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

Within minority communities toward the medical industry. Thank you to all of our witnesses and, of course, my colleagues for joining us. Todays reading is about the extraordinary effort underway to develop a vaccine to prevent covid19, safe and effective vaccine could hasten the end to this disastrous pandemic. But the herd immunity that would in covid19 once and for all requires all of us, all of us to get vaccinated. For that we need public trust in this entire vaccine project. Around the globe nearly 200 vaccine candidates are being developed and over 20 have entered human Clinical Trials. In the United States, five entered human Clinical Trials with large Clinical Trials that begins later this month. With a historic all hands on deck effort underway around the globe, the timeline to develop a vaccine may be compressed from several years down to just 12 or 18 months. However, moving with this amazing speedos not and must not allow for getting any corners. Today we will how we must place trust in the food and drug administrations tried and tested vaccine review process. We will learn how this process remains the best in the world, and we will hopefully through this process produce a covid19 vaccine in record time. While this nation scientific workforce spans late nights in the lab to produce the vaccine, we in Congress Must do our part to protect their work from political meddling. So that they can uphold their professions utmost standards and scientific analysis and ethics. We are not here today to place the kind of vaccine horserace. Relieve the careful assessment of individual vaccines to the experts. We must entrust science to the scientists, not the politicians. I want to highlight to guard rails that protect the integrity of Vaccine Development and will ensure the safety and efficacy of a covid19 vaccine. First, the most important hurdle for a vaccine to be deemed safe and effective is to successfully undergo phase three human Clinical Trials. According to tradition as well as the science, phase three human Clinical Trials must include at least 30,000 people. This is a requirement endorsed by nih director francis collins, and our top Infectious Disease authority, dr. Anthony fauci. Second, fda must receive and consider advice from what is called the vaccine and related dialogical Advisory Committee, also known as vrbpac. In the area of vaccine, vrbpac has a sterling reputation and for decades it has played a central role in sbas process for assessing new vaccines. Review of a covid19 vaccine by this body of vaccine experts from academia and industry will add transparency, public accountability, and scientific insights into the approval process. These are critical values for a vaccine that will undergo intense public scrutiny and required full participation and trust by the public. However, up to this point fda has failed to commit to these guardrails with fellow oversight chairs Carolyn Maloney and jim clyburn, i wrote to fda commissioner hahn asking for his commitment to a 30,000 trial participant requirement for stage three human trials, as well as engagement vrbpac. A month later we precede no response. Two weeks ago fda commissioner hahn testified to congress that he was named in his bed and a High Standard of the fda. Commitments to a 30,000 trial Participation Rate as well as engagement with vrbpac would be concrete ways to guarantee that independent and rigor. We must remain vigilant to the [inaudible] political tactics or media campaigns. It does not follow Consumer Sentiment or approval ratings. The impending elections, the stock market and yearning for return to normalcy must not distort the decision on whether or not to approve a a vaccine. We must expedite development of vaccine, but we cannot cut corners in the process. With that i would now like to recognize the full committee chair, Carolyn Maloney, for her opening remarks. And thank thank you, chairwoman baloney, for joining us as well. Thank you to all of my colleagues, and i especially want to thank each of our witnesses are joining us this morning to hear from experts about the importance of promoting transparency to ensure that the Coronavirus Vaccine is pretty safe and effective. Where fortunate to have such a distinguished panel of Public Health experts for the subcommittee to integrate for your taken time out of your schedule to share your insights with us. I would like to take a moment to recognize dr. Jason schwartz of the yale school of Public Health. The privilege of hosting last may for a vaccine roundtable at Hunter College in new york city. Im delighted to see again, dr. Schwartz. Thank you for joining us. Finally, i want you really, really command the leadership of chairman krishnamoorthi inconvenient todays briefing to ensure that a safe and effective Coronavirus Vaccine is developed and made available to the American People following the protocols of the fda to ensure safety for our people. I am so grateful for your leadership and ungrateful to be a partner with you on this very critical issue, and i yield bac back. Thank you. Thank you very much, chairwoman baloney. Sorry for the delay, folks. Its just a way to make sure each of us gets unmuted so you can hear us when we talk. Now i would like to turn over to Ranking Member cloud for your opening remarks, sir. If you would like to if someone could unmute mr. Cloud. Hello, hello. Can you hear me . Yes. Good. Thank you, chairman krishnamoorthi for holding this ring. This is certainly an important topic as were dealing with a pandemic that has ravaged our nation and indeed the world. Its important we come together and address these healthcare issues very intentionally. I would note just bite off the top that we have the ability now to hold hearings as opposed to briefings. Hearings which would follow rules and i would just request that as majority considers future hearings that we would conduct them in a format that would protect minority rights. Over the last few months our country has been affected by this, and congress has provided 3 billion for research and development, vaccines, therapeutics and diagnostics for covid19 through the cares act. The Trump Administration has worked tirelessly so our country cant overcome the unprecedented challenge of this virus poses and she would find the best therapies to treat covid19 and can develop a vaccine in record time. To this and President Trump initiative operation warp speed which empowered our government to work with the private sector to manufacture 300 million doses of approved vaccine with the goal of having those by january 2021. To this end President Trump initiated excuse me because of this immense effort government and pharmaceutical companies, the u. S. Is on track to have an effective vaccine widely available by the end or early, early 2021. This of course is an incredible feat in contrast or in context, the h1n1 vaccine was developed in six months but he relied on nearly 70 years of flu vaccine research. It took eight years to develop an ebola vaccine. The American Public should rest assured that the administration and Industry Partners are not sacrificing safety or efficacy while developing this vaccine. We will not be cutting corners in the development of this vaccine. Instead, operation warp speed enables steps in the vaccine process to happen simultaneously. It doesnt skip steps. It just allows them to be done simultaneously. This does increase the cost of production. Drug companies and the federal government have partnered together to cover the costs so we can get the vaccine to market faster. Just last week the federal government announced two new contracts and one with most of these countries have agreed the doses manufactured under these projects will be owned by the federal government. Meaning that if this vaccine a proven effective, u. S. Government would make the doses available to americans at no cost. Other Companies Like moderna and astrazeneca have pledged to set low prices on any vaccine approved. The goal is that between the low prices and existing programs that no one would go without a vaccine who wants one. Finally, ensuring equitable access to the vaccine once developed is key. The cdc has been working since able to develop a ranking system for vaccine distribution. Those serving on the front lines like our medical professionals, those with underlying conditions and those over 65 will likely get the first doses ensuring our most vulnerable are protected. I look for to hearing from the pedals today on how we can assure the public trusts vaccine and has access to it once it is developed. Thank you, chairman. I yield back. Hey, thank you so much, Ranking Member cloud. Its great to have you at this hearing and i really appreciate your remarks. I think were much better off when edwin is participating and asking the tough questions, and that produces a real robust conversation, so thank you. Let me now turn to our briefers. We have five witnesses. And is going to quickly say their names and then going to turn it to dr. Gellin but we have triple, dr. Goodman, dr. Karron, dr. Schwartz. We are now going to start dr. Gellin. You are now recognized for five minutes. Theres a timer on your screen, and i appreciate you all, and all of us, sticking to our five minutes. So with that, dr. , dr. Gellin,u are now recognized. Thank you. Can you hear me pgh yes i can hear you. Thank you. Ill look for the timer, thanks. So good morning chairman krishnamoorthi and members of the subcommittee. Thanks that this Book Discussion today and for the work youve already done to ensure the response to the covid19 pandemic is guided by the best science and the best scientists. Icarly served as president of global immunization at the Sabin Vaccine Institute in washington. Founded in honor of doctor albert sabin, the inventor of the oral polio execute our mission is to make vaccines were accessible, enable innovation and expand unionization across the globe. My entire career stems largely in the government business and faxing focus at cbc, nhf or 15 years as Deputy Assistant secretary help address the National Vaccine Program Office at hhs. As you already were ultimately with the starley and deeply disturbing statistics of this pandemic. The u. S. Continues to experience record numbers of infections and the virus has taken a of american life. Andy on the obvious Health Impacts no sector of society has been spared and the full economic and social reckoning will be grim though still difficult to predict. While the various efforts to flatten the curve of social distance come handwashing and face coverings are all important helped to control this virus, its clear that only population wide immunity will dampen the ongoing spread and end the pandemic. Let me repeat. Only population wide immunity will stop the spread of covid19 and end the pandemic. As you mentioned theres been an unprecedented effort to develop and apply vaccines for the u. S. Population and around the globe. This has been extraordinary and marked by collaboration, innovation and speed. The focus of todays previous how we ensure all of this result in vaccine settable safe and effective. In addition to good science which is always a good starting point, i would suggest there e three crucial elements that a fundamental to the success of this effort. No shortcuts, transparency, and trust. Let me elaborate briefly. The development of successful human vaccines is a complex and lengthy process. In response to this emergency a number of steps have been taken where steps can be taken in parallel rather than in sequence to shorten these timelines without sacrificing a thorough assessment of safety and efficacy. The fda is to be committed for publishing a detailed guidance document on the development of covid19 vaccines. Guidance like these while directed industry are really for all to see so all considerations go into the process. But theres where the pressure to rush these vaccines to the American People at warp speed may be well intended, they have well intended but misguided desire to shorten those timelines. Shortcuts could shortchange the process and we all know that cutting corners comes with a price. The consequences of such a misstep or such as a failure to detect safety signal that wasnt expected would have serious implications. Not only to the risk of people, we risk much more that trust the American People in the very process we have come here to discuss. A recent poll found only half u. S. Adult population would take covid19 vaccine. A third are not sure and what if i say absolutely not. These results are a window into the conference the American Public ask about this process. In 1972 Congress Passed the federal Advisory Committee act which lists are best experts of either independent advice to government and these needs are open to the public and because transparency is an important element in the trump equation i strongly recommend any vaccine that is being considered for any type of approval by the fda be reviewed and open Public Meeting of sbas vaccine and related biological product Advisory Committee. As a past participant i can assure you about the robust discussions that they would have. Without such a public review i have no doubt stories will appear about vaccine approvals made behind closed doors because the government didnt want the public to see what or whom men influenced those decisions. Though stories are impossible to stop and the best edit it would be some shocker while we are to talk about the processes in place to make a vaccine would be safe and effective we should also acknowledge were here to talk about trust trust in research and Development Process in which the vaccine licensure is come trust in a vaccine policy process by which a vaccines are recommended come trust in the provider recommends and administer vaccines, to the patient and trust once vaccines are used broadly in a population that there is a system that continues to assess the safety and effectiveness. In the end, americans want to know and understand what the process is and want to be assured the process is being followed and not shortcircuited. They need to all this to build trust and confidence so when they come to weigh the decision of the benefits and risks they will choose to be vaccinated when a vaccine becomes available. I have no doubt when a vaccine is available, the Vaccination Campaign in use would be visible to all americans. Given some of the frustrations and delays and critical of its of the Pandemic Response to date lets not repeat that pattern. Its not too late to put up plan in place and community to all people want and need to know. People are tired of hearing were building the ship before sailing it. Lets build a, finn sailor. Nobody wants it to sink. In conclusion the guard rails to ensure a and effective vaccine beyond compliance rosary to a skunk whats not assure a Successful Campaign that will then end this pandemic. There must be transparent in the vaccine developed developer pr. There can be no shortcuts in and trust must be built and rebuilt among the government, Vaccine Developers and the public and when you do get started on these matters. Thank you. Thank you, dr. Gellin. Next i would like to recognize dr. Goodman. You have five minutes. Can you hear me now . Okay, great. Good morning, chairman krishnamoorthi and other Committee Members. Im an Infectious Disease physician and professor at georgetown. I was formally fdas chief scientist and director effect d lead many Public Health responses. Before that i directed center for biologics evaluation and research, the resident that assesses and monitors vaccines for the u. S. And news. I do appreciate the opportunity to be here today. Public health measures, diagnostics and treatment can save lives but only vaccine offers a potential provide widespread in the and stop this outbreak before it simply turns to the worlds population. For this reason there unprecedented effort to accelerate Vaccine Development that weve heard about. However, vaccines veltman and manufacturing are complex, success is never assured, and while we can speed the process, we must not cut corners. We must ensure any Covid Vaccines are safe and effective and maintain public trust which is already to do so fdas independent should be protected and agency must uphold be transparent about its standards and scientific decisionmaking. In a recent article colleagues and i outline four safeguards needed in covid19 Vaccine Development. First, we need strong evidence of effectiveness. This is best accomplished in a large controlled Clinical Trials involving thousands of individuals that compare rates of illness in vaccine and control groups. To ensure vaccines work and those who need the most come trust must include diverse populations as well as the elderly and those with chronic conditions. Fda recently published guidance that vaccine should be a least 50 effective for reasonable starting point. Its important to emphasize that effectiveness of the cove vaccine is not a given as it is not easy to make that vision against other coronaviruses, and immunity may wane quickly. Second, we need strong evidence of safety. Unlike treatments even to the sick, vaccines are given to te healthy and must be extremely safe. This is a novel disease for which we have no vaccine precedent, and many candidates are based on novel technologies not yet utilized in input vaccines. To ensure the benefits outweigh risk, preapproval safety databases need some without individual. Once safety and general population is document, studies should move ahead, given the risks they face of the roles in healthcare and others such as essential workforces. Third, we need to be very thoughtful about any Vaccine Access prior to approval. There may be circumstances where the use of unapproved vaccines would be appropriate in a severe outbreak. For example, a vaccine with doctor safety and promising effectiveness were available but all the data needed that yet samiti, fda could provide access to an expanded Access Program or in an emergency is authorization for either way. The uas are designed to enable threats or responses in Public Health emergencies that have a lower evidence requirement and fdas normal safe and effective standard. That is that a product may be effective and that likely potential benefits outweigh risks. However, its the same as an approval. As a vaccine use turns out to be an effective array safety concerns, and users are unclear the vaccine was not approved, a crisis could occur undermining confidence in all vaccines. Therefore, if a vaccine issues before approval, we suggest informed consent be part of the process even under the uae and target those at highest risk of infection and applications. The final safeguard is a robust Monitoring System to track safety of vaccines are rolled out. Very serious not be detected in preapproval studies come also when a vaccine at is ministered [inaudible] after vaccination but its critical to be sure they are not vaccine related. For the 2009 h1n1 pandemic vaccines, the system captured government and private sector data was stood up and track millions of vaccine doses. We need to such assess it in place now, not later, with global and full transparency about how safety will be monitored and communicated. In conclusion, while working to get Covid Vaccines quickly, these safeguards are required to ensure they will be safe, effective, and trusted. Thank you and i look forward to the discussion. Thank you, dr. Goodman. Next, dr. Karron have i pronounce your name properly . Yes, you have. Okay. You are recognized for five minutes. Thank you and good morning, mr. Chairman and Committee Members. My name is ruth karron. Im a pediatrician trained in Infectious Diseases and professor at Bloomberg School of Public Health where i lead the center for Immunization Research in the Johns Hopkins of vaccine initiative. My work has focused on respiratory virus vaccines and vaccine policy and ethics. With respect to covid19 vaccines, im on Moderna Vaccine trauma likely be a coinvestigator for two other vaccine trials scheduled to begin this summer. I also had the honor and privilege of serving on two federal Advisory Committees. I served as chair of vrbpac and also served on h the cdcs Advisory Committee on immunization processes. More than 3 million americans have been infected with virus cov2 and more than 137,000 have died. This virus has profound affected us all but has been especially devastating for the elderly, the poor and for racial and ethnic minorities. The government and a plate of covid19 vaccines is essential. Since vaccines will be our best tool to control and ultimately end this pandemic. This is not a competition but i guess and moment. Testing multiple vaccines no increase the chances that would have effective vaccines in sufficient quantity for people in a country and worldwide. We need to make sure the diverse population are included in vaccine trials so we have the necessary safety and efficacy data to inform decisions about vaccine authorization licensure in juice. We also need to plan for the careful, open, and transparent evaluations of all trial data. So we can use of these vaccines safely and effectively to protect all members of our society. Our advice will be critical as the fda reviews vaccine trial data and makes decisions about emergency use authorizations and licensure. Vrbpac input on trial design come review of trial data and recommendations for licensure are two very important purposes. The public and the fda has the opportunity to the thinking questions and concerns of some of our countries leading independent vaccine scientists. Equally important, the fda and vrbpac members have the opportunity to hear and respond to public concerns in an open public forum. This fall and winter safety and efficacy data will be emerging from covid19 vaccine trials. As dr. Goodman just described, decisions may need to be made about issuing one of our vaccine with data that are promising but incomplete. Questions about risk and benefits either for entire populations or for high risk groups us be discussed by burbach using all available data with clear acknowledgment of what is known and what is yet another vrbpac. This is about licensure must also be made with vrbpac engagement, review and advice. We also need to make certain that vaccine safety and efficacy information reviewed by fda and vrbpac is representative reprer society which means trials must include volunteers from diverse racial, ethnic, geographic, and age groups. And work urgently to communities, build trust and ensure that the vaccine is readily available. We must also have a clear plan to meet the needs of pregnant women. Recent c. D. C. Report that pregnant women, particularly black and latino women for icu admission. If we dont have at least one vaccine to offer to pregnant women then we cant protect all of our essential workers because pregnant women are doctors, nurses, emt, police, teachers and nursing home aides and grocery workers and factory workers. We need for systemic Data Collected for vaccine trials, require vaccine manufacturers to perform studies as needed and engage doctors in obstetrics and design studies to include pregnant women. Building confidence in covid19 vaccine is essential, because the best vaccine wont work if it isnt used. We must provide open, transparent and independent expert review and analysis of Clinical Trial data and the decisions for licensure and emergency use authorization. Thank you, and i look forward to your questions. Thank you so much, dr. Karron. Next, dr. Swartz. You are now recognized for five minutes. Good morning, chairman, and members of the subcommittee. My name is david swartz, assistant policy and management at yale school of Public Health. The association of my research in policy, policy making and in development of vaccine regulations, financing, promotion and delivery by government Public Health agencies. My primary message for todays briefing is as follows were facing a Public Health crisis unlike any that anyone alive today has experienced and the speed and urgency around Vaccine Development is simil similarly unprecedented. However, the closer that our Government Agencies adhere to their time tested processes for the effectiveness of the covid19 vaccine and evidencebased development for deployment, the more confidence the public can have in those vaccines and likely that covid19 Vaccination Programs with the incredibly High Expectations placed upon them. This is no time to improve sayings. In the United States we are having a rigorous program for the vaccines, and evidencebase guidelines for use. This expertise presides within the Biologic Research for immunization and respiratory diseases. They have unrivaled expertise regarding the work for covid19 vaccine that lies ahead. These activities can be supported by the longstanding expert Advisory Committees for decades have supported the government regulatory and policy making work around vaccines. Im referring specifically to the vaccine and biologic products, Advisory Committee on fda and Advisory Committee at fda. In supporting the core regulatory review of vaccines, pharmaceuticals and other products. These committees provide the fda with access to preeminent scientis scientists, and regarding the actions the fda should take, Advisory Committees expand the thoughts for perceived legitimacy of their decisions. While fda is not required to follow the advisories it often does. The transparency of Decision Making in accordance with the Advisory Committee act, Advisory Committee meetings largely take place in public and public and stakeholders to see evidence regarding the safety and effectiveness of products who observe Committee Deliberations and comment directly to the staff who participate in the meetings. This kind of transparency can be extremely helpful in alaying concerns about the fda decisions and recording interference and Decision Making. With respect to vaccine, they have been an active contributor since creation in 1981, as my colleagues on todays panel can see firsthand. As covid19 vaccines move ahead in developments. These continue to have the balance of the work in insistence there can be no compromise with the safety and effectiveness expected of any vaccine in order for it to be authorized or approved for use. Its encouraging that they have thus far appeared sensitive to the challenge and this responsibility. There are extremely difficult scientific policies ahead involving the use of covid19 vaccine. Questions that will benefit from more eyes, more perspective, more expertise, more institutional knowledge, more transparency. Not less. And adhering to longstanding policies and norms for safety and effectiveness of vaccine in general and in specific populations, including the participation in the meeting and deliberating openly for decades, will help the Decision Making. The Public Confidence in vaccine is fragile and undergo a threat in recent years, and a process no matter how rigorous to eliminate the possibility of unfavorab unfavorable after its widely approved and administered. In the months ahead to greatly reduce that. The emergence of safety concerns of a covid19 vaccines or that corners were cut or political pressures, to the efforts and confidence in all recommended vaccine and overwhelmed Public Health and Health Systems cannot bear the burden of simultaneously battling covid19 alongside outbreak of measles, influenza and other vaccine preventible diseases in the months and years to come. Thanks to the member of the subcommittee for your interest in these issues and to participate in todays briefing. Thank you, dr. Swartz. Now doctor, youre not recognized for five minutes. Thank you. So good morning, chairman, and Ranking Member and other Committee Members and thank you for the opportunity today. Im a Health Economist and a professor of medicine and economics i have 20 Years Experience working on economics in Infectious Disease with many published papers on [inaudible]. In addition to my Academic Work i work closely with cms on issues related to physician payment, access to care, quality of care, and worked for the last several years with the fda with the center for Biologic Research on biologic products including safety. Today i want to address two topics related to Vaccine Development in the context of covid. First, the safety of the vaccine probably under development and second the policy mechanism to prioritize access to vulnerable population should they prove safe and effective. So, as the other experts said, as we all know, the development of vaccines have proceeded in a report released just yet. The World Health Organization by 23 vaccines with clinical evaluation, and 137 vaccine candidates for clinical evaluation. The vaccine candidates have traditional and novel with the same goal of producing the same antibody response to neutralize the virus and for the covid infection. This is, in my experience, scientific effort in incredibly short period of time and thats the challenge for the covid19. The rapid vaccine candidates naturally brings with it worry about the safety. These arent idle worries because theyre biological agents and need to be tested thoroughly in a wide population. At the same time even discredited challenges of the safety of vaccines like in the case of the vaccine to leave many people to avoid vaccination, so i want to on this point, make address two things to address you and the American Public about the process that the vaccine that the fda will follow. First, in my experience working with the part of the fda evaluating the safety of the vaccine candidates, for several years, i found the fda scientists and works on biologics and drug safety to be among the those conscientious ive encountered. They follow the data diligently and Decision Making. They dont they will look at the data and they care deeply about it. The fda, in the last on june 30th issued a set of a set of guidelines for industry regarding what they expect to see from the trials that are going to be run regarding the vaccine. Among the sets of guidelines include rigorous standards about safety, rigorous standards about effectiveness. High effectiveness standards, against the trials and thousands of people enrolled in each trial for the statistical standards. Traditionally requires at least 3,000 people and i expect more than that. Many, many more than that for this trial, for these trials. Of course, they cant mandate that industry follow these standards, but where the fda will be evaluating trials on a basis of whats reported. In addition to the standards and the june 30th guidelines put out by fda would say that they the population is elderly folks, elderly populations, people with chronic diseases, and people with pregnant women, minority population all must be enrolled in sufficient numbers so its affected in their populations during the trial. In addition to the trial, if the vaccine candidates proof safe and effective, there are extensive markets available in the june 30th guidelines and also, in the traditional practice of the fda that monitors the safety of the vaccines after they have been approved and put in whenever you have a vaccine approved thats used by millions of people, you naturally would expect that there would be some signals you can find outside that the fda will Work Activity to assure that those will be found. The last thing i wanted to address is the the last thing i want to address is the operation work. As you know, this is administrations plan for the developments and efforts for the Covid Vaccine. Two parts, one to provide the safety and efficacy for the vaccine candidates and acceleration of the Development Efforts for the vaccine and then to make financial commitment to the large Scale Production of vaccine doses even before the regulatory process regarding approval is complete. The main thing i want to emphasize about the first part, the studies will be conducted and evaluated by the regulatory process. Cutting corners on safety evaluations. The second part with the vaccine doses before its complete in a sense is a gamble. What if we have the money and then doesnt work well. The other is the vaccine works and tens of millions of doeses and wont a huge gamble given the huge amount of inaudible i think these in a sense, the operation warp speed is independent of the fda process. And thats completely independent. What it does, it avoids the fight over who gets the vaccines first, and the fda process makes it so that we understand if the vaccine is safe and effective and if its not, it will turn out to be a wasted investment, just like any gamble, you have to if it works out right, then it works out wrong, you lose. The loss is much smaller than the potential gain if the vaccine turns out to be good. Let me finish with a last bit about this is only my own two cents, should get the vaccine first, who should get the vaccines first. Theres enormous Clinical Evidence to suggest the elderly and people with multiple comorbid conditions are at the highest risk of covid19 infection. I believe these groups should be prioritized for the vaccines. Operation warp speed will make it so that the fight over who gets the vaccine should the vaccine proof safe and effective would be less of a politic political less political harm. Theres been a lot of political clash over issues regarding covid19 and he think all americans will celebrate together if a vaccine is developing. I believe that operation warp speed will make that a celebration rather than many other aspects. I hope the vaccine comes soon and i appreciate the process. Thank you, doctor. And thank you to all the witnesses. Now we will begin the q a. And as a reminder, each member will have five minutes to do their questioning and well try to observe that so that all members can ask their questions in a timely manner. Once recognized, please wait for confirmation that youve been unmuted before asking your question. Several times ive seen in the past people Start Talking before anyone can hear them and it looks like a silent movie. So, we dont need that. We will try to wait before starting the questioning. I would like to first recognize myself for questions. Dr. Karron, you talked about vrbpac, this sounds like some obscure, strange committee in the government, but as someone mentioned, it was created when president Ronald Reagan first took office and been around for 40 years. Please introduce us to vrbpac, what kind of people sit on this committee and what is its reputation . So, its reputation, maybe ill begin with that, is really providing unbiased, careful assessment of data and communicating that to the fda and to the public. Typically, members of vrbpac are have a wide range of expertise, it ranges from basic science, pediatrics and internal medicine, biometrics, they come from academia and may come from public background. It sound like one of the biggest positive aspects of vrbpac is that it has public deliberations so that theres wide scale understanding of whats going on. Would you agree with that sentiment . I completely agree. And i think its its both that the public can understand as a twoway process and the public can make their concerns heard because it could be that vrbpac members or the fda have not yet heard what is really concerning the public. Very good. And would you agree that vrbpac should be engaged for the process thats 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 which is im extremely concerned that the fda may choose to prematurely grant an emergency use authorization also known as eua, to a vaccine for covid19 just like it did for hydroxychloroquine, a decision that the fda later revoked. Weve heard about operation warp speed, but im concerned about eua being handed out at warp speed and certainly, in the context of covid19 vaccine. Dr. Goodman, under current law, does the commissioner have the authority to issue an eua before the completion of the stage three Clinical Trial . Yes, the regulations around the emergency use authorization are extremely flexible. They certainly require Public Health emergency thats declared at the secretarial level and then fda assessment of the science that should be independent that says likely benefits of using a product or otherwise needed are likely to achieve so theres a lot in there. Got it. Dr. Swartz, do you think that an emergency use authorization should be issued before the completion of the stage three Clinical Trial . I would be concerned for the reasons dr. Goodman mentioned in that a emergency use optionoption optional understood and moving forward with a vaccine without the evidence that we have to have on safety and effectiveness would be taking a very serious gamble so i would be concerned about that as the general public. And you would be concerned because you think it would be potentially dangerous . I think that wed be moving forward with less evidence than wed like to have. With vaccines, the importance of clear confidence in their safety is paramount and they would move forward with we have certainly, then we would expect for full approval. So youd have a strong preference that the vaccine go through the full approval process, including vrbpac, therefore any kind of eua or any approval were granted. Yes, id like to see vrbpac, if it were to be considered, vrbpac should be part of those conversations as well. Theres a place for them no matter which path the fda may consider in the months ahead. Doctor, based on what we saw based on hydroxychloroquine, do you have any concerns about the issues of euas here . No, i think the fda, show us the data, thats what this is go. The phase three trial that you heard is the robust opportunity to take a look at a large segment of the population, thats whats needed to make a responsible decision. Got it. Dr. Karron, one last question. There have been reports recently that convalescent plasma with covid antibodies before they get the coronavirus and dr. Fauci recently called an an attractive concept. Do you think they should be exploring convalescent plasma even before the vaccine arrives . I think it harkens back to my yes and comment. It not only applies to the vaccines, but a multiple counter measures. Whether plasma or antibodies, theyre promising and yes, we should pursue all of these. Very good, my time expired. Let me recognize, i think Ranking Member cloud is still with us. Yes, sir. Can you hear me . I can hear you, i cant see you yet. Hello, hello. Oh, there you are. Mr. Chairman. I recognize you now for five minutes of questioning. Thank you, chairman. I appreciate it. Thank you so much. Thank you all for being here, appreciate your time, your research, your years of service in science and for being here today to help us out with this. Doctor, has operation warp speed eliminated any steps in the vaccine approval process . Not to my knowledge. Not to my knowledge. Its my understanding that operation warp speed has enabled a speedier process by simultaneous simultaneously running through the process of Clinical Trials to help us get to the vaccine quicker than normal. Is that your understanding . Yeah, thats my understanding as well. It basically allows the process of manufacturing and the trial process running parallel. Where for the usual process, you have to run the trial first and then do the now, im sure you could probably take 45 minutes on this, but for a record and public view, can you compare and contrast what the normal process is versus what the administrations approach is in this time . The normal process wouldnt involve federal investigating r d directly, theyve done with the operation. The normal process would involve basically trials just like were seeing with the vaccines that are currently the normal process would involve fda guidance to manufacturers about those, just like weve seen in the guidance, the various guidance applied to manufacturers about what they expect to see in the trial. A normal one that wouldnt say, at least 50 efficacy. Thats extraordinary. Thats a higher standard than normally would be expected. I think because of the fda the fda has signaled, i think, very clearly that they expect High Standards for the vaccine. Focused on efficacy and safety and the june 30th guidelines. Thats beyond normal. The normal process wait and see, imagine a business if the wouldnt say im going to start manufacturing this product before i see it could work. Operation warp speed makes that happen. Lets start manufacturing those products even before we know they work. And the vials and needles and such, right. And actually the product itself. Right. And so if it doesnt work, its investment wasted. If it does work, it exactly speeds up the ability to deploy the vaccine at scale. And youre a Health Economist, part of the lengthsy process is for companies that minimize financial risk and the administration prioritizing saving lives over strategic financial risk is the goal here, is that my understanding . Thats absolutely the goal of the operation. To make it so that were that the public is essentially providing incentives for the drug manufacturers to do the studies, to do the work carefully with the regulatory process to make sure that the thing was ultimately is safe and effective. If it is, then its ready to deploy. If its not, then, okay, we made a gamble and we lost. Dont make the gamble, we produce the vaccine that works, and then many, many lives are lost. Again, youre a Health Economist so theres been a tendency sometimes in dealing with the seriousness of covid to look only at covid and not in the context of dealing with the covid, but also the other impacts of lockdowns and shutdowns, can you speak to some of the other Health Implications that were seeing . Sure, i mean, weve seen an extraordinary increase in the number of suicides. The lockdown has Health Effects that many, many people, weve seen delays in basic treatment, essential treatment, including vaccines, as other vaccines. Weve seen delays in cancer treatment, cancer basic essential treatments have been avoided, i suspect over the long haul, were going to find a big increase in other Health Problems other than as a result of the lockdown. Time for one more question, i know youre a scientist not a political scientist. I know the politicalization of getting a vaccine sooner rather than later. Suredly thered be a benefit to saving lives sooner than later. Do you think theres also potentially an incentive for some to delay a process politically . I would hope not. I mean, i think this is maybe im naive. And i would hope that people come together and say lets look at the data and see if we have an effective vaccine lets get it out to the public as soon as possible. I agree. I have a lot of confidence in the data and evaluate it fairly. Thank you very much. I agree. I do believe, i think hopefully all of us can agree that the data should drive the process. Thanks so much. I yield back, chairman. Thank you very much. Ranking member cloud. Now id like to recognize chairwoman maloney for five minutes of questions. In this hearing today, i want to thank all of our panelists for your dedication to science, for all of your hard work and being in our panel today. Our operation warp speed has promised a safe and effective Coronavirus Vaccine will be approved and 300 million doses will be available by january 2021. And while they are all so eager for a vaccine to be developed and deployed, i am trouble by reports that there may be some political pressure on the fda to cut corners im encouraged our panelists say they do not believe that. But ill ask what problems would there be with cutting corners bringing that to market. Doctor. Thank you. Weve heard a lot about the processes of Vaccine Development and as weve just heard, that part of the lengthy process is to reduce the financial risk. So i would think, everything that should be, can be done to collapse that time without reducing the without minimizing itself. As i mentioned, the process that we need to make sure that all the data that comes from the Clinical Trials is thoroughly investigated in terms of the immune response, effectiveness and particularly the assessment of safety. And im worried in the rush that we might miss something that well look at in retrospect and we cant really afford that. As a followup, how can we maintain an expedited timetable while completing all the steps needed to ensure a safe and effective vaccine . One of the comments that dr. Goodson made was the process put in place 10 years ago h1n1 data as it occurs. Its as the unfortunate name vaccine Risk Assessment group. Every month it had a public process everyone could see what theyre looking at. Things like that are important so the public can see what the scientists are seeing and to see if there are any signals. Thank you, thats a good recommendation. Its imperative that safety comes first in Vaccine Development and once a safe vaccine is developed it must be deployed in a way that ensures an equitable distribution for acceptability and affordability for all people in our country and last month the subcommittee chairman and i wrote to hhs to look at contracts with private companies for vaccine diagnostic. And theyre investing billions of dollars in research. We requested the contact to better understand whether they include provisions to ensure affordability and profiteering to the expense of the American People. And we continue to press for this. Dr. Swartz, id like to turn to you. What must be done to ensure that everyone in the United States has free access to the Coronavirus Vaccine . Thank you, chairwoman. Yes, i think that would be right. Even after we overcome the scientific hurdles in Vaccines Research and development. There will be a tremendous look at distribution for the vaccines that will have much in coordination and leadership to think about the issues around deployment and we have particularly at the centers for tease control and prevention, a parallel group of experts with years of expertise to think about the allocation and distribution issues and we need to make sure theyre with power and that the government has the resources to purchase and deliver the vaccines at the scale we need. And theres a tremendous amount of work that lies ahead if and when were lucky enough to have a vaccine that shows us the kind of profits. And youre saying that the federal government is already planning and investing its resources now to ensure that a vaccine is deployed successfully . Im not so sure about the level, but i do know that expert advisors at the centers for Disease Control are thinking about the questions around prioritization in terms of how we might think about where the first dose is when we know we wont have nearly enough to meet demand and where the first dose, that has moved forward at least at the conceptual level more than thinking and planning, it will be the sources to scale up Vaccination Program and once we have the vaccine, theres a lot of work and assessment required. And finally, once the vaccine is deployed, we will need to continue practices social distancing and looking at whats deploying, is that correct . Absolutely. The vaccine will be an invaluable supplement in the tools that respond end the story in terms of how we respond to covid19, but it will be a very valuable tool as we try and maximize the benefits of the vaccine and maximize with the vaccine thats promising adjunct to the public respon response, and we know in closing. I thank the chairman and all of them once again for your leadership, and i thank you, chairman, for holding this briefing and i yield back. Thank you, chairwoman maloney. Next we are going to recognize congressman grossman. Are you with us . I thought i saw your now am i on . I hear you, i cant see you next. Okay, here, just a minute. Well see if this will get it on here. Let me see. There, just a minute, have to go with me without my face. Let me see there, does that work . No, doesnt work. Not yet. Should we there i am. Do you see me now . There you are, yeah, weve got you. We see you. Okay. Youre so im going to start off by questioning something you said. Youre recognized for five minutes, go ahead. Thank you. You start off by saying we have to, you know, go with the experts and my concern with that frequently the experts vary. Right now in the United States we might spend the most for health care than any country in the world. Certainly more than other westernized nations. I think we take more medications than any other country in the world and despite that, our Life Expectancy is not necessarily higher than other countries. In other words, i think a lot of in this country the expertsing getting things wrong and talked about pills and procedures and we seem to have almost 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 . At least in this state they told people to stay inside. I read experts saying theyre outside, go for the fresh air and the sunshine. I think they were overusing ventilators. I think they way overestimated the number of deaths. At least in my area, they were cleaning out the hospitals. You couldnt get what with were considered to be elective procedures or that sort of thing, many of which were life saving, i think and i think a lot of experts may say people died because we werent doing certain procedures in hospitals waiting for this deluge of patients that never showed up and quite frankly in my district, nurses were being laid off because, you know, the hospitals were emptied out. So, i want you to remember throughout this experts agree and that the Public Health establishment screwed up a lot in this right now. In my district the people i talk to, the more thoughtful people will be jaded about anything they come up with. But im going to ask in general, ill come back to this idea, emptied out the hospitals and couldnt do a lot of things. We have some members. Panel. Could you tell us how the Public Health establishment screwed up there . Do you believe they do screw up when theres so many things they werent doing in hospitals at that could be life saving in anticipation of this big deluge of patients . And why should what should i tell the people back in my district when theyre going to question the experts forever because theyve been given so much bad advice from them in the past . The question ill try to address that. I think the in the earlier days of the epidemic, there might have been uncertainty, for instance, the death rate from the virus. The early models had the virus as way more infectious than it turned out to be. And as a result, the lockdown, i believe, has been early than should have i think the lockdowns are an important tool in some places where hospitals are overrun. As you note, in many, many parts of the country have seen bankruptcy at hospitals that have been emptied out waiting for patients of the virus that didnt come until later. So i think the experts made enormous mistakes early on and i think a lot of the is warranted. I dont believe that we should stop the [inaudible] i think we continue to look at data. The experts disagree part of that. So should be acknowledgment that experts disagree. Okay. Just one other comment and then ill let you guys go. Right now somebody gave me a book plague of corruption by judy sometimes very pro vaccine and sometimes jaded about vaccine. I think there are five people on the panel and no one is it cannily jaded to the degree which she is. I wonder if they feel that somebody like her should be on the panel today or be in the room as we rush vaccines to market . Could somebody comment on her or do you think it would be good to have somebody on the panel like this who maybe things were overvaccinated in america and isnt going to be so gungho vaccine everybody . We can ask you again. Yeah, i dont know her in particular. But i think that i think that the best data out there and having the transparency of what those data are, what the decision is based on, and an open public debate about it. A lot of i think intelligence, well, we read a lot, are sometimes jaded on the vaccine thing and im a little the panel is go, go, go. If i could, congressman just comment briefly. I think youve heard weve had there are concerns about vaccine safety because there are legitimate concerns and we want to be sure that everything is done so that vaccines, when vaccines are available, theres confidence theres been a process in place that ensures that theyre safe and effective. So, even on this panel, we have been quite clear of our concerns that everything be done to ensure those things. I think the other comment is you want to i have to jump in. Were kind of going over here, but the witness can finish the answer. Just one last comment, that what were seeing is extraordinary. Weve never heard of this virus six or seven months ago and now an unbelievable amount of science. We still have many questions, but the amount of science thats come forward has been remarkable, but watching science in realtime can be confusing because every day you learn something else, you take a step forward, a step back, a step side wards, so we need to continue to look at that science and look from a distance as we can, but i agree looking at it every day makes it confusing on one study seems to say one thing and one says the other and we need to assemble the best data to ensure where we are. Thank you very much for that line of questioning. Let me turn it now to congresswoman presley. You have five minutes. Thank you, mr. Chair for directing our collective focus to this critical issue. I want to thank our esteemed panel of experts to assure that our conversation is rooted in science, in Public Interest and equity. And its as a side bar id like to go on record in dr. Fauci i trust. Today im reminded of doctors of a doctors solemn promise, hippocratic oath, do no harm. If we develop a safe vaccine our health must be with that principle, do no harm. Unfortunately the current occupant of the white house has cut corners at the expense of others. And we cannot have those ethics to guide our medical community. This pandemic shows the deliberate process that values equity and inclusion. According to data released by the c. D. C. , black and latinx are hospitalized more. These are the same underrepresented in Clinical Trials. And the manufacturers hope to end the harm from covid19, its critical that those that are hard hit. The United States hopes to emerge from the pandemic and every step of the process must be fair, inclusive and equitable. Doctor, during the covid trials why is it important to include volunteers from Diverse Communities . Weve heard thank you. Weve heard a lot about the size of the Clinical Trials, which is really important. Because its the size of the trials as you heard from dr. Goodman and dr. Karron, allows you to look at population segments in that. Youre going to be recommending a vaccine and well discuss the order. We want to make sure that they work and are in the different populations. Unless you have specific numbers of each of the subsets, you may not have confidence in how theyll perform when used more broadly. And of communities of color, how are communities of color typically engaged in the vaccine process . And others will elaborate, maybe dr. Karron who is doing the Clinical Trials all the time may want to comment, the vaccine process obviously involves people. People are included as volunteers in studies and that can be a challenge when volunteers do or do not want to enroll. In this effort there needs to be a special effort when we look at the broad swath of the population, that the Clinical Trials include representatives for those populations, so, that well have the information on those segments. Whether im sorry, do your point now, i do want to call on dr. Karron. Equity has to be in everything, theres real fear based on history, if you look at henrietta of the tuskegee experiment. What are doctors doing now to ensure we have the data from underrepresented groups. So i can speak to some of the work in particular that warp speed is doing and the warp speed investigators are doing. Theyre engaging now with community leaders, with members of organizations, with potential volunteers themselves to understand what their concerns are and how they can help allay those concerns. And bringing its also very important, there are a few things that theyve identified. One very obvious and they important thing is that some. Study personnel also need to be part of those groups. They need to be approached, as they say, by people who look like them. Another key point, its 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, will vaccine be freely available . So, ultimate access is tied to early engagement. Okay, thank you, dr. Karron and i also just want to he will evaluate the fact that women are also often underrepresented in these trials. So i want to turn to what happens after the Clinical Trials. Even if a vaccine completes phase three trials, there could be insufficient data regarding how it affects at risk populations, black americans, the elderly, those with preexisting health conditions. Dr. Goodman, could the fda still approve a vaccine that didnt have evidence of safety and efficacy . What are the professional ramifications of doing so . Well, i think obviously the intent is to prevent that inherent diverse population in these trials, but, yes, our fda would look at the data and lets say one group was underrepresented, if that could be reflected, to eggs for example, for how its used. Fda could require additional studies after the initial approval so its very common, for example, that certain groups, not just elderly, be represented in the trials. And fda require studies after be submitted. I do think its 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 theyre rolled out to track data on their safety and effectiveness. That will tell us about anticipated problems that might occur in the specific subpopulations. Very good. Well, in closing, i want to say when a safe and effective vaccines is ready to be distributed, i believe it should be widely accessible and available to all. The doctor said in earlier hearings this would be free for all. We must enact an equitable distribution especially to the hardest hit communities. Thank you, i yield. Thank you, congresswoman presley. Now, id like to recognize congresswoman miller. You have five minutes. Thank you, chair, and Ranking Member cloud and thank you to all of you witnesses for being here today. The covid19 pandemic has highlighted many issues that exist within our Health Care System. However, the pandemic has also demonstrated what can be accomplished when we develop Public Partnerships commit tod today committed to vaccines, and for other diseases as well. Im encouraged with the administrations commitment to streamlining the process of a vaccine and treatment while ensuring that safety is above all a priority. Operation warp speed has been a testament to scientific innovation. Doctor, a 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 and good information, but the maybe youre talking about the mmr vaccine and i think that theyre the early, early publication and especially misleading information readily damaged so i think in the future, the vaccine that comes out of this process, i completely agree with my colleagues on this committee that making this making the data transparent and available so everyone can see what the safety concerns are if there are any are critical for the trust of the American Public. Well, it seems like we need to take additional steps to increase the awareness so we can help grow the confidence in the integrity of the decisions being made right now to the potential of these vaccines. Can you speak to the challenges of developing a pharmaceutical vaccine for the coronavirus illness . Its enormous, any vaccine is a difficult challenge. You have to decide what antibody, test whether the antibodies neutralize the virus, all this have before you touch any human. And then once you start putting it into humans, you have to make sure that theyre healthy people, that youre not reducing the response, establish appropriate dosing and all of this happens in phase one trials. Phase two and phase three trials, you test the population, diverse populations, but very important that this vaccine will be widely deployed to see if theres any special concerns in those populations. And the sample sizes of enormous, if theres a signal that exists. And you have to do it for a sufficiently long period so theres a chance of picking up, whether the vaccine is safe and effective. I mean, i think under all of those, in normal circumstances, that would take years. The extraordinary thing thats happening now is in months time, things that normally take years. I think it is incumbent on us as scientists to convey to the American Public what were finding and seeing very, very clearly and loudly in terms that people can understand. So if there is no safety signal, if it is effective we should say that absolutely loudly and not if there is a safety signal and not as effective as we hoped. I have very full confidence that they will say what they find. And the data are produced by companies that are running the trials. The trials are under enormous amount of scrutiny both by the fda and by the public. And theres guidance that the fda put out about what they expect in those trials that include a lot of the concerns that others raise, including the reputation of the population, sample size, looking for signals. I believe, and again, maybe im being naive, but i dont think so. I think well see a lot of information come out and learn a lot about what the infections were and i hate to interrupt you, but i want to make the point when i was a very small child, i remember standing in line at my elementa Elementary School with my mother to get the sugar cube for polio. I have friends that had polio and im 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 needed to ensure that those doses are distributed for all americans across the country. Yeah, and i think that that operation warp speed is part of that so we dont have to fight who gets the vaccine and especially with those doses that are parallel. If the vaccine works and distribute is lively. And everyone in medicare gets it free and if its an essential vaccine that every person with Health Insurance would get it. There are mechanisms in place to allow thank you, yield back. Thank you. Thank you congresswoman miller and now id like to recognize congresswoman tlaib, you have five minutes. Thank you. Are you ready . Yes, i know, im multitasking. So sorry. Thank you so much, everyone for being on this accumulate. I mean thank you for being on this call. One of the things i want today thank the chairman was really to talk about effectiveness and safety. As we all know is that it seems like its a good step towards kind of some transparency and goal setting. But i want to start with the basics. Will a successful vaccine what will a successful vaccine do . And how will the phase three trial make sure that the vaccine is doing what its supposed to do . Thank you very much for that question. I think in the fda guidance, there are several possible outcomes, Outcome Measures that could be attached. I think the most important thing for a vaccine to do is to prevent severe illness and death. And i think and i think the fda guidance does speak to that and say that at minimum must be a secondary outcome and could be considered as a 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 prevented severe disease and death, but still allowed mild disease to occur, would not be a failure. We would count that as success. And what does the fda guidelines mean when they say the vaccine needs to be proven to be 50 more effective and possible 50 its that it must have 50 efficacy. So that, what that would mean is that somebody who was vaccinated would have 50 less chance of having a particular outcome, whatever outcome. And if i can could i just make two comments about that . Because in some ways many of our vaccines are 90 effective and and 80 effective and i think maybe the American Public might think that 50 is a low number. A couple of things to say about that, one is that the frequently what we see with vaccines theyre more effective against worst disease so that a vaccine thats 50 effective against a mild disease night be even more effective against severe disease and the other thing to say if we had a vaccine if wed had half the deaths in this country than what we had from covid, that would still ab major accomplishment. As you folks know, the subcommittee wrote a letter to fda that asked for a commitment of 30,000 participants. We havent received a response yet, i believe, right, chairman . I dont think weve received a response yet . We did . No. One part of the trial design is the number of participants. The fda doctor, what are the risks of having too few people in Clinical Trials. One of the things that dr. Francis cohen and do you agree with them that we need to hit the 30,000 mark . Im sorry, that question is to me or to no, dr. Me, okay. Sorry. Thats a great question. I think they were outlined well on the guidance. I heard from dr. Collins as well. The reason we talked about ments should it be 30,000 is the question. Should it be 30,000 . I think thats a pretty good number. Because thats going to allow us to look at some of these groups in the population in the setting. What we often see sn one of the things that the doctor mentioned that some of the larger communities, when the data comes through, well, you wished you knew more about some group and they need to look at that. Setting that ind coo setting that kind of a marker, you have the group that would receive the vaccine. There are some data from the ct suggest that black latina women may suffer more than other subpopulations of pregnant women but at the very least they dont have milder disease and other adults. Basically deserve an opportunity to be vaccinated just like other segments of the population. Its critical support. Thank you both for your answers and the yield the rest of my time. Thank you very much. Thank you so much. Can you hear me . Great. Thank you so much, congresswoman tlaib. Now we go to con connelly. Are you with us still . Can you see me. Us i cannot we can see part of you. Your i am. All right. You are recognized for five minutes, my friend. Thank you, mr. Chairman. Thank you all for being here. I want to talk about two things. Efficacy and risk. Dr. Goodman, how long does it take historically to develop an effective vaccine . Typically as others have said, several year process, but what were seeing here dr. Goodman, ive ive made is so let me interrupt you. What is the fastest vaccine ever develop . Probably the 2009 pandemic vaccines, but based on influenza manufacturing vaccine design. That was somewhat. Several, okay . For months . Yeah. So, for example, how long has aids been around . Well, hiv, since about 20 years. Actually goes back to around 1980, right . Right. So that 40 years. Thats what he 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 very ineffective so the spanish influenza, maybe thats more of the parallel, that was 100 years ago come making 171918. Do we. Do we have a vaccine today that prevents somebody from getting the flu . We have influenza vaccines as you know. They change every year based on what strains are circulating, and we also develop vaccines against pandemic threats. Maybe an analogy to this is more like Something Like ebola were in the course of very exonerated Critical Development of vaccine was available within a few year years. But the point is, most flu vaccines help with the severity of the flu. They dont necessary prevent you from getting the flu. Fair enough . They do both actually. They are among our less potent vaccines in that they typically reduce risk of an actual infection, depending on the population in the year. It could be 2060 of the are more effective like you said at reducing complications. Right. What a car to get 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 shoring up your immune system so your 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 we have lost sight a bit of what efficacy really means. It isnt necessarily a cure, that the history of cures through vaccines is very limited. Dr. Gellin, risk. Mold enough to remember what can go wrong when you rush a drug to market . That was a simple drug, antinazi for pregnant women to make the more comfortable. A lead to horrible deformities in babies that were born. How do we way riskier when hundreds of thousands are dying come millions are getting infected if we want to try to end that . What risk is acceptable and what risk isnt and how to insulate ourselves politically from the pressure which we seem from this president and his administration to kind of cut corners scientifically already . What confidence do we have weve taken into account risk . If 20 people get back to develop Kidney Disease that seems to be a pretty high risk that would be unacceptable. If 1 of them nonetheless get covid19 that might be acceptable. Could you talk about the . Then i yield back. You have many questions but ill point to the same thing. They. 2 the process of review. They point to the independent sites of the fda brings to this to look at all that data and there are decision the deliberations. Its always about benefits and risk. Nothing is perfectly safe and nothing is perfectly effective here its about us where to look at here. Thats why mr. Chairman, i know i have just a few seconds. Thank you, doctor. Dr. Schwartz, could he be allowed to address will . I saw him shaking his head vigorously. I agree. It is difficult questions, questions the threshold and how much evidence is needed and is a fact and why we need to do for the kinds of structures, expert mechanisms to sort through these tradeoffs in any vaccine prevents in the best of circumstances come all the more so given the urgency of the vaccine here. This is why we have these systems, to address exactly the questions you are imagining like might come down the line. Thank you so much, con cawley congressman cawley. Connelly. I recognize katie porter, congresswoman porter for five minutes. Thank you so much. Dr. Gellin, i am a mom with three kids i want to make the best possible decisions that i can for the health and for the own and for our community. Thats why every single year we all get our flu shots. We wash our hands. We wear masks. Were doing the right thing because i believe in 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 here that im a concerned parent and ive been hearing a lot, the president pressured the fda to approve this new covid19 vaccine. Dr. Gellin, do think i might be nervous about getting this vaccine for my kids if i thought the process was rushed or different than the other vaccines that i routinely and know that are safe for our kids . For the same reasons and that the information that comes from these studies is going to inform that. It also raises the ship where to get your information and who are your trusted sources . I think another layer is while this data is important and very expert communities will review it, its critical that people on the front lines, the doctors and nurses, who are going to be delivering these vaccines and with asking, asked questions by you and other patients also feel confident in the process. They have to know that it was undertaken in a way that, the way those going to bring about the best results and understand what that was, and a need to be the translator of that information. Theres probably no other trusted source in the people you interest your help and your Childrens Health or two. If theyre not part of the solution, they will be part of the problem. 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, are not going to be going through the fda website. They will be googling and they will be on facebook and there will be asking their friends. And youre right to point out doctors and nurses are like my childrens pediatrician has been their pediatrician since it been born on them also worried i will not be getting the shot from the kids pediatrician. I would be getting it from a mass Public Health setting so its important the fda put out that information in an accessible way including to providers that we can reach up to. What happens though if people hear these stories about the processing rush . Im not i dont know, i havent got the usual information that i get. What happens if we are 4050 of the populace gets the vaccine because they dont trust [inaudible] unfortunately, the stories you mentioned already out there. Even before vaccines go to the Clinical Trials. I think the solution or a response is to inoculate against this information to the degree we can which is not easy to do. Thats separate from your question about if not evan gets a vaccine. 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 dampening the disease process, i think that will increase the confidence of those who might be skeptical to say it is actually working, then they rethink a decision they made previously which is why the information needs to be critically 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 sites been Public Health and virus prevention. Wearing something as simple as a cloth mask has become an aggressive debate. Social distancing has become more and more controversial. The science is a period things like wearing mask and vaccines to work or because we havent had a clear decisive message from the federal government about the scientific validity of things like social distancing and wearing masks, a become divisive. So we cannot risk the same thing happening for the vaccine because it so imperative that every person who can get this vaccine once it is developed does so. Is anything more that the fda should be doing with regard to create that kind of Public Confidence for vaccine adoption . I think that we talked and a part of it. There also needs to be an effort to communicate things anyway that people can understand them. Often the language of the experts is not approachable, so we need to be able to translate that the people can understand what it means. We had a discussion a few minutes ago about what they can get all the math behind it but that doesnt necessarily mean that people who hear and understand it. Thank you 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 . Yes. Actually. I want to thank the panel. This has been a very, very enlightening hearing. I appreciate so much a testimony about how we have to balance speed with safety as we pursue these vaccines. I wonder, and i invite any panel the wants to respond to this, if you could compare this Covid Vaccine pursuit with what Many Americans are familiar with, which is the sort of the flu vaccine, and maybe compare it 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, how do you compare that to what you are seeing in surveys about a potential Coronavirus Vaccine . And what are some of the practical dimensions of how we would be distributing Covid Vaccine at the same time we would be distributing the seasonal flu vaccine. So 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 draw some comparisons and analogies there on those various topics . I can address that. So the blue vaccine, the big concern has to do with blood stream of [inaudible] and you have to make best guesses about that but that knowledge to produce the antibody response once you identified what the strange you think will be predominant is wellestablished. By contrast, in this case we dont know how effective the antibody response is going to be from the vaccine. So in that sense more uncertainty around this vaccine than the traditional flu effort. At the same time, the amount of, the number of people in the trials is extraordinary that the fda is requesting. We will have a lot of information about whether [inaudible] so i think its both more and less than certain because we dont know about we know what the virus is, unlike the flu we dont know the strength of the virus but theres less uncertainty about [inaudible] i think youve asked a critically important question. Because as you said, in peoples minds is are similar. We read a lot about the great influenza pandemic. We heard about the parallels, and we expect this to some of be like influenza. Thats an important conversation because there are you just heard some of those. This figure weve all seen about flattening the curve, that cos from work 15 jusco from influenza. You flattening the curve to keep people out of the Health Care System until a vaccine arrives. Because we had decades of experience making influenza vaccines, we knew we could do it. We knew we could get there. It was just matching the strain of the pandemic. This is different. Were flattening the code to keep people out of the Health Care System while we are working on a vaccine that we dont know will work. Thats the key difference. You asked a number of questions we could get into about dissipation, the simultaneous use of vaccine, a Covid Vaccine. These are all very important questions that a think we all need to be working on so there isnt confusion about these. Thank you for asking. I have 45 seconds, if 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 and not compared what youre hearing out there compared to the Covid Vaccine. Is just quickly, half the population gets the flu vaccine the confidence is not all about safety. The conference is about how well it performs. Thats a lot of work thats been done to try to improve the performance of that vaccine and thats the people dont get it its probably because of that and not because of any concern they have about the safety profile. 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 i also want to just conclude by saying we all want a vaccine as soon as possible. I think that goes without saying. And we want to expedite the creation of a safe and effective vaccine, but the only way to do that and i think theres little to the unanimity on this particular point as i heard from everyone on this panel is that we should not cut corners at the fda. Perhaps there might be some effort 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 the anything that would hurt or harm the conclusion that whatever the fda ended up approving is safe and effective. And so i hope that come out of 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 the vrbpac be engaged fully in the deliberations surrounding a covid19 vaccine. With that i would like to thank you all for participating, and this session is adjourned. Thank you. Tonight on the communicators , California Democratic congressman ro khanna who represents Silicon Valley talks about how twitter Ceo Jack Dorsey and facebook ceo Mike Zuckerberg reacted differently to President Trump using their platforms to suggest that could be mail in ballots voter fraud. I wouldve handled differently. I think i dont think thats the main issue. The real is jack dorsey saying Donald Trumps misleading posts about voter ballots and doing that didnt lead less people reading. It led to more people reading the tweet. Do i think dorsey took a better approach . Yes, but i think the question for facebook on civil rights is not how the handling Donald Trumps tweets . Its more broad. How the handling speech that is giving people false information about how to vote . Tonight at 8 p. M. Eastern on the communicators on cspan2. This is the New York Times headline at New York Times. Com after a tight race for the polish president winning a second term. Joining us on the phone from warsaw, poland, is mark anthony who covers all of this as the east and Central European your chief for the New York Times. Thank you for being with us. Thanks for having me. Explain the significance of the reelection of the polish president come what it means for poland and also for the u. S. And the Trump Administration. Sure. I think its probably for your viewers may be worth backing up a bit. This party came to power by kazuko, i populist believe that was sweeping across parts of europe and so much of that five years was broadly popular in part because of ideology but probably more so because of this financial policies which are very generous come social welfare programs. And then before the pandemic it it looked like president duda was cruising to reelection within theth pandemic hit and making an they had to postpone the Russian Election and monday postponed the mayor of warsaw, a young man entered the race i think he surprised everyone by giving a very tight contest. He made it to the run up and he lost the senate by about half a million votes. They each got about 10 million votes. Thats the background. The reelection of the party, some the things theyve done over the last five years that have concerns particularly international observers, of the members of the eu come having to do with changes to the court system, the takeover of state television to make it a propaga arm of thehe government and some of the other troubling law issues those in the event it was a tight race they are not in the driver seat to push through more of those changes. President duda traveled to just last month and met with the president and reporters in rose garden press conference. Heres part of what he told reporters. One hundred years ago we repelled russians from warsaw. And great battle in 1920 we defeated the Army Bolsheviks d d we drove them back. That was a great victory but we managed stopp and only at the outskirts of our capital city. We would never want to see that situation repeated again. That is why the owl at present this Crucial Point today and its a very important guarantee to us and very pleased both of the nato is within the United States today president of the United States understand of europe and he understands the realities in europe and he also understands the situation as it is developing in europe. So to say this generates peace to my country, it bring security and thanks to that, russia is unfortunate a very strong imperial ambitions which have been revives over the last tens of years i can say because georgia was attacked in 2008. 2008. Thanks to those ambitions have been stopped for the time being at least in this part of the world. I have no doubtth whatsoever tht this is also a huge merit of the policy of the traded. I am grateful for that just like all my compatriots are. Through the translator the comments of president duda poland and marc Anthony Santora as you that how does that contrast with other european leaders most notably german chancellor Angela Merkel especially with regard to nato . Well, i think a couple things. One is poland traditionally regardless of party, which of administration, has had a close relationship with the u. S. Military, diplomatic. Whats different in this case is this administration in poland has aligned itself with the Top Administration to a degree that is somewhat unusual. For instance, when theyre trying to get more american troops baster, they said they would name it for trumpet mr. Trump had president duda to the white house before the election of which in a close contest was unusual to say the least. We have seen like putting a finger on the skill. On the level that duda administration of the Trump Administration are on the same page but longterm consequences remain to be seen. More broadly speaking poland in general for the 30 years since communism ended here has had a a close relationship militarily, diplomatically with the u. S. One final point as you look at nato, poland is ninth out of the nato nations. The u. S. Is leading in terms of funding. What, if anything, will change in this administration especially if President Trump ii reelected . I mean, you know, i likely dont have to look to the future. I just try and understand what just happened. A crystalnt to get ball out but i do think President Trump has made his wariness of International Organizations like nato well know. He has been openly come you know, is relationship with the germany has not been a good one. I think it would be a difficult relationship to repair if he wins, not that he would even care to necessarily if he is reelected. With regard to the election that just took place in poland broke with what was a like across the country . It was highest turnout since the first partially free elections were held in 1989. It was remarkable just how energize people were. What was striking was the divide in the voting. Obviously all around the world you have divide between cities and rural areas. Do you saw the age gap where the mayor one people over age of 50 by a large margin and duda had one people over 60 like just a a large margin said a real generational divide which is whats goinghe to be the next story in Poland Politics as we go forth. Marc santora is a east and Central European bureau chief for the New York Times based in warsaw, poland. We thank you e for being with u. Thank you, steve. Today British Ambassador to the u. S. Karen pierce talks about russias influence in uk and europe. The center for strategic and International Studies hosts the discussion at noon eastern. Watch live coverage on cspan2 come on by the cspan. Org or listen live on the free cspan radio app. Former defense secretary leon panetta who served under the Obama Administration testified before a House Foreign Affairs subcommittee on managing threats from russia. The hearing focused on russias use of cyber and