burges on the phone . Hes next on my list but i dont see him. Going once, going twice. Mr. Peters, a half minutes. All right, sorry about that. [laughter] a lot ofti my questions have ben answered but i think reporting on this hearing, the idea that it not be political and i think to throw an bone to the administration, i like the idea of the week doctor doughty has characterized this warp speed effort. Attraction is developed, hes emphasized over and over, the risk we are taking is a financial risk and i think that is appropriate so once you have bought formulation that you would be able to hurry up and make itt available, it makes al the sense in the world but its important for all of us, you may call this political and if anything, you cant set a date for the vaccine to be safe. Thats something that has to be followed through the process that we have developed over many years in which we are not just lucky to have but to have in our country to develop these vaccines. We have the confidence in our Public Health infrastructure from Research Industry can come up with a vaccine. I think we all v believe that is true. Maybe we would like to see a one dose vaccine but in any event, i dont think it is inappropriate to call out any politician who suggests the timeline should be modified to fit a political schedule. So just say i appreciate the testimony of the witnesses and ill yield back in. I agree with your comments, do we have mr. Clark on the phone . There she is. You are recognized for five minutes. Thank you so much. Ive been listening attentively. I will raise the issue of being a new yorker who was at the upset of the outbreak around things we can do to really drill down on how we continue to protect ourselves. I am concerned about the messaging around Public Health protocols that have been working in tandem with our awaiting of a vaccine. Acwe know it focuses on what muh of the world is anticipating, the approval of a safe and effective vaccine for covid19 and we are all rooting for that but we must keep in mind the bigger picture. Public Health Experts have been warning for months, a vaccine, while critical, will not be a Silver Bullet. I want us to draw back home with the American People when i see there being retreating from the initial protocols have brought new york city down to record lows and we are beginning to see small optics because i believe people are beginning to relax around Public Health protocols. Doctor shaw, we can all agree a vaccine will be a critical tool. Why wont it be like the thing is which . Will vaccine alone be enough to stamp out the virusus or will we still need to rely on other Public Health measures . Thank you for the critical question. Of course, we all wish it would be like a light switch that we can look on life would go back to 2019 and we could move forward. There are several reasons why wont be that way. First of all, even under the most of jamaicas scenarios, i dont affect expect vaccine to 8 be 90 or one 100 effective. If its 70 or 80 effective, theres so little we know about what would happenn after getting a vaccine, your ability to transmit to others, its highly unlikely that 95 of americans will get vaccinated. Sixty 65 flu vaccine. Given all these issues of hesitancy, a lot of people will take it so 70 of americans get the vaccine, which would be wonderful, and 70 efficacy, that doesnt get you population level, everything is done but lets be clear, it would be immensely helpful, allow us much of our lives back but there will still be some highh risk will be managed very carefully, will continue avoiding large indoor gathering without masks but i think a lot of the things we care most about, schools and work, all of that will be possible again and thats why vaccine is so incredibly important but it is not a silver all and even into 2022 and 23, who will still be dealing with this virus, so hopefully much better than we arere today. Thank you. Your testimony, we cannot wait for a vaccine to contain this outbreak. We must use the Public Health for what we have available. How does a vaccine the into the larger strategy for fighting covid19 . Its not a Silver Bullet instantly the pandemic. Youou have to unmute. Thank you. I think he actually and simply stated why a vaccine is sufficient, he needs to sitre on top of the Public Health response. We know this Public Health response and contained disease from expenses and not just multiple countries but what we saw in new york and what we see in the northeast so we know these Public Health measures by scientists to make a difference, we know what the control is, there are four things you need to do, we know this from janua january. The first is integrated, coordinated, local, state and raNational Leadership, evidenced based, consistent messaging, looking at metrics. Number one is leadership. Number two is drive down Community Transmission trace, isolate and quarantine people. Number three, increase Community Engagement. Mass, handwashing, social distancing and symbol for, which we are doing a very good job at his death among people who unfortunately still get inducted and its markedly improved options of therapeutic markets but those are the four things we need to do and we still have not fully infamous of those in the yet which is why we see 750 deaths a day and why we cant wait for the vaccine to drop these deaths down to zero or as close to zero as we can get. Thank you very much. After expanding what i did in new york city, it pains me to see the recommendation what is going through, they have not learned from our last. I hope this discussion today in collaboration with the vaccine will provide a guide, a roadmap that instills quickly with the answer to keeping americans safe. Thank you so much. I believe the subcommittee has asked the questions and ile am pleased we are joined by several members of the full committee were not members and im going to start with congressman carter, you are recognized for five minutes. Thank you very much for participate. O let me begin by saying practicing pharmacy for 40 years, its important. The recommended a product to a patient, it was important for me to bee confident that it would work for the patient. Having said that, a lot of times today, we still talk about the politicizing but if you will, og this whole vaccine in this whole process i just want to say as a healthcare professional is a pharmacist, i find it irresponsible that members of congress would be doing this. This is something we should all be together on. I have seen the process work. Over 30 years, ive seen products that went all the way to the fourth stage and were not allowed to go any further. Ive seen that happen and that has built a confidence in me and the process in knowing that the process works so thats all i say about politicizing this whole ordeal. I want to talk about something that is very important, the distribution of this and making sure we have the process in place. The critical aspect of allowing pharmacists to be able to administer this vaccine, 95 of americans live within 5 miles of a pharmacy. Pharmacists are the most accessible Healthcare Professionals in america. In order to make sure when we get this vaccine safe and effectivee and when it is out there, in order to make sure it gets out, would you agree pharmacists need to be able to administer this covid19 vaccine . Yes, i agree. We got experience in the pandemic, playing a Critical Role in access to testing and helping people respond more quickly, get greater access there and helping with flu vaccines and other issues that play into the pandemic as we talk about already today and they are in important part of that trust, people still trust the doctors and pharmacists is gone down for fda, unfortunately and that is another check on making sure will have an effective vaccine that can be brought to the public. Pharmacists have a Critical Role to play. I appreciate that. One of my favorite stories is the fact that i went from being a pharmacist, the second is too just profession in america, to the second least. It is important for pharmacists to be able to administer that. Weve got a situation where a lot of the state has authorized, we need a blanket policy, if you will so we can have all pharmacists, whether its independent retail chain retail to administerr this to get out quickly. You were a former cms administrator and i wanted to ask you where are the issues that deal with pharmacists get reimbursed and bill medicare for these types of things. This has led to a lot of problems and we are trying to get a temporary pharmacist provider status so promises would be able to get reimbursed for administering these vaccines. Obviously weve got to have insurance, coverage and everything we should have iner order to administer the vaccines. Thats something weve been working with in trying to get that done. Do you agree congress should grant temporary authorization for pharmacists to be able to administer this vaccine . If that is what it comes to, cms has authority to expand scope of practice and coverage in a Public Health emergency. When i was there, we did that and circumstances like hurricane katrina, there are precedents for handling this administrative was this goes with today, while there seems to be brought agreement that fdas process of approvalbe to make a vaccine available are in good shape, we all have work to do together on the distribution and act vaccines will on and look to see what activity of the state, local levels focusing on that since we do have a good program in place for the safety of the listing itself. Right. Madam chair, this is not a partisan issue with pharmacists being able to granted provider status to distribute and administer these vaccines. I solicit your help as well as my colleagues on the other side of the aisle, everyone on this committee be able to help us, to grant temporary provider status promises to administer the vaccine. I think you got it, millions of americans get their fluno shs at pharmacies so we will Work Together with you on that. You have five minutes. Thank you. Thank you for allowing my colleagues from georgia to wait on. Its one thing people have been talking about all day, both members and witnesses with covid19 vaccines is safe andes effective, making sure it is available , it will be critical when we know itt is safe. Given the magnitude of the challenge, i appreciate the Committee Roll on helping shed light on the challenges we face. You noted in your testimony while we sometimes except a certain level of potential harm in any experiment of treatment for those who are severely il ill in my frozen . I believe we have foster can you hear me . We can hear you now. I believe i have a just of herth questions. Whether to authorize a covid19 vaccine, would [inaudible] do you know what . He thinks he gets the gist of your questions so we will go ahead and have him answer. I think she was directing that to me so the question is really important, this is important for the American People to understand, we do use a different bar for using emergency preservation for therapies because these are for sick people who otherwise might die and youe have a lower threshold for what you call effectiveness and when you get vaccines, give it to Healthy People. We know how to protect Healthy People without a vaccine, having people wear masks and social distance, all the things we know about so you have to have a relatively high bar for authorizing a vaccine. This is a basic principle of medicine, first do no harm. When you intervene with Healthy People, you have to have clear evidence that you will do more good than harm to that person and thats what one of the reasons why you said and actually, the idea aroundai vaccines knowledge and are built around that and its critical to all of us that theal processes e followed in the covid19 Vaccine Development. I am not antim vaccine, il make that clear, i did have you are frozen again. I will yield back. Okay, thank you. Pr you can submit questions for the panelists in writing so we can have you do that. The chair now recognizes mr. Bill as he is still with us. , i think he is sitting down you need to unmute, where did he go . Okay. We have lost him. Im going to recognize mr. Ohalloran for five minutes. Thank you. Appreciate that. Thanks for the great conversations and information they have put forward this morning. For the past six months, this committee has held multiple hearings between Public Health experts and officials as well as when this is from Companies Involved in the development of the vaccine while discussing Public Health response to the coronavirus pandemic. The cares act as we have seen, the government is making significant investments in the private sector to manufacture a vaccine to protect americans from the coronavirus. In early reports, developing a vaccine, an effective vaccine milestone progress will serve as a weapon for the Public Health crisis. However, americans are confused and scared a full related to weeks ago showed only 51 of adamericans would definitely or probably get the covid19 vaccine if it were available. These numbers represent a 21 drop from the numbers released in may it could be a massive concern. I also want to address the issue of what it means for the development of future vaccines and medicines as we go down a path of injecting politics into this process. This is about scientists and researchers and profits as it has been for many decades. We need much transparency for vaccine manufacturers, Public Health agencies like cdc, fda, nih so the public knows the bigger scientifics discoveries going into the development of this product. Unfortunately, we are seeing the current process for agencies being released daily. Clear and straightforward information from our leaders is necessary to ensure americans m vaccinated when the communications needed from the pharmaceutical companies go hand in hand, there role in business depends on public trust in their vaccines and medications work. The American People transparency from pharmaceutical companies to explain with the bigger trials they dont mean, possible side effects and eventually when a vaccine is approved, the individuals may, legitimately compromised in any way. The first vaccine will not be the last vaccine and hopefullyth not the only vaccine. Id like to ask you, cautioning his politician adjusting vaccine will be available, when you talk about how political intrusions into Vaccine Development process for harming Americans Trust in our Public Health officials and Public Health agencies and how this will os be of undivided importance with americans be able to be vaccinated with a safe and effective vaccine approved. Thank you. 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 we all vaccine yesterday that we want a vaccine that is safe in effect is and we have to wait that process. When i hear ceos saying we dont have access to the data or political leaders who are plus picking specific dates and say we will have a vaccine by a specific d date. I am hoping they are not meddling in the process but it makes the American People deeply concerned because they dont know all of the safeguards and we all worry the safeguards will be ignored. For politicians to basically be quiet and stop talking about data andp move forward and run t by the fda and other scientists based on scientific principles of the vaccine is ready forin authorization and eventually tuproval. And not the day before then unfortunately enough so we have to work on. Thank you and high heel. Said mr. Bilirakis you get the last word and i will recognize you for five minutes. Thank you madam chair. We had technical issues and im sorry about that before but thank you for giving me the time to understand your capacity with the National Academies but a diverse population and largescale covid19 Clinical Trials i wanted to ask whether yourur devastation 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 and 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 t have had really Close Relationships with them throughout this pandemic and we will continuereh to work with or department of Public Health to make sure thatur these efforts actually serve all people so we dont have specific details out but just to say that this is something we here in chicago i feel is incredibly important and we have always put efficacy at center. We will stand by her Public Health department and make sure that we can be part of making sure the vaccine when its available is something that is available in an equitable fashion. We are talking about in this hearing putting the focus on equity and Health Inequities have been part of this pandemic that ive highlighted the longstanding Health Disparities that exist in this country among people of color. So this continues to be a big focus for us as an organization and clearly something thats highlighted in our report. Thank you. Our next question is for dr. Khan. Can we reach out how can we reach out, tell us how to reach out to communities and groups that are disproportionately affected by covid19 by the high rates of Vaccine Hesitancy and who are the most effective messengers to these, communitis which i think is so vitally important. Dr. Khan if you could respond i would appreciate it. Thank you congressman bilirakis. I would say you need to reach out to them with your current concerns about how this disease affects people of color disproportionately, their access to care, their access to testing so that needs to happen now based on those issues to develop the trial for the vaccine to be available in n that needs to be done by local and state Health Departments working with the local Community Organization making sure you are engaging faithbased organizations and not work. Thats what good Community Engagement needs to done as part of that work you can protect that Community Today with the tools that are available to us so please make sure that you make yourself available when somebody calls and please wear a mask, wash your hands and social distance. Working with the community to decrease transmission will markedly increase thees trust oe the vaccine comes in to help our communities get vaccinated. Are you familiar with the vaccine efficacy and Education Programs and if so do these programs increase Public Confidence . I think most people are hesitant are skeptical and they should be skeptical. You should be skeptical of anything and if you asked me if i would get a covid19 vaccine right now im so optical as everyone is. So i think when thats true i think you use reason and logic and passion and compassion to explain the data and explain the data and let people know its not a riskfree choice. You have to explain heres what we know. We know the vaccine is safe and 20,000 people but that doesnt mean its safe than 20 Million People but there safety features in place to find those events when they occur. Lets say a 75 effective when but we dont know how long its effective but we will know that overer time so theres a questin is not whether youd know everything, we dont know everything but those things we dont k know how where you find out and the most reasonable people theres a group in their much Smaller Group who i would call antivaccine activists. These are conspiracy theorists that believe that pharmaceutical Companies Control everything. I just dont think you can reason with them. If someone comes to conclusion without using logic corp. Reason you are going to talk them out of it using logical reason and i think thats true here. Id say 85 of the group who are concerned about vaccines are reasonably concerned and can be talked down as long as you provide data and clear compelling and compassionate way. Thank you very much prevailed back. Thank you and i want to thank all of the witnesses. I think i can speak for everybody on both sides of the aisle here that in agreeing with what dr. John said that the integrity of the Research Process that we have had so far, we have the pharmaceutical Companies Working at break neck speed or operation warp speed and we are hoping we will get a vaccine as quickly as possible but i think you and the other panelists said we cannot thwart the timeline and all of us have to be ready to accept the timeline with facts but we cant be stating dates. Related to the nation includes not just meddling in the Research Process but also announcing that deadlines are timelines before they are really appropriate. I think its imperative that we follow the process. Compared up at the public have confidence and thats what this hearing was all about today. Frequently people ask me why do you do oversight here and the reason we do oversight hearings is to shine a light because sunlight is the best disinfectant and we think the moree we have experts like you coming in and talking about the process and what we need to do the more likelihood is that we will have a process that will notro the negligent and will produce not one bit more safe and effective vaccines for that want to remind members that they have 10 Business Days to submit additional questions for the record to be answered by the witnesses to appear before the subcommittee and representative angle and i want to ask the witnesses respond quickly to any such questions. We have some documents on the record and we have mr. Walden request the second wave trajectory poured on vaccines and therapeutics from the minority staff dated july 1 of 2020. The Clinical Trial protocols from fort covid19 vaccine manufactures visor as to zeneca and the letter signed by nine drugte companies on the safety f covid19 vaccines dated september 8, 2020 or the fda guidance in the vaccines dated june 30, 2020 a usa today opinion from senior fda career september 10, 20 team could we have a Washington Post opinion for seven former fda commissioners on the Trump Administration undermining the credibility of the fda dated september 29, 2020 which i offered and then we have the oxfam report of the world covid19 vaccine supply dated september 17, 2020. Without objection these articles and information will be evidenced in the record and with that thanks again to everyone. Without the committee is adjourned