Transcripts For CSPAN2 House Hearing On Ensuring Safe COVID-19 Vaccine 20240712

Dramatically. I would echo the callers point the Administration Needs to listen to Public Health experts. We know what we are talking about. Let me ask you about a tweet from the president. Lets take you to a Live Committee hearing on how to develop a safe and effective Coronavirus Vaccine. A safe and effective vaccine could hasten the end to this disaster us pandemic but the herd immunity that would end covid19 once and for all would allow all of us to get vaccinated. We need public trust in the entire vaccine project. Around the globe nearly 200 vaccine candidates are being developed and 20 have entered human Clinical Trials. In the United States five have entered human trials with large Clinical Trials that begin later this month. With a historic all hands on deck effort underway the timeline to develop a vaccine may be compressed from several years from 12 to 18 months. Moving with this amazing speed must not allow for cutting any corners. Today we will hear how the tried and trusted vaccine review process. This remains the best in the world and we will hopefully through this process develop this vaccine in record time. This nations scientific warhorse spend latenight in their labs, we in Congress Must do our part to protect them from political rattling meddling. Some standards of scientific analysis and ethics. We are not here to place that kind of vaccine horse race, from individual vaccines to the experts. We must entrust science to the scientists, not the politicians. I want to protect the Vaccine Development and ensure the safety and efficacy of a covid19 vaccine. The most important hurdle for a vaccine to be safe and effective is to successfully undergo phase 3 Clinical Trials. According to conditions, phase 3 Clinical Trials must include at least 30,000 people. This is a requirement endorsed by nih director Francis Collins and top Infectious Disease Authority Doctor fauci. Fda must receive and consider advice for the vaccine and related biological Advisory Committee. In the area of vaccines, they have a sterling reputation and played a central role in assessing new vaccines. Review of the covid19 vaccine by a body of experts from academia and industry will add transparency, public accountability and scientific insights to the approval process. These are critical values for a vaccine that will undergo intense public scrutiny and require participation and trust by the public. Up to this point fda has failed these two guardrails with fellow oversight chairs Carolyn Maloney and jim cliburn, i were to commissioner stephen hahn asking for his commitment to a 30,000 trial participant requirement for human trials and engagement with burbac. A month later weve received no response. Fda commissioner hahn testified to congress about the high standards of the fda. Commissions with 30,000 trial Participation Rate as well as engagement with burbac would be concrete ways to defend that. We must remain vigilant. Must not distort the decision on whether or not to approve a vaccine. We must expedite developing a vaccine but we cannot cut corners in the process. With that, i would like to recognize the full Committee Chair Carolyn Maloney for her opening remarks. Thank you to all your colleagues and i want to thank each of our witnesses about the importance of promoting transparency to assure the Coronavirus Vaccine is safe and effective. We are fortunate to have such a distinguished panel on the subcommittee and im grateful that youve taken time out of your schedule to share your insights with us. I would like to recognize doctor Jason Schwartz of the yale school of Public Health. I have the privilege of hosting him last may, im delighted to see you again, doctor schwartz, thank you for joining us and i want to really come in the leadership of the chairman in convening todays briefing to ensure the safe and effective Coronavirus Vaccine is developed and made available following the protocol of the fda to ensure safety to our people, im grateful to your leadership many grateful to be a partner with you on this critical issue and i yield back. Thank you very much and sorry for the delay. It is a way to make sure each of us get an muted so that you can hear when we talk and i would like to turn it over to Ranking Member cloud for your opening remarks. If you would like so we can unmute. Can you hear me . Thank you for holding this hearing. This is an important topic, dealing with a pandemic that ravaged our nation and it is important to come together and address the healthcare issues very intentionally. I would note right off the top we have the ability to hold hearings as opposed to briefings which would follow rules and i request the majority considers future hearing, over the last few our country has been affected by this, congress afforded 3 billion in research and development and diagnostic for covid19 through the cares act. The Trump Administration has worked tirelessly so we can uncover the challenges the virus poses and ensure that we found the best therapeutics to develop a vaccine in record time. To this end donald trump initiated operation warp speed which empowered our government to work with private sector to manufacture 300 million doses of a vaccine to have those by january of 2021. Donald trump because of his immense effort, to have an effective vaccine widely available by the end of early 2021. This is an incredible feat in context, the h1 in one vaccine relied on 70 years of flu Vaccine Research, took eight years to develop an ebola vaccine. The American Public should rest assured the administration and interested partners are not sacrificing safety or efficacy while developing this vaccine. We will not be cutting corners in development of this vaccine, it enabled this to happen simultaneously. It just allows them to be done simultaneously. This does increase cost of production, Drug Companies and the federal government partner together to cover the cost but we can get a vaccine to market faster. Last week the federal government enough two contracts, most have agreed the doses manufactured will be owned by the federal government meaning if the vaccine is proven effective the Us Government would make the doses available to americans at no cost. Other Companies Like moderna and astrazeneca put low prices on any vaccine approved. The goal is between the low prices and existing programs no one would go without a vaccine. Finally insuring equitable access the cdc has been working to develop a ranking system for vaccine distribution. Those serving on the front lines like our medical professionals or underlying convictions will likely get the first dose ensure you are most vulnerable are protected. I look forward to hearing from the panelists today, and have access once it is developed. Thank you so much. I really appreciate the remarks. Everyone participating and asking tough questions and that produces a real robust conversation. We have five witnesses. I will quickly say their names, doctor guillen, doctor goodman, doctor karen, doctor schwartz, we are now going to start with doctor guillen. You are recognized for five minutes. There is a timer on your screen and i appreciate you and all of us speaking for five minutes. You are recognized. Can you hear me . Banks. Good morning, members of the subcommittee. An important discussion today and the work youve done to ensure the response to the pandemic is guided by the best science and best scientists. Im doctor bruce guillen advisor with the safe Vaccine Institute in washington. The inventor of the vaccine, to make vaccines more accessible, enable innovation across the globe. The cdc, nih and Deputy Assistant secretary for health, at hhs, we are familiar with the deeply disturbing statistic of the pandemic, the us continues, the virus has taken a disproportionate number of american lives and to be on the Health Impacts no sector of society has been spared at the economic and social reckoning will be grim and difficult to predict. Various efforts to flatten the curve, social distancing the handwashing and face covers are all important to help to control the virus, it is clear that only population wide immunity will dampen the ongoing spread. Only population wide will we stop the spread of covid19. There is been an unprecedented effort to develop and deploy vaccines for the Us Population and around the globe. This is extraordinary and marked by collaboration, innovation and speed. The focus of todays briefing is how we ensure that all of this is safe and effective. In addition to good science which is a good turning point, three crucial elements in the success of this effort. Developing a successful human vaccine, steps can be taken in parallel and without sacrificing an assessment of safety and efficacy. The fda is to be commended for developing a vaccine, directed to industry, so all other considerations go into the process but a lot of effort to push these to the American People at warp speed may be well intended but misguided desires to shorten this, shortcuts could shortchange the process and we know cutting corners comes in a price. The consequences of such a misstep, what wasnt expected would have serious implications, to trust the American People, the process we have come here to discuss was a recent poll found the adult population, and these results are a window into the confidence the American Public has about this process. And the Advisory Committee act, the best ever to provide independent advice to government in these meetings are open to the public and transparency in the trump equation i recommends, any type of accrual by the fda, with the related biological products. In that committee, the robust can additions they have. Stories will appear, vaccine approvals made behind closed doors because they didnt want the public to see what or who may have influenced those decisions. The best answer that would be some shock. And they would be safe, helping our trust. Trust in the research and development process, vaccine licensors, trust in a vaccine policy process, trust in the providers who recommend administer vaccines to patients and once vaccines broaden the population there was a system in place that continues to assess those efforts. In the end americans want to understand what the process isnt being filed and not shortcircuited. And to way their decision this, they choose to be value vaccinated when the vaccine comes available was at no doubt when a vaccine is available a Vaccination Campaign in the us will be visible to all americans and given the frustrations and delays a critical element of the Pandemic Response lets not forget that pattern. Its not too late but a plan in place to communicate to all who want and need to know. People lets build it and sail it, nobody wants in conclusion the guardrails ashore safe and effective vaccines beyond compliance with rules and regulations, compliance will not assure a Successful Campaign that will end this pandemic. There must be transparency in the Vaccine Development process. There can be no shortcuts in the bill for rebuilding the government Vaccine Developers in the public, need to get started on these matters, thank you. Thank you. Next i would like to recognize doctor goodman for five minutes. Can you hear me now . Good morning Committee Members. Im a disease physician and professor formerly fdas chief scientist and helps with many Public Health responses and i directed the center for biologics evaluation and research, monitors vaccines for us news and i do appreciate the opportunity to be here today. It can save lives for the potential to provide widespread immunity and stop the outbreak through the worlds population. For this reason there unprecedented references to Vaccine Development we have heard about. The manufacturing is complex, success is never assured and we can speak the process, we must not cut corners. We must assure any covid19 vaccines maintain trust. And the agency must uphold and be transparent for standards and scientific decisionmaking. In a recent article that outlined four safeguards in development. Strong evidence of effectiveness. This is best accomplished in large control Clinical Trials involving thousands of individuals and vaccinated and control groups. To ensure things worked and those who need the most trials must include diverse populations as well as elderly and conditions. Fda recently published guidance that it should be 50 effective, a reasonable starting point. The effectiveness of covid19 vaccines is not different. Against other corona viruses and immunity may wayne quickly. We need strong evidence of safety. Unlike treatment given to the sick vaccines are given to the healthy and must be extremely safe. This is a novel disease for which we have no vaccine precedent and many are based on novel technologies not yet utilized to ensure that they have preapproval safety databases that increase 7000 individuals. In addition, safety and general population factors studies should move ahead given the risk they face in their roles with other essential workforces. We need to be thoughtful about Vaccine Access prior to approval. There may be circumstances of unapproved vaccine, appropriate for severe output. It is not submitted, fda provides access to expanded Access Program or emergency use operation. The us is designed to enable responses in Public Health emergencies but have lower evidence in fdas normal effective standards. It may be effective and many benefits outweigh risks. It is the same as approval. Vaccine used turns out to be any effective or raise safety concerns and users are unclear that it was unapproved, a crisis did occur and therefore a vaccine is used, informed consent to be part of the process and be targeted to those at highest risk of infection and complication. The highest safeguard is robust Monitoring System as things are rolled out. It was not detected for preapproval. Also the vaccines administered occur coincidentally after vaccination and it is critical to ashore. The 2009 h1 n one vaccines the system captures government and private sector data first vaccine doses. To communicate that the vaccines were safe. We need a system in place now, not later, with full transparency how safety will be monitored and communicate. While working to get covid19 death quickly, these safeguards are sure will be safe, effective and trusted. Thank you, i look forward to the discussion. Thank you, next, doctor karen, have i pronounced your name properly . Yes you have. You are recognized for five minutes. Good morning. My name is ruth karen, pediatrician chain trained in Infectious Diseases and professor Bloomberg School of Public Health where i lead the center for Immunization Research and the vaccine initiative. My work is focused on respiratory virus vaccines and vaccine policy, with respect to covid19 vaccines, likely be a coinvestigator for two other vaccine trial scheduled to begin this summer. I had the honor and privilege of serving on two federal Advisory Committees, i served as chair of burbac at a cip, the cdc Advisory Committee. More than 3 million americans have been infected with the virus and more than 137,000 have died. This virus profoundly affected us all. For racial and ethnic minorities, the development of covid19 vaccines, vaccines will be the best tool to this pandemic. This is not a competition. Most vaccines increase the chances that we will have effective vaccine for sufficient quantity to affect people worldwide. The populations included in vaccine trial, the necessary safety and efficacy data to inform decisions about vaccine authorization licensure. We need to plan for the careful, open and transparent evaluation of all trial data. To protect all members of our society. This will be critical if the fda reviews vaccine trial data without making decisions about emergency authorizations, the review of trial data and recommendations for licensure, two important purposes, the public and fda have the opportunity to hear about questions and concerns, the leading independent vaccine scientists, the fda and other members have the opportunity to hear and respond to public concerns in an open public forum. This following winter safety and efficacy data will be emerging from covid19 trial. As doctor goodman just described decisions need to be made about issuing euas for one or vaccines with data promising but incomplete. Questions about risk and benefits for populations are high risk groups must be discussed by burbac using all available data with clear acknowledgment of what is known and unknown. Decisions about licensures, covid19 vaccines must be made through burbac engagement and review. We need to make certain vaccine safety and efficacy information reviewed by burbacs representative of our society. Trials must include bonds in diverse racial, ethnic, geographic and age groups. In particular we need to ensure native american populations are far more likely to become infected with the virus and likely to die from covid19 i not only offer opportunities to participate in these vaccine trials but also choose to participate in them. For this to happen we must acknowledge the high level of trust that exists in many communities, we work urgently to engage communities, build trust and ensure that vaccines will be free and readily available. We must also have a clear plan to meet the needs of pregnant women. A recent cdc report indicates pregnant women, particularly black and latino women make increased risk for hospitalization and icu admission. If we dont have one vaccine offered to pregnant women, we cant protect all of our essential workers because pregnant women are doctors, nurses and emts, police, teachers and nursing home aids, Grocery Store workers and factory workers. We need to plan for systematic Data Collection for those who become pregnant during upcoming vaccine trials, prior vaccine manufacturers to reform studies as needed, engage experts in separate pediatrics and Research Ethics for designing studies to include pregnant women. Building confidence in covid19 vaccines is essential, the best vaccine in the world wont work if it isnt used. We must begin by developing trust in the Clinical Trial process, providing open, transparent, independent expert review and analysis of Clinical Trial data for decisions about vaccine licensure for emergency use authorization. Thank you and i look forward to your questions. Thank you, doctor karen. Next, doctor schwartz, you are now recognized for five minutes. Thank you, members of the subcommittee. Im assistant professor the permit of Health Policy and management at yale school of Public Health. Is the focus of my research and policy and policymaking, particularly evident in the forms and developed a vaccine regulation, financing, promotion and delivery by Public Health agencies. My primary message for todays briefing is as follows, interfacing a Public Health process unlike any anyone alive today has experienced, the speed and urgency around vaccine developed a similarly unprecedented but the closer our Government Health agencies adhere to establish timetested processes for evaluating safety and effectiveness of covid19 vaccines in developing evidencebased approaches for their deployment, more confidence the public and having the integrity and quality of those decisions, the more likely it will be that covid19 Vaccination Program approach the High Expectations being placed upon them. This is no time for improvisation. In the United States we are fortunate to have an extreme we robust and wellfunctioning system for continuously out that evaluating the vaccine before and after their approval in producing widely respected evidencebased guidelines for the use. This designs principally in the fda center for biological evaluation, research and the centers for Disease Control and Prevention National center for organization and respiratory diseases. These scientists have arrival expertise for the work regarding covid19 vaccines that lie ahead and this can be supported by the longstanding external expert Advisory Committees that for decades supported the government regulatory and policymaking work around vaccines. Referring specifically to the vaccines and related biological products. The advisory can do, the fda and Advisory Committee on immunization factors that the cdc. For 50 years Advisory Committee 7 regular and influential contributors to the fda supporting regulatory responsibilities related to the vaccines, pharmaceuticals and other products. And access to preeminent scientists and physicians in the federal government for new evidence and recommendations, Advisory Committees expand the expertise available to support perceived legitimacy. It often does fda Advisory Committee help to enhance the transparency of decisionmaking in accordance with provisions of the federal Advisory Committee act, largely occur in public. Members of the public to takehome opportunities for key relevant evidence regarding safety and effectiveness of product to comment directly to the committee at fda, this kind of transparency can be extremely helpful and lead to concerns about the decisions for potential allegations regarding interference in scientific assessment. With respect to vaccines, an active contributor to fda work, inspiration in 1981 as my colleagues on the panel, as covid19 vaccines move ahead of develop and each effort should balance obvious urgency of the work with the assistance there be no compromises for safety and effectiveness affected of any vaccine in order to authorize or improve use. It is encouraging that statement fda leadership have thus far appeared sensitive to this challenge and responsibility, and externally difficult scientific and policy questions ahead involving evaluation and use of covid19 vaccines that would benefit from more eyes or perspective or expertise or institutional dollars or transparency, not less. Longstanding practices and norms for effectiveness to vaccines in general and populations, including participation for expert advisory as they have done for decades to help agencies and public content to the vaccine eagerly anticipated. Public confidence is fragile and has undergone threat in recent years with no preapproval evidence for due process no matter how rigorous would illuminate the possibility of unfavorable evidence emerging after a vaccine is approved and widely administered taken by the fda to counterpart of the mother had can reduce that possibility. The emergence of a serious safety concern related to covid19 vaccine or the perception by the public for political pressure to apply in a rush to approve it would be damaging not only to covid19 vaccination efforts, but also in recommended vaccines, and the Healthcare System cannot bear the burden of simultaneously battling covid19 alongside outbreaks of influenza and other Vaccine Development diseases. Thank you to members of the subcommittee and participating in todays briefing. Thank you, doctor schwartz. You are recognized for five minutes. Good morning, Committee Members, thanks for the opportunity. I am a Health Economist and professor of medicine where i direct the center for demography. I have 20 Years Experience working on my academic work, i work with federal agencies, dns and issues related to access to care, quality of care and worked for the last several years with the fda for the center for evaluation and research on biological products for the safety. I want to address two topics related to Vaccine Development in the context of covid19. First the safety on the front end and policy mechanism, should they prove safe. The other experts said the development proceeded, absolutely remarkable. Identified 23 in the evaluation for 137. The vaccine candidates include variety of technologies with the same goal of producing the same antibody response that neutralizes the virus for covid19 infection. Absolutely extraordinary scientific effort in response to the challenge. The Rapid Development brings quarries for the safety, idle worries that vaccines are biological agents that need to be tested thoroughly in a wide population. Even discredited challenges, like the case of the mmr vaccine levee leave many people without vaccinations. I want on this point to say two things to address you in the American Public about the process the fda follows. First in my experience working with a part of fda that evaluated the safety of the vaccine, worked for several years, i found the fda scientists on biological drug and safety that i ever encountered. We have followed the data diligently in the decisionmaking. They look at the data and care deeply about safety. The fda in the last on june 30th issued a state of guidelines for industry regarding what you expect to see from the trials regarding the vaccine. Among the sets of guidelines involve rigorous standards of safety and effectiveness that affect the standard for the trial of phase 3, now there are people with statistical standards. It requires 3000 more people and more than that, many more than that for this trial. They cant mandate industry quality standards but the fda will evaluate that. In addition to the standards and guidelines, with elderly folks, people with chronic disease, almost in role the effectiveness of those populations during the trial. It is an approved statement for market surveillance on the guidelines and also traditional factors of the fda that monitor the safety of vaccines after there was in use. When you have a vaccine used by millions of people you would expect what you find outside in the fda works actively to assure they are inactive. The last thing i want to address his operation warp speed. The administrations plan to develop a vaccine. It has too many parts, to provide Financial Support for studies of the most promising vaccine that played an Important Role in acceleration of the Development Effort for the vaccine and to make Financial Statements for vaccine doses even before the regulatory process. What i want to emphasize, the study that was conducted and valued by the regulatory process having corners on safety evaluations, the second part for the regulatory process in a sense is a gamble. What if we invest a lot of money, that is the downside. Tens of millions of doses are available, not quite so hard. It makes an enormous amount of sense. In a sense operation warp speed is independent of the fda process. What it does is avoids a fight over who gets the vaccines first if the vaccine shows up to work. The process makes it so we understand the vaccine is safe and effective and if not that will turn out to be a way to invest but like any gamble, works out, much smaller than potential gains. Let me finish with the last bit, only my own 0. 02, we should get the vaccine first. An enormous amount of evidence to suggest elderly people with multiple conditions are at high risk of complications from covid19 infections. Operation warp speed will make it for fight over who gets the vaccine should the vaccine prove safe and effective will be less of a political a factor of a wide range of issues. I believe all americans should celebrate together if and when it is a safe and effective vaccine developed. Operation lightspeed will work to make that rather than many other aspects. I hope the vaccine comes soon and i appreciate it. Thank you, doctor. Thank you to all the witnesses. Now we will begin the and a. As a reminder each member will have five minutes to do their questioning and we will try to observe that so all members can ask questions in a timely manner. Once recognized please wait for confirmation you have been muted before asking your question not several times, people Start Talking before anyone can hear them and looks like a silent movie. We dont need that. We will try to wait before starting the question. I would like to recognize myself for question. You talked about burbac, sounds like a strange committee that exists in the government but as someone mentioned it was created when Ronald Reagan first took office. It has been around almost 40 years. Please introduce us to it, what kinds of people sit on this committee and what is its reputation . Its reputation is providing unbiased, careful assessment of data and communicating that to the fda and the public. Typically members of it have a wide range of expertise ranging from basic science, pediatrics, internal medicine, biostatistics and these people may come from Public Health backgrounds, consumer representative and industry representative. Sounds like one of the biggest positive aspects is it has public deliberations but widescale understanding of what is going on. Would you agree with that . I completely agree. The public can understand a 2way process and can also make their concerns heard because it could be the fda has not yet heard what is concerning . Very good. Would you agree burbac should be engaged in the process currently underway for determining a safe and effective covid19 vaccine . I would absolutely agree, yes. Im extremely concerned. I want to turn to another topic that the fda choose to prematurely grant an emergency use authorization to a vaccine for covid19 just as it did for hydroxy chloroquine which they later revoked. We heard about operation warp speed but im concerned about the doses handed out at warp speed and in the context of the covid19 vaccine. Under current law does the commissioner have the authority to issue anyway before completion of the stage iii Clinical Trial . Yes. Regulations around emergency use authorization are flexible and require Public Health emergency at the secretarial level and fda assessment of the science that says likely benefits are largely got it. Do you think in emergency use authorization should be issued to bar the completion of a Clinical Trial . Im concerned for the reasons doctor goodman mentioned in his Opening Statement that emergency use authorization would not be understood to be different from the full approval of details of the fda and moving forward, without the evidence we want to have on effectiveness and taking a serious gamble so i would be concerned about that. You would be concerned that it would be potentially dangerous. We would be moving with less of it than we would like to have with vaccines, the importance of clear confidence in their safety is paramount and moving forward with what we would logistically have an effect for full approval. You have a strong preference the vaccine go through the full approval process including burbac for any kind of eua or approval were granted. I would like to see it work to be considered, could absolutely and should be part of those conversations as well no matter which path they consider in the months ahead. Based on what we saw with hydroxy chloroquine do you have any concerns here . There are many questions, phase 3 trial you heard is the robust opportunity to take a look at a large segment of the population. That is what is needed to make a responsible decision. Doctor karen, one last question. There have been reports that convalescent plasma with antibodies concerning immunity before their coronavirus and doctor Anthony Fauci called it an effective concept. They explore convalescent plasma even before the vaccine arrives . This harkens back to my comment that it not only applies to the multitude of vaccines but the multitude of countermeasures, whether plasma or antibodies, both of these approaches are promising and we should assure those. My time has expired, Ranking Member cloud is still with us. I can hear you, i cant see you yet. I recognize you for five minutes of questioning. Appreciate it. Appreciate your time and research in science, help us out with this. Has operation warp speed made any steps in the approval process . Not to my knowledge. My understanding is operation warm speed enabled a speedier process by simultaneously running through the process of Clinical Trials, is that your understanding . That is my understanding. Allowed the process of understanding in the trial process is parallel. I am sure you could take 45 minutes on this but could you compare and contrast the normal process versus what the administrations approach is . In a normal process that involves federal investment, the normal process involves safety trials like we are saying that are currently in japan. The normal process would involve guidance to manufacture what we have seen. It is normally, it is a higher standard. It signaled very clearly, high standards for the vaccine. It goes beyond the normal no process to wait and see and imagine a business, manufacturing this product, operation warp speed, manufacturing those products that go to work. Files and needles. If it doesnt work, if it does work, to deploy the vaccine the lengthy process is for companies to minimize the administration prioritizes in saving lives for strategic financial risks. It is absolutely the goal. The public is essentially drug manufacturer through the studies in the work carefully with the registered process, with a statement at that. If it is. It is money that does that. Dont make the gamble but produce the vaccine that works to get the first, many lives are lost. You are a Health Economist. There has been a tendency sometimes in dealing with the seriousness of covid19 to look only at covid19 and not in the context of dealing with covid19 but other impacts of lockdowns and shutdowns. Can you speak to the other Health Implications we are seeing . Ive seen an increase in the number of suicides and Mental Health effects, delays in basic essential treatment including other vaccines. Weve seen delays in cancer treatment, basic essential treatments have been avoided i suspect over the long haul we will find a big increase of other Health Problems as a result of the lockdown. Time for one more question. I know youre a real scientist, not a political scientist but theres been a lot of discussion about the politicization of getting a vaccine sooner rather than later, assuredly there would be a political benefit to saving lives sooner than later. Do you think theres potentially incentive for some to delay the process . I would hope not. I am definitely i would hope people come together and say visit the data and see about the effective vaccine. I agree. We look at the data and evaluate it. Thank you, i agree. Hopefully all of us agree the data should drive the process. Chairman . Ranking member cloud, chairwoman maloney, 5 minutes of questions. The hearing today, i want to thank the panelists for the dedication to science and hard work and being on the panel today. Operation warp speed, a safe vaccine to be approved, 300 million doses will be available by january of 2021. We are also eager for a vaccine to be developed i am troubled by reports that there may be some political pressure on the fda to cut corners. I am encouraged that our panelists do not believe that. What harm would come from cutting corners in the rush to bring a corona vaccine to market . We have heard a lot about the processes of Vaccine Development. The lengthy process is to reduce the financial risk. Anything that can be done to collapse that time without minimizing it, make sure all the data from these Clinical Trials is thoroughly investigated in terms of the immune response and particularly the assessment of safety. In the rush we might miss something we look at in retrospect and cant afford that. How can we maintain an expedited timetable when completed all the steps to assure a safe and effective vaccine . One of the comments was the process we put in place we 10 years ago, the independent group looking at the data, the safety data. An unfortunate name of Vaccine Safety Risk Assessment Working Group but its value is the data is coming in every month. It had a public process that everyone could see what they are looking at. Things would be really important, the public can see what we are seeing and see if there are any signals. That is a good recommendation. It is imperative that safety comes first in Vaccine Development, it must be employed in a way that ensures distribution, accessibility in all countries. To ensure affordability and prevent profiteering at the expense of the American People. Unfortunately hhs has not so we continue to press for this. Dr. Schwartz, like you turn to you and its good to see the again. Ensure that everyone in the United States has free access to the Coronavirus Vaccines . Thank you, chairwoman maloney. Yes, i yes, i think its right n after we overcome the scientific hurdles in Vaccine Research and development it will be difficult new set of challenges regarding production, distribution of the vaccine to achieve the benefits we hope. That will require every bit as much a coordination government leadership to think about the issues around deployment and we have particularly dissent for Disease Control and prevention of parallel group of experts with years of expertise to think about those allocation and distribution issues and we need to make sure theyre both empowered and the government has the resources to purchase and deliver the vaccine. Theres a tremendous amount of work that lies ahead if and when were lucky enough to have a vaccine that shows the kind of promise we are all hoping for. You were saying the federal government is already planning and investing its resources out to ensure a vaccine is a point successfully . Im not so sure about the level of investment but i do know expert advisor at the centers for Disease Control are already thinking about these questions route privatization in terms of how we might think about where the first doses, when we know we wont have nearly enough to meet demand but where those first doses can go. That work is already moved forward. It will be more than thinking and planning. Will be resources needed to scale at the Vaccination Program if and when we have vaccine. A lot of work needed and a lot of success required. Finally once the vaccine is to put will need to continue practicing social distancing and taking options such as masks, is that correct . Absolute. Vaccine will be an invaluable supplement to the tools and responsive where using a book intended to use. It will not end the store in terms of how we respond to covid19 but a very valuable tool as we try to maximize the benefits of vaccines. The story will continue with the vaccine to the spectrum of public response that window can be affected if they are thoroughly and safety followed by the public. In the closing i think the german, all the panelists once again for your leadership, and i thank you, chairman for holding this critically important briefing, and i yield back. Thank you chairwoman maloney. Next were going to recognize congressman grossman. Are you with us . I thought i saw now am i on . I carried you. I can see you yet. Can you turn on your video . Okay. Just a minute. Ill see if this will get it on here. Let me see. There, just a minute. May have to go without my face. Let me see. Does that work . Not yet. Should we there are in. There you are. We got you. We see you. Uncle to start off by questioning something you said. You are recognized for five minutes. Go ahead. You started off by saying we have to go with the experts. My concern is frequent expert barry. Right now in the United States we spend, who might spend the most for healthcare for any country world, so the more than a lot of other westernized nations. I think we take more medication than any other country in the world, and despite that our Life Expectancy is not necessarily higher than other countries. So in other words, i think the experts are getting a lot in this country wrong. My doctor talked about pills and procedures that we seem to have almost a a blind faith in this country towards medications and more procedures. We have to remember that before we just say that more, more, more is always better. I also think that throughout this coronavirus crisis, the socalled experts in the Public Health field, to me have got a lot of things wrong, okay, police in this state they told people to stay inside. I read expert saying outside, both for the fresher and for the sunshine. I think they were overusing ventilators. I think they way overestimated the number of deaths, least in my area. There were cleaning out the hospitals. You couldnt get what were considered to be elected procedures or that sort of thing, any of which were lifesaving. And and i think there are a lotf experts now say people died because we were not doing certain procedures in hospitals waiting for this delusion of patients that never should have and, frankly, in my district nurses were being laid off deluge of patients hospitals were emptied out. I want you to remember throughout this that experts disagreed and i think the Public Health establishment has screwed up a lot in this right now. In my district the people that i talk to, the more thoughtful people, will be very jaded about anything they come up with. But im going to ask in general, ill come back to this idea that we ended up hospitals, couldnt do a lot of things. We have some members of the panel. Could you tell us how the Public Health establishment screwed up there . Do you believe they did screw up . Whenever so methinks they were not doing in hospital that could be lifesaving in anticipation of this big deluge of patients . And why should i, what should i tell the people back in my district when theyre going to question the experts forever because they had been given so much bad advice from them in the past . I guess the question is to me. I think in the early days of the epidemic, theres quite a bit of uncertainty. For instance, the death rate from the virus, the early models had the virus has way more infectious than it turned out to be [inaudible] as a result, the lockdowns, i believe have i think the lockdowns are important tool in some places where hospitals overrun. As you note many, many parts of the country have seen have been emptied out in anticipation of the virus and it didnt come until later. I think the experts made enormous mistakes early on, and i think a lot of the skepticism in that sense is warranted. I dont necessarily we should stop [inaudible] continue to look for good data. Debate among experts, not silencing experts that disagree. [inaudible] should be acknowledged experts disagree. Okay, just one other comment and then i will let you guys go. Right now somebody corruption by judy who is very sometimes very provaccine, sometimes jaded about vaccines. We have five people i think on the panel today and nobody is particularly jaded to the degree to which she is. I wonder if people feel somebody like her should be on a panel today or be in the room as we rush vaccines to market . Could somebody comment on her . Do you think would be good at somebody on the panel like this who maybe thinks where a little bit over vaccine in america and isnt going so gung ho vaccine everybody . We can ask you again. I dont know her in particular, but i think that putting the best data out there and having transparency so [inaudible] decisions been based on i think public debate about. A lot of intelligence and, we read a lot, are sometimes a little jaded on the vaccine thing. Everybody on the panel is go, go, go. If i could just comment briefly. I think you heard from weve had our concerns about because there are legitimate concern and who want be sure everything is done so as vaccines, when vaccines are available, theres been a process in place that ensures they are safe and effective. Even on this panel we have been quite clear about our concerns that everything done to ensure those things. The other thing i would. 2 is i will stop. I have to jump in. Were kind of going over here. The waitress can finish the answer. Just one last comment. What we are is exported. We never heard of this virus six or seven months ago and now unbelievable amount of science degree so many questions but the amount of sites that is come forward has been remarkable. But watching sites in realtime can be confusing because every day you learn something else. To take a step forward, a step back, step aside which we need to continue to look at that science and to look at it from a distance as we can agri looking at everyday makes it confusing, and one study seems to say one thing and once is another, and we will need to assemble the best data for two understanding of where we are. Okay, very good. Thank is so much for that line of questioning. Let me turn it now to congresswoman pressley. You have five minutes. Thank you, mr. Chairman for direct directed our collective focus to this critical issue. I want to thank our esteemed panel of experts for joining us to ensure our conversation is rooted in science come in Public Interest and equity and the sidebar would like to go on record and say and dr. Fauci i trust. Today im reminded of doctors, doctors solemn promise, hippocratic oath, do no harm. If we seem to develop a safe and effective vaccine our approach of Public Health must prioritize that simple principle. Do no harm. Unfortunately, the current occupant of the white house has been his entire life cutting corners to get results at the expense of others. We cannot allow that pattern and practice to compromise the ethics that guide our medical community. This been dimmick estimates that more than any other time in our nations history the need for deliberate process that values equity and inclusion. According to data released by the cdc, black and latin excitizens are hospitalized at more than four times the rate of White America due to coronavirus. These are the same committees underrepresented in Clinical Trials as Health Research of many effects hope to put an end to the harm caused by covid19 it is absolutely critical that work is informed by those who are hardest hit. Operation warp speed needs to make time for Health Equity before it is too late. That kind hopes to successfully merge from the Current Health pandemic, every step of the process must be fair, inclusive and equitable. Dr. Gellin, why is important to include volunteers from Diverse Communities . Thank you. Weve heard a lot about the size of the Clinical Trials which is really important. Because the size of those trials as you heard from others allows you to look at population segments in the you will be recommending a vaccine for people, in this one would expect the recommendations will be for everyone. Well have a discussion about the order. We want to make sure those vaccines work and are safe in these different populations. And leisure sufficient numbers of each of the subsets, you may not have full confidence and how to perform when theyre used more broadly. Very good. Dr. Gellin, how are communities of color, could you elucidate ask him how are few meters of color typically engage in the Vaccine Development process . While, and others will elaborate and maybe dr. Karron whos doing this Clinical Trials all the time will want to comment but the vaccine develop and process obviously involves people. People are recruited as volunteers into studies and i could be a challenge. When volunteers do or do not want to enroll. This effort there needs this special effort to ensure that when you look at the broad swath of the population that the Clinical Trials include representatives from those populations so that we will have the information on those segments, whether im sorry. I do want to call on dr. Karron. Certainly equity has to be centered in everything but theres also real fearbased on history if you look at Henrietta Lacks and the tuskegee experiment. Dr. Karron, what are researchers doing now to ensure we can get the data we need from starkly underrepresented groups . So i can speak to some of the work in particular that warp speed is doing and the worst beat investigators are doing. They are engaging now with Community Leaders with members of faith organizations, with potential volunteers themselves to understand what their concerns are and how they can help allay those concerns. And its also very important, there are a few things have identified. One, very obvious and very important thing is that some of the study personnel also need to be part of this group. They need to be approached as he said by people who look like them. Another key point and it is one that i hope i highlighted in my remarks is that many of these individuals have said will i be able to get a vaccine at the end . Will my family . If i participate in these trials, the vaccine be freely available . Ultimate access is tied to the engagement. Okay. Thank you, dr. King. I wanted to elevate the fact dr. Karron. Women are also often underrepresented in these trials. I want to turn to what happens after the Clinical Trials. Even if the vaccine complete phase three trials there could be insufficient data how it affects at risk populations. Black americans, the elderly, those with existing health conditions. Dr. Goodman, could the fda still approve of backing the did have evidence of safety and efficacy for diverse publications . One of the ramifications of doing so . What are the ramifications of doing so . The intent is to prevent that inherent population in these trials but yes, fda would look at the data and lets it one group is underrepresented in it. That could be reflected come for example, in the product labeling or in recommendations for how it is used. Fda also can require additional studies after the initial approval. So its very common, for example, certain groups not just minorities but the elderly are often underrepresented in some trials. Fda can require studies and data be collected after and submitted. I do think it is very important to get back to one of my comments that we need a robust Monitoring System that cuts across all the candidate vaccines as they are rolled out to track data on the safety and effectiveness. That will tell us about anticipated problems that might occur in specific populations. Very good. In closing i will say when a safe and effective vaccine is made i think it should be widely accessible and free to all. Cdc director redfield confirmed to be in whatever earlier hearings that testing a treatment would be free for all. This must also apply to the vaccine and we must now act to ensure an equitable distribution especially for the hardest hit community. Thank you. I yield. Thank you, congresswoman pressley. Now i would like to recognize congresswoman miller. You have five minutes. Thank you, chairman krishnamoorthi, Ranking Member cloud, and all of you witnesses for being here today. The covid19 pandemic has highlighted many issues that exist with our Healthcare System. However, the pandemic has also demonstrated what can be accomplished when we develop public and private partnerships committed to finding treatment and vaccines to not only tackle covid19, but other diseases as well. Im encouraged with the administrations commitment to streamlining the process of a vaccine and treatment while definitely ensuring that safety is above all a priority. Operation warp speed has been a testament to scientific innovation. Dr. Bhattacharya, i concern regarding the safety of vaccines has been an issue in the United States as well as other countries. As a Misinformation Campaign continues to grow, what should we do to help combat the deception . I think theres Nothing Better than providing good data input information. Maybe youre talking about the i think the early publication incredibly damaging. I think any future i think the vaccine that comes out of this process i can politically with my colleagues, that making that the transparent data and available so everyone can see what the safety concerns if there are any is absolutely critical for the trust of the American People. It seems we need to take some kind of additional steps to increase the awareness so that we can help grow the confidence in the integrity of the decisions that are being made right now to the potential of these vaccines. Can you speak to the challenges of developing a pharmaceutical treatment or vaccine for a coronavirus illness . Its absolutely enormous. In the vaccine we would have to decide what types of the virus are most you have to test whether antibodies whether survive the virus. All this happened before you even touch a human with that. Once you start putting it in him just to make sure all populations safe response all this happens in phase one trial. Phase two and three you start a broader population. A diverse population such important this vexing be very widely deployed. To see if theres any special concerns in in the population t of sample sizes that are enormous to make sure you are seeing if they exist, to measure the effectiveness and you have to long periods of time whether the vaccine is safe and effective. Under all of those, normal social circumstances extorted thing about the effort come scientific effort thats happening is thats happening in just a months time. Things that would normally take years. It is incumbent upon as as a scientist to convey to the American Public the findings, very, very clearly and loudly in terms of people can understand. If there is no safety signal, if it is effective we should say that absolutely loudly and not there is a safety signal and if its not as effective as we hope to say that also. I have very folk of his and the scientists that they will say what they find. [inaudible] the data are used by a presenter on the trunk, the trials are under enormous amount of scrutiny both by the fda and by the public. [inaudible] that include a lot of this concerns other Committee Members have raised, including the representation of the first populations, sample size am looking to safety signals. I believe and again maybe im being naive but i dont think so. I think were going to see a lot of information, and learn a lt about whether these vaccines work and speedy i hate to interrupt you but i want to make the point back when i was a very small child, i remember standing in line at my Elementary School with my mother to get the sugar cube for polio. I have friends who have polio, and i excited about what the possibilities can be and i also feel that there are Many Companies that have agreed to donate millions of doses to the federal government for distribution. And i just want to see what is it to ensure that those doses are distributed for all americans across the country. And i think that operation warp speed is a step in that direction so that we dont have to fight over who gets the vaccine. Its potential if those doses if the vaccine works and distributed widely, medicare cover sick, have you in medicare it for free. [inaudible] that every person with Health Insurance would get it. So i think there are mechanisms in place allow those vaccines to thank you your yield back. Thank you, congresswoman military network like to recognize ms. Tlaib. You have five minutes. Thank you. Yes, i know, im multitasking. Im so sorry. Thank you so much everyone for being on this call. I mean, i think one of the things i wanted to focus on and thank the chair before this, is to really talk about their effectiveness, right, and safety. As we all know is that it seems like its a good step towards some transparency and goal setting but i think dr. Karron, want to start with you with some of the basics. Will a successful vaccine, what will he successful vaccine to and how will that phase three trial make sure the vaccine does what it needs to do . Thank you very much for that question. I think in the guidance there are several possible outcomes, Outcome Measures that could be assessed. I think the most important thing for a vaccine to do is to prevent severe illness and death. And i think the fda guidance does speak to that and say that at minimum much be a secondary outcome and could be considered as the primary outcome. Other outcomes that can be looked at but in my personal view are less important are preventing any covid disease. Because i honestly think that even a vaccine that could prevent severe disease and death but still allows mild disease to occur would not be a failure. We would count that as a success. And what does the fda guidelines mean when this is a vaccine must be proven to be 50 more effective . 50 , and must have 50 efficacy. So what that would mean is that somebody who is vaccinated would have 80 less chance of having a particular outcome, whatever outcome and if i can could i just make two comments about that . In some ways many of our vaccines are 90 effective or 80 effective, and i and i think maybe the American Public might think 50 is a low number. But but a couple of things to sy about that. One is that frequently what we see with vaccines is that they are more effective against worst disease, so that a vaccine that is 50 effective against a mild disease might be even more effective against severe disease. And the other thing just to say is if we had a vaccine, if we had happened and death in this country that weve had from covid, that would still be a major accomplishment. The subcommittee will a letter to fda asked for a commitment to 30,000 participants. We havent received a response yet i believe, right . I dont think we received a response yet. One permanent part of a a trial design is the number of participants but the fda has been so desperate so what are the risks of having too many, or too few people in the Clinical Trial . And one of the things dr. Collins and dr. Fauci endorsed phase three trial of at least 30,000 people. You agree we need to hit the 30,000 mark . Im sorry, that question is to me or now. No. Me. Those are great question. I think they are outlined well in the guidance. You heard from dr. Collins as well. Reasons we talked about should 30,000 be the question . Sure to be 30,000 . I . I think thats a pretty good number. Seven because that will allow us to look at some of these groups in the population what we often see one of the things dr. Karron mention, some of the Advisory Committees is when the data comes through, while, you wish you knew about some group and we need to go look at that. Setting that kind of marker makes to ensure you have evaluation each of the groups who receive this vaccine. Just all have a look at the time the thick dr. Karron, i saw the work you do on a vaccine safety pride to women. How important it to include pregnant women in these safety studies . Its critically important for some of the reasons i mentioned. Pregnant women, the data are still being gathered as to whether pregnant women have more disease than their nonpregnant counterparts that are data from the cdc that suggest black and latino women may suffer more than other subpopulations of pregnant women. But at the very least they dont have milder disease basically deserve an opportunity to be vaccinated, just like other segments of the population for its really critical. Thank you both for your answers, and i yield the rest of my time, chairman. Thank you very much. Thank you so much. Can you hear me . Great. Thank you so much, congressman tlaib. Now we go to congressman connolly. Are you with us still . Can you see. Was i cannot we can see part of you. Here i am. Okay figure recognized for five minutes, my friend. Thank you, mr. Chairman. Thank you all for being here. I want to talk about to think. Efficacy and risk. Dr. Goodman, how long does it take historically to develop an effective vaccine . Well, typically as others have said, several your process but what were seeing here dr. Goodman, i have five minutes to let me interrupt you. What is the fastest vaccine ever developed . 2009 pandemic vaccine, but were based on influenza manufacturing vaccine design. That was several months. Several, okay, but for months . Yeah. For example, how long has aids been around . Well, hiv, now about 20 years. Actually goes back to run 1980, right . Right. So thats four years. Thats what i said. Okay. Have we got a vaccine that is efficacious, that prevents the transmission of aids . No. Hiv has been a really hard target because the bodies immune response to the virus is clearly ineffective. So the spanish influenza, maybe thats more of a parallel, that was 100 years ago, 19171918. Do we 18. Do have vaccine today that prevents somebody from getting the flu . We have influenza vaccines. As you know they change every are based on what strains are circulating, and we also develop vaccines against pandemic threats. You know, maybe an analogy to this is more like Something Like ebola where in the course of excellent development, a vaccine was available in a few years. But the point is most flu vaccines help with the severity of the flu. They dont necessarily prevent you from getting the flu. Fair enough . They do both actually. They are among our and that they typically reduce risk of an actual infection, depending on the population in the year. It could be 2060 but they are more effective like you said at reducing complications. Right. What im try to get at is were talking about efficacy as if it is a cure. But efficacy isnt always a cure. It is sometimes lessening the severity of the symptoms or preventing the worst from happening, or at least showing up your immune system so you are better equipped to try to fight off infections. Fair enough . Yeah, absolutely. As one of my colleagues just said, if we could reduce mortality or hospitalizations, that would be wonderful. I understand but in this conversation i think weve lost sight of the lipid of what efficacy really means. It doesnt it isnt necessarily a cure. In the history of cures to a vaccine, is very limited. Dr. Gellin, risk. Im old enough to remember what can go wrong when you rush a drug to market that was a simple drug, antinausea for pregnant women to make them accountable. And lead to terrible deformities in babysat were born. How do we weigh risk here when hundreds of thousands are dying come millions are getting infected you want to try to end that. What risk is acceptable and what risk isnt and how to insulate ourselves politically from the pressure we are seeing from this president and this administration to kind of cut corners scientifically already . What confidence do we have every taken into account risks . If 20 get accident and develop the scene to the high risk that would be unacceptable. If 1 of them nonetheless get covid19, that might be acceptable. Could you talk about that . Then i yield back. Your questions all point to the same thing. [inaudible] they. 2 the process of review. They point to the independent science of the fda to look at all the data and decision of deliberations. Its always a balance of benefits and risk. Nothing is perfectly safe and nothing is perfectly affected. Its that balance where to look at here. And thats mr. Chairman, i know i just a few seconds. Thank you, doctor could dr. Schwartz be allowed to enter it as well . I saw him shaking his head vigorously and i like to hear from him and then i yield back. I agree entirely. Its difficult question, i subthreshold, questions the how much evidence is needed and this is why we need to defer the kinds of structures and expert mechanisms to sort through these any vaccine prevents in the best of circumstances all the more so so this is why we have these systems. Thank you so much, congressman connolly. Now we recognize, i recognize katie porter, congresswoman katie porter for five minutes. Thank you so much. Dr. Gellin, im i am a mom with three kids and want to make the best possible decisions about i cant or their health and for the own and for our community. And thats why every single year we all get our flu shot. We wash our hands. We wear masks if we are doing the right thing because i believe that science works. I believe that vaccines are safe and effective. Now, imagine we are living in a world six months from now with the fda has approved a covid19 vaccine for use. But i am a concerned. And ive been hearing a lot that the president pressured the fda to approve this do covid19 vaccine. Doctor joachim do you think i might be nervous about getting this vaccine from the kids if i thought the process was rushed or different than the other vaccines that i routinely and know that are safer kids . Dr. Gellin. For the same reasons, and that the information that comes from the studies is going up to inform that. It also raise up the ship were to get your information and who are your trusted sources . I think another layer here is that while this data is very important and very expert committees will be good, its critical that people on the front lines, the doctors and nurses who are going to be delivering these vaccines, they will be asking, ask questions by you and patience also feel confident in the process. They have to know that it was undertaken it away, the way that was going to bring about the best results and understand what that was, and they need to be the translators of that information and theres probably no other trusted source of a people you entrust your health and her Childrens Health too. If theyre not part of the solution, they will be part of the public are another piece of this is to make sure the data thats going to be reviewed is translated and provided to the front lines of medicine so they can answer questions like yours. No, i really appreciate that because i think most people are not going to be reading medical journals, not going to be going to the fda website. We will be googling and they will be on facebook and it will be asking their friends and youre right to point doctors and nurses are like my childrens pediatrician has been their pediatrician since then been born but im also would i will not be getting the shot from the kids pediatrician or i will be getting it from a mass Public Health setting so i think it support the fbi put out that information in an acceptable way, including to providers that we can reach out to. What happens if people hear these stories about i actually am not i dont know. I havent got the usual information that i get. What happens if we are 4050 of the population gets the vaccine . Because they dont trust [inaudible] unfortunately, the story you mentioned already out there. Even before vaccines it is to with Clinical Trials. I think the solution or response is coming to and i can against this information to the degree that we cant which is not easy to do. That is separate from your question a lot of mathematical models about what it would take to achieve herd immunity to stop the virus. But i think if we see the vaccine has worked and see that it is damping the disease process, i think that will increase the comfort of those who might be skeptical to ask a it is actually working and then they rethink a decision been made previously, which is why that information history critical he out there and we need to make sure the people on the front lines are able to respond to peoples questions like yours. Thats really helpful because i think weve seen in the past months what happens when the public doesnt understand or is given any kind of mixed signal about the Science Behind Public Health and virus prevention, wearing something as simple as a cloth mask has become an aggressive debate. And social distancing become more and more controversial. The science is a bear. Things like Wearing Masks and vaccines do work but because we havent had a clear decisive message from the federal government about the scientific validity of things like social distancing and Wearing Masks, they become divisive. So we cannot risk the same thing happening with a vaccine because it so imperative that every person who can get this vaccine once it is developed does so. Is there anything more at the fda should be doing with regard to create that kind of Public Confidence for vaccine adoption . I think we talked about the public process is an important part of it. There also needs to be an effort to communicate things in a way people can understand them. Often the language of the experts is not so approachable so we need to translate that some people can understand what it means. We had a discussion a few minutes ago what vaccine means. All of his on the panel can give you all the math behind it but that doesnt mean the people who hear it understand it. Thanks so much and i yield back. Thank you, congresswoman. Now i recognize john sarbanes, you have five minutes. Thanks very much, mr. Chairman. Can you hear me. Was yes. I want to thank the panel. This has been a very, very enlightening hearing. I appreciate so much the testimony about how we have to balance speed with safety as we pursue these vaccines here i wonder and i by indiebound so must respond to this, if you could compare this Covid Vaccine pursuit with what Many Americans are familiar with, which is sort of the flu vaccine, maybe compared in terms of the way the Research Happens around the flu vaccine, the way that gets administered, the extent of uptake of the flu vaccine in the population, what is the confidence level around the flu vaccine, howd you compare that to what you were seeing in surveys about a potential Coronavirus Vaccine. What are some of the practical dimensions of how we would be distributing our Covid Vaccine at the same time we would be distributing the seasonal flu vaccine. Since thats the frame a lot of americans have in terms of a vaccine that comes at them on a regular basis i wondered if you could droste and comparisons at analogies of their on those various [inaudible] i can address that. The flu vaccine, the big uncertainty has to do with blood strain of [inaudible] have to make best guesses about that but the knowledge to produce the antibody response which are identified what strain you think will be predominant is wellestablished. By contrast, in this case we dont know how effective the antibody response is from the vaccine. In that sense more uncertainty about this vaccine the seasonal flu effort. The same time the amount, the number of people in the trials is extraordinary that the we will have a lot of information about whether to some extent even more than [inaudible] i think its both more and less uncertain because we dont know about we know what the virus is unlike the flu we dont know the strain. Less uncertain [inaudible] i think youve asked a critically important question. Because as you said, in peoples minds these are similar. We read a lot about the pandemic. Pandemic. Weve heard about the parallels and we expect this is somewhat be like influenza. Thats an important conversation because i think you just heard some of those. This figure weve all seen about flattening the curve. That comes from work 15 years ago from influenza. You flatten of the curve to keep you out of the way of the Healthcare System until a vaccine arrives. It has been decades of experience making influenza vaccines can we knew we could do it. We knew we could get there. It was just matching the strength of the pandemic. This is different. We are flattening the curve to keep people out of the Healthcare System while were working on a vaccine that we dont know will work. Thats the key difference. You asked a number of questions we could distribution, the simultaneous use of vaccine and a Covid Vaccine. These are all very important questions. I think we all need to be working on so there is an confusion about these. Thank you for asking. I have 45 seconds to get someone could just speak to this question of confidence in the public relative to the flu vaccine, what is the percentage uptake that we get on a seasonal basis of that vaccine . How does it relate to peoples perception of whether its risky or not risky or risk involved compared to what you hearing out there to the Covid Vaccine . Quickly, half the population gets the flu vaccine the confidence is filed about safety. The conference is how well it performs. Theres a lot of work thats been done to try to improve the performance of the vaccine and thats people dont get is probably because of that now because any concerns you have about the safety thank you, mr. Chairman. I yield back. Thank you so much. I really appreciate everybody who participated in todays hearing. Especially the panelists. Thank you for a grueling session of question and answers. And also want to just conclude by saying that we all want to vaccine as soon as possible and i think that goes without saying, and what to expedite the creation of a safe and effective vaccine. But the only way to do that come at a think theres relative unanimity on this particular point as as a from everyone ons panel that we should not cut corners at the fda. Perhaps there might be some efforts to expedite what we do in the manufacturing of vaccines. Perhaps we think about the economics and the prioritization of delivery of the vaccine. Simultaneously, with the creation of such a vaccine, but we must not cut corners and do anything that will hurt or harm the conclusion that whatever the fda ended up approving a safe and effective. And so i hope that come out at this hearing we proceed based on those two conclusions to make sure that the fda does its job. Commissioner hahn answers our letter, that he assures us that he will continue to maintain the independence of the fda, that we will have 30,000 participants in any stage three human trial, and that it be engage fully in the deliberations surrounding a covid19 vaccine. With that i like to thank you all for participating and this session is adjourned. Thank you. Our live coverage continues at 1 30 p. M. Eastern when joe biden talks about his clean energy plan. We will take you live to wilmington, delaware, for that announcement today. At 3 30 p. M. Eastern susan rice former Obama Administration National Security adviser and u. S. Ambassador to the u. N. Will talk with Washington Post columnist jonathan capehart. They will discuss u. S. China relations and her potential to be running mate for joe biden. Then at 4 00 eastern dr. Fauci director of the National Institute of allergy and Infectious Diseases will discuss covid19. He speak at event hosted by georgetown university. You could watch all of these events online at cspan. Org or listen live with the free cspan radio app. Carl smith joins us the assumed serves as Vice President of the tax foundation, discussion on tax policy and