Around the globe, nearly 200 vaccine candidates are being developed and nearly 20 have entered human. Clinical trials in the United States. Entered human Clinical Trials with large Clinical Trials to begin late this month. With the historic, all hands on deck effort underway around the globe come of the timeline to develop a vaccine may be compressed from several years now to just 12 or 18 months. Moving with this amazing speed does not and must not allow for cutting any corners. Today, we will hear how we must place trust in the fdas [audio drop] to produce a vaccine. We in Congress Must do our part to protect their work from political meddling so that they can uphold their professions utmost standards of scientific analysis and ethics. We are not here today [audio drop] not politicians. I want to highlight two guardrails 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. [audio drop] vaccines. [audio drop] a 30,000 trial participant requirement for trials as well as engagement. Haves later and we received no response. Two weeks ago, the fda commissioner said he would maintain his higher standards. Commitment to a 30,000 trial Participation Rate as well as engagement with the concrete ways to guarantee that rigor. We must remain vigilant to the risk it does not follow consumer ratings, theroval impending election and the urine to return to normalcy must not distort the decision on whether or not to approve a vaccine. We must expedite the developing a vaccine but we cannot cut corners in the process. Like tot, i would now recognize the Committee Chair for her opening remarks and thank you, chairwoman maloney for joining us, as well. Thank you to all of my colleagues, but i especially want to thank the witnesses for joining us this morning. To hear from experts about the importance of promoting transparency to ensure the is safe andvaccine effective. We are fortunate to have a panel of Public Health experts before the subject subcommittee today and i thank you for taking time to share your insights with us. I would like to take a moment to dr. Jason schwartz of the yale school of Public Health. I had the privilege of hosting him last week last may in new york city. I am delighted to see you again, dr. Schwartz. Thank you for joining us. Finally, i want to commend the andership of the chairman convening todays briefing to ensure a safe and effective Coronavirus Vaccine is developed and made available to the American People following the protocol of the fda to ensure safety for our people. I am thankful for your leadership and grateful to be a partner with you on this very critical issue, and i yield back. Thank you very much, chairwoman maloney. Im sorry for the delay but it is a way to make sure each of us gets on mute and can hear us when we talk. Now i would like to turn it over to Ranking Member for your opening remarks. Unmute congressman cloud. Hello, can you hear me . , chairman for holding this meeting. It is certainly an important topic as we deal with a pandemic that has ravaged our nation and indeed the world. It is importantly come together and address these Health Issues intentionally. I would note off the top of that, we have the ability to hearings as opposed to briefings, hearings which would follow rules and i would request the majority considers future hearings, that we would conduct them in a format that would protect rights. Congress has provided 3 billion for vaccines, therapeutic, for covid19 through the cares act. The Trump Administration has our countryessly so can overcome the challenges and ensure we find the best therapeutic to treat covid19 and can develop a vaccine in record time. To this end, President Trump initiated operation warp speed, which empowered the government to work with the private sector to manufacture 3 million doses of the vaccine with the goal of having those by january 2021. President trump because of this immense effort that the government and pharmaceutical companies, the u. S. Is on track to have a vaccine available by 2021. D or early this is an incredible feat. In context, the h1n1 vaccine was developed in six months, but relied on 70 years of food flu Vaccine Research. It took eight years to develop an ebola vaccine. The American Public should rest assured the administration and Industry Partners are not sacrificing safety while developing this vaccine. Cornersnot be cutting in the development of this vaccine. Instead, operation warp speed enables steps in the vaccine process to happen simultaneously. It doesnt skip steps, but allows them to be done simultaneously. This increased the cost of production. Companies have partnered together on cost to get a vaccine faster. The federal government announced two new contracts. Both of these companies have agreed the doses manufactured under these products will be owned by the federal government, meaning if the vaccine is proven effective, the u. S. Government would make the dose is available to americans at no cost. Other Companies Like moderna, to astrazeneca have pledged set low prices on any vaccine approved. Between the low prices and existing programs, no one would go without a vaccine who wants one. Insuring equitable access to the vaccine once developed, the cdc has been working since april to develop a ranking system for distribution. Those serving on the front lines like medical professionals, those with underlying are likely and those to get the first doses, ensuring the most vulnerable are protected. I look forward to hearing from the panelists on how we can sure ensure the public trust. Thank you, chairman. I yield back. You so much, Ranking Member. At thiseat to have you hearing and i appreciate your remarks. I think we are much better off when everyone is participating and asking the tough questions, produces a real robust conversation so thank you. Et me turn to our briefers we have five witnesses. Im just going to quickly say toir names and turn it over. He doctors, dr. Schwartz start. Now going to you are recognized for five minutes. There is a timer on your screen and i appreciate all of us sticking to our five minutes, so with that, you are now recognized. Thank you. Can you hear me . Ill look for that timer, thanks. And morning, chairman members of the subcommittee. For the work you have already done to ensure the response to the covid19 pandemic is done with the best science and the scientists. I am the president of globalization at the Vaccine Institute in washington. Make vaccines to more accessible and expanding across the globe. My entire career has been vaccine focused and for 15 years as director of the National Vaccine program. Familiar with the statistics. The virus has taken a disproportionate number of american lives and beyond the obvious health impacts, no while has been spared and the various efforts to flatten the curve, social distancing, handwashing are all important to help control the virus, it is absolutely clear the only population wide immunity will dampen the ongoing spread and the pandemic. Let me repeat. Immunitylation wide will stop the spread of covid19 and the pandemic. There has beend, an unprecedented effort to deploy vaccines for the u. S. Population and around the globe. This is extraordinary and marked by innovation and speed. Is focus of todays briefing how we insure all of this results in vaccines that are safe and effective. In addition to good science, i suggest there are three crucial elements fundamental to the success of this effort. No shortcuts, transparency, and trust. Let me elaborate. The development of successful human vaccines from idea to licensure is a complex prices, but a number of steps have arte been taken already been taken. Timelines without sacrificing safety. The fda is to be commended for a detailed guidance document on the development of a vaccine. These, there is pressure at work speed , may be well intended, may have misguided desire to shorten timelines. Shortchangeuld the process and such a misstep here would have serious applications, not only the risk that people will decline vaccination, but the trust of the American People in the process weve come to discuss. A poll found only half the Adult Population would take the covid19 vaccine. A third arent sure and one in five said absolutely not. These results are a window into the confidence the American Public has about this process. In 1972, Congress Passed the advisory act, committees were the best effort to provide their independent advice to the government and these meetings are open to the public. Transparency is an important element and i fully recommend any vaccine being considered for approval by the fda be reviewed by ann Public Meetings Advisory Committee. Ensurerticipant, i can the robust discussions they would have. Without such a public review, i stories will appear about closed doors because the government didnt want the public to see what may have influence the decisions. Those stories are impossible to stop and the best antidote would be sunshine. While we are here to talk about the processes to make a vaccine safe and effective, we should acknowledge we are here to talk about trust. Trust in the Research Process that leads to licensures, trust in a policy process by which vaccines are recommended. Trust in the providers who recommend vaccines to patients and trust that once vaccines are used through the population, there is a system that continues to assess their effectiveness. End, americans want to understand the process and to be assured the process is being followed and not shortcircuited. To build the trust that has been eroding over vaccinations for some time so when they come to weigh their decision about risks, they will choose to be vaccinated when it becomes available. Ive no doubt when a vaccine is available, the Vaccination Campaign in the u. S. Will be visible to all americans and given some of the frustrations and delays, critical elements of the response to date, lets not repeat that pattern. It is not too late to put a plan in place and communicate to all who need to know. People are tired of hearing we are building the ship we are sailing. But spilled it and sale it, no one wants it to sink. Guardrails to ensure a safe compliance with rules, compliance alone will not ensure a Successful Campaign that will end the pandemic. It must be transparent in the development process. There can be no shortcuts and amongmust be built developers, the government, and the public. Thank you. Dr. Gellin thank you rep. Krishnamoorthi thank you, dr. Gellin. Can you hear me now . Good morning, chairman and other Committee Members. Im a professor at georgetown. I was formally fdas chief scientist and have helped lead Public Health responses. Center forthe fdas evaluation and research, the center that monitors vaccines for use. I appreciate the opportunity to be here today. Health measures, diagnostic treatments can save lives but only vaccines offer the potential to provide widespread immunity and stop the outbreak before it burns through the worlds population. For this reason, there are efforts to accelerate Vaccine Development that weve heard about. Vaccine development and manufacturing are complex. Success is never assured and while we can speed the process, we must not cut corners and insure any vaccines are safe and effective and maintain public trust, which is already tarnished. So, fdas independence should be protected and the agency must uphold transparency about it scientific decisionmaking. In an article, colleagues and i outlined four safeguards needed for covid19 vaccine developed. We need strong evidence of effectiveness, best accomplished in Clinical Trials involving thousands of individuals, comparing rates of illness. In vaccinated and control groups to ensure vaccines work, you diverse most populations as well as elderly and those with chronic conditions. Fda recently published guidance a vaccine should be at least 50 effective as a reasonable starting point. It is born to emphasize effectiveness is not a given as it has not been easy to make vaccines against other coronaviruses. We need strong evidence of safety. Given to theents 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 candidates are based on novel technologies not yet utilized in approved vaccines. To ensure the benefits outweigh risks, safety databases should include several thousand individuals. Once safety is documented, studies should move ahead in pregnant women given the risk they face and the roles in health care and other essential workforces. To be thoughtful about Vaccine Access prior to approval. There may be circumstances where an unapproved vaccine could be appropriate in a severe outbreak. Safetyne with documented were available, fda can provide access to expanded Access Program or to an emergency use authorization. Eua are designed for flexible responses in health emergenciess but have an evidence requirement longer than the fdas normal standard. Andproduct may be effective the known benefits outweigh the risks. Experience has shown the public may interpreted as the same as approval. If a vaccine under eua raises safety concerns and users are unclear it was unapproved, a price crisis could occur. Therefore, if a vaccine is used before approval, we suggest informed consent be part of the process even under a eua and this be targeted to those at higher risk of complication. Finally, a Monitoring System to track safety. Be detected in preapproval studies and a vaccine is administered, common events will occur after vaccination but it is critical to be assured they are not vaccine related. H1 vaccines, the system, tracked millions of doses. Vaccines were safe. We need systems in place now, not later. For transparency about how safety will be monitored and communicated. In conclusion, while working to get vaccines quickly, the safeguards ensure they will be effective, and trusted. Thank you and i look forward to the discussion. Rep. Krishnamoorthi thank you, dr. Goodman. Next, have i pronounce your name properly . Yes, you have. Rep. Krishnamoorthi you are recognized for five minutes. Thank you and good morning, mr. Chairman. I am a pediatrician trained in Infectious Diseases and a professor at Bloomberg School of Public Health were i lead the center for immune is a sure research and the vaccine initiative. My work is focused on respiratory virus vaccines and vaccine ethics. With respect to covid19 on the vaccine trial and will likely be a coinvestigator for two other vaccine trials scheduled to begin this summer. Ive also had the honor and privilege of serving him to federal Advisory Committees. I served as chair and on acip. Americans3 million sarsbeen infected with covid two and more than 137,000 have died. This virus has profoundly butcted affected us all, especially for the elderly, poor, and racial and ethnic minorities. Development and deployment of vaccines is essential. Vaccines will be our best tool to control and ultimately end this pandemic. This is not a competition, but a yes and moment. Testing multiple vaccines now will increase the chances that we will have effective vaccines in sufficient quantity to protect people in our country and worldwide. We need to make sure the populations are included in vaccine trial so we have the safety and ephesus he efficacy data to inform decisions about authorization. Plan for the careful, open, transparent evaluation of all child data so we can use these vaccines effectively to protect all members of our society. Advice will be critical as the data anded reviews makes decisions about licensure. Childhood that a conditions. For licensure are two important purposes. Fda have concerns about some of our countrys leading independent vaccine scientists. Equally important, the fda has the opportunity to hear and respond to the publics concerns in a public forum. Safety and efficacy data will be emerging from covid19 vaccine trials. As dr. Goodman described, decisions may need to be made s for vaccineseua that are promising or incomplete. Questions about risks, benefits for entire populations or high risk groups must be discussed using all available data with clear acknowledgment of what is known and what is yet unknown. Decisions about licensure must be made with engagement, review, and advice. We also need to make sure vaccine safety and efficacy information reviewed is representative of society, which means trials must include geographic, and age groups. We need to ensure black, latinx, and native american populations who are far more likely to be infected and die from covid, have opportunities to participate in the trials but choose to. For this to happen, we must acknowledge the high level of andrust in many communities work urgently to engage communities to build trust and insure the vaccine will be free and readily available. We must also have a clear plan to meet the needs of pregnant women. The recent cdc report indicates ,resent pregnant women particularly black and latino, may be at increased risk for hospitalization and icu admission. If we dont have at least one vaccine to offer to pregnant women, we cant protect all of our essential workers, because pregnant women are doctors, police,and emts, teachers, and nursing home aides, refers for workers, and factory workers. Systematic Data Collection from women who become pregnant during upcoming vaccine trials, require vaccine manufacturers to perform studies as needed, and engage experts in pediatrics and Research Ethics in designing studies to include pregnant women. Building confidence in covid19 vaccines is essential because the best vaccine in the world wont work if it isnt used. We must begin by developing trust in the Clinical Trials process and providing open, transparent, independent expert review and analysis of clinical aboutdata for decisions vaccine licensure or emergency use authorization. Thank you and i look forward to your questions. Thank younamoorthi so much, dr. Karron. Dr. Schwartz, you are recognized for five minutes. Dr. Schwartz good morning, chairman and members of the subcommittee. Professor atant the department of Health Policy and management. At the heel school of Public Health. A focus of my research is u. S. , particularly how evidence informs regulation, financing, promotion, and delivery. My primary message for today is as follows. We are facing a Public Health crisis unlike anyone alive has experienced and the speed and urgency surrounding Vaccine Development is similarly unprecedented. The closer to our Government Health agencies adhere to their wellestablished, timetested processes for evaluating the safety and effectiveness of covid19 vaccines and developing evidencebased approaches to their deployment, the more combatants the public can have in the integrity and quality of those decisions and the more likely it will be that covid19 Vaccination Programs approach the incredibly High Expectations being placed upon them. This is no time for improvisation. Have annited states, we extremely robust and well functioning system for rigorously and continuously evaluating the safety and effectiveness of vaccines before and after their initial approval, and producing widely respected guidelines for their use. This expertise is in the center for Evaluation Research and Cdcs National Center for immunization and respiratory diseases. The scientists have unrivaled expertise required for covid19 vaccines. It can be supported by the external Advisory Committees that have for decades supported the governments regulatory and policy making workaround vaccines. Im referring specifically to the vaccines related to biological Products Advisory Committee at the fda and on immunization practices at the cdc. For 50 years, advisory middies have been intellectual influential in core regulatory responsibilities to the review of pharmaceuticals and other products. The fdammittees provide with access to scientists and physicians from outside the federal government, who offer recommendations regarding actions the fda should take. They expand the expertise available to support decisionmaking and their thoughts to increase the perceived legitimacy. Tole the fda is not required follow the recommendation of its Advisory Committee, it often does. Advisory committees also help to enhance the transparency of decisionmaking in accordance with the provision of the federal Advisory Committee act, meetings occur largely in public and make members of the public and stakeholders opportunities to see relevant evidence regarding the safety and effectiveness of products and absurd deliberation and comment directly with staff who participate. Be helpfularency can and allay concerns about the grounds for fdas decisions or allegations regarding interference in the scientific assessments. Vaccines, it has been an active contributor since its creation in 1981. Vaccines move ahead in development, these efforts continue to balance the urgency of the work with insistence there can be no compromises with respect to the safety and of anyveness evidence vaccine for it to be authorized or approved. The statements from fda leadership have appeared sensitive to this challenge and responsibility. There are difficult scientific and policy questions regarding the ad valuation and use of covid19 vaccines. Questions that will benefit from more eyes, more perspective, more expertise, more institutional knowledge, for transparency, not less. Adhering to longstanding practices and norms for assessing the safety and effectiveness of the vaccines in general and in populations, including the participation of the fda and cdc expert Advisory Committee, deliberating as they enhancingfor decades, decisionmaking and confidence in the vaccine anticipated. Public confidence in vaccines is fragile and has been under threat in recent years. While no approval process can illuminate the possibility of unfavorable evidence after a vaccine is improved approved come in the action taken by the fda and counterparts can reduce the possibility. The emergence of a serious safety concern related to a covid19 vaccine or the perception by the public that corners were cut or political pressure was applied will be damaging not only to covid19 vaccination efforts, but also to Public Confidence in all recommended vaccines and our Health Care Systems cannot bear the burden of simultaneously battling covid19 along outbreaks of influenza and other preventable diseases in the years to come. Thank you to the members of the subcommittee for your interest in these issues and the invitation to participate. Thank you,amoorthi dr. Schwartz. You are now recognized for five minutes. Thank you. Good morning, chairman and Ranking Member. Thank you for the opportunity to speak today. I am a Health Economist and professor of medicine, where i direct policy and economics. The 20 years working on economics of Infectious Diseases with published papers on h1n1, also on sars cov 2. My academic work, ive worked with regulatory agencies on issues related to access to ive quality of care, and worked for the last several years with the fda, with the center provider biological vibration research, including safety of the flu vaccine. I want to address two topics related to Vaccine Development. First, the safety of the Vaccine Development and second, the policy mechanisms that provides access to the population should they prove safe and effective. As the other experts said and we all know, the development of vaccine candidates is proceeding at her markable pace. 23 maxines are in evaluation, 137 vaccines have reached clinical study. They employ a variety of technologies traditional and novel with the goal of producing a sustained antibody response that can neutralize the like in the case of the mmr vaccine lead to consequences of spread. This point i want to say two things to address you and the American Public about the process on the safety of the vaccine. Working withnce part of the fda with vaccine candidates, work at them for several years. On biologics and drug safety is one most careful ive ever worked with and encountered. Diligently. The data and will look to the data care deeply about safety. The fda on june 30 issued a set of guidelines for industry regarding what they expect to see from the trials that are to be run regarding the vaccine. Those guidelines include rigorous standards about safety and effectiveness. And thousands of people in each traditionally it requires police 3000 people and they can expect more than that. Of course they cant mandate that the industry follow the standards. The fda will be evaluating whats before it. The standards and guidelines say populations like elderly populations, people with chronic diseases and pregnant women, minority populations in those populations. Trials thatto the approved safe and effective, this extensive post market surveillance with the guidelines and also to monitor the safety of the vaccines after theyve been approved and put into use. You national would expect there and theydme signals work very actively to ensure those be found. The last thing i wanted to address is operation warp speed. Plan tonistrations accelerate. Provide Financial Support for studies with the most promising candidates in the acceleration. And then to make financial commitments vaccine doses. The main thing i want to emphasize about this will be evaluated by the regulatory process. What if we invest a large amount of money and it doesnt work very well . If it works, tens of millions will be available. Its a big gamble. In a sense, operation warp speed is independent of the fda process. Whovoids the fight over gives a vaccines first if it turns out to work. The process makes it so we understand if its safe and effective and if not it will turned out to be a wasted investment. It works out right it works are wrong, you lose. Finish this is my own two cents. Theres an enormous amount of Clinical Evidence to suggest the riskly and people at high of lethality from covid19. I believe these groups should be prioritized for vaccine. Maketion warp speed will the fight over who gets the vaccine will be less of a harm. Cal i think operation lightspeed will help make it a celebration rather than a political fight. Soon. The vaccine come thank you dr. And thank you to all the witnesses. Lets begin the q a. As a reminder, each member will have five minutes to do their all justng and theyve to make sure they all ask the questions in a timely manner. Several times seen the past people Start Talking before anyone near them and it looks like a silent movie. We will try to wait before starting the questioning. I would look to first recognize myself or questions. Rpac. Alked about vi mentioned, when jesse was created when president reagan took office. Please introduce us to it, what kinds of people sit on this committee and what is its reputation . Reputation is providing unbiased careful assessment of data and communicating that to the fda and the public. Wideally members have a range of expertise that leads from basic science, pediatrics, internal medicine, biostatistics. And these people come from academia and Public Health backgrounds. This also a consumer representative and an industry representative. It sounds like one of the biggest positive aspects is it thatublic deliberations so there is widescale understanding of whats going on. I completely agree. Its both at the public can understand, its a two process. The public can understand and make their points heard because it could be they have not yet heard whats really concerning the public. Would you agree it should be currently the process underway for determining a safe and effective covid19 vaccine . I would absolutely agree, yes. Concerned, iely want to turn to another topic, im concerned the fda may choose to prematurely grant an emergency use authorization to a vaccine for covid19 just like it did for hydroxychloroquine, a decision the fda later revoked. Weve heard about operation warp speed. Im concerned about those being handed out at warp speed. Certainly in the concept context of covid19 vaccines. Law, does the commissioner have the authority to issue that before the completion of the stage three Clinical Trial. The regulations around emergency use authorization require Public Health emergency declared the secretarial level and then in fda assessment should be independent that says. He likely benefits dr. Schwartz, do you think an emergency use authorization should be used for the completion of stage iii Clinical Trial . I would be concerned for the reasons mentioned in the Opening Statement that it would not be understood from the public to be different from the full approval and moving forward introducing that without the kind of evidence we want to have. I would be very concerned about that. Youd be concerned because you think it would be potentially dangerous. I think wed be moving forward with less evidence that would like to have. It would mean moving forward in all likelihood with less than we would expect from full approval. Including virpac before any kind of eua or approval was granted. Id like to see if it were to be considered, it should be part of those conversations as well. Based on what we saw with hydroxychloroquine, do you have any concerns about these here . The mantra shows the data and thats what its about. The phase three trial is a robust opportunity to look at a large segment of the population. Thats whats needed to make a responsible decision. There have been reports recently convalescent plasma from covid19 antibodies have the potential of conferring immunity. Dr. Fauci recently called it a very attractive concept. Do you think the federal government should be exploring before a vaccine arrives . Toi think this harkens back my yes and comment. It not only applies to the vaccines but applies to the multitude of these countermeasures. So whether plasma oriented bodies, i think both of these are promising and we should pursue all of these. Expired, let me recognize i think Ranking Member is still with us. Yes sir, can you hear me . I can hear you but i cant see you yet. Now for fiveou minutes of questioning. Thank you chairman, i appreciate it. Thank you all for being here, appreciate your time and your research and service and science and for being here today with us. As operation warp speed eliminated any steps in the vaccine approval process . Not to my knowledge. Its my understanding operation warp speed has enabled a speedier process by simultaneously running through the process of Clinical Trials to help us get to the vaccine. Thats my understanding. It basically allows the process for manufacturing to run parallel with the process from the trial first and then. Sure you could take 45 minutes on this, but can you compare and contrast were normal process is versus what the administrations approach is in this time . The normal process wouldnt involve federal spending into r d. The normal process would involve seen. Idance like weve a normal process wouldnt say things like we expect police 50 efficacy per thats a higher standard than would be expected. The fda has signaled very clearly they expect high bothards for this vaccine in terms of efficacy and safety. That in a sense goes beyond the normal process. Business wouldnt say im mr. Manufacturing a product before think it works heard operation warp speed makes that happen. Also the product itself. Work, its been wasted. If it does work, it speed up the ability to employ it at scale. Part of the reason for the lengthy process is for companies usually minimize financial risks. Administration prioritizing saving lives over strategic financial risk is the goal here, is that my understanding . Is the goal. , the public is for tremaine factors through the studies and work carefully in the wreck of the isy process to make sure it safe and effective. And if it is its ready to deploy. And if its not calmly made a gambling be lost. Gamble, we make the produce a vaccine that works. There has 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 competitions we are seeing . We have seen an extraordinary increase in the number of suicides. Lockdown has Mental Health effects. Delays and basic treatment. We seen delays in cancer , basic essential , i suspect over the long haul we will find a big increase in other Health Problems as a result of the lockdown. I know you worry real scientist not a political scientist. But theres been a lot of discussion about the political asian of getting a vaccine sooner than later. There a biblical benefit to saving lives sooner than later. You think theres also an incentive for some to delay a process . I would hope not. Maybe im naive. I would hope people come together and say lets look at the data and see if we have an effective vaccine lets get out as soon as possible. I have a lot of confidence in the fda to evaluate it fairly. Much. Nk you very hopefully all of us to agree that the data should drive the process. I yield back. Much. Nk you very now i would like to recognize chairwoman maloney for five and fivestion spring minutes for questioning. I want to thank all of our panelists. Operation warp speed has promised a safe and effective Coronavirus Vaccine will be doses would be available by january 2021. They are also eager to be the vaccine to be developed, i am troubled by reports that there may be some political pressure on the fda to cut corners. Im encouraged but i do want to ask what would come from cutting corners in the rush to bring a corona vaccine to market . Weve heard a lot about the process of Vaccine Developments the part of the lengthy process is to reduce the financial risk. And reading that should be done or can be done without minimizing itself. Process theith this comes from these is thoroughly investigated. Both in terms of the immune response and the effectiveness. And worry that in the rush we might miss something. We cant really afford that. Maintain ane expedited timetable while completing all the steps to assure a safe and effective vaccine . One of the comments made was the process we put in place 10 years ago, an independent group was looking at the data as it occurs, the safety data. It had an unfortunate name of vaccine Safety Risk Assessment working group, but its value is they were looking at the data coming in every month. It had a public process that everyone could see what they are looking at. Things like that would be really important, the public can see what the scientists are seeing and see if there are any signals. Rep. Maloney thank you, that is a good recommendation. It is imperative that safety comes first in Vaccine Development. Once a safe vaccine is developed, it must be employed in a way that ensures equitable distribution, accessibility in all parts of our contribute our country. I wrote to hhs to request contracts with the people developing Coronavirus Vaccines viewed the federal government is investing billions of taxpayer dollars. We requested the contracts to better understand that they include provisions to ensure affordability and prevent profiteering at the expense of the American People. Unfortunate, hhs has not completed our request, so we will continue to press for this. Dr. Schwartz, i would like to turn to you again. [indiscernible] ensure that everyone in the United States has free access to the Coronavirus Vaccines . Thank you, chairwoman maloney. Yes, i think its right even 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 assessment and coordination in government leadership to think about the issues around deployment. And we have, particularly the centers for Disease Control and prevention, a 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 at the scale we need. 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. Rep. Maloney you were saying the federal government is already planning and investing its resources now to ensure a vaccine is deployed successfully . Im not so sure about the level of investment but i do know expert advisors at the centers for Disease Control are already thinking about these questions around prioritization 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. At least on the conceptual level. It will be more than thinking and planning. It will be about resources needed to scale at the Vaccination Program if and when we have vaccine. There is a lot of work needed and a lot of steps required. Rep. Maloney finally, once a vaccine is deployed, we will need to continue practicing social distancing and taking off precautions such as masks as it is deployed, is that correct . Absolutely. The vaccine will be an invaluable supplement to the tools to use. It will not end 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. Rep. Maloney in closing, i think the chairman and 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 grothman. Are you with thought i saw you. Im back. I hear you, i cannot see you yet. Can you turn on your video . Rep. Grothman 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 rep. Grothman there i am. There you are. We got you. We see you. Rep. Grothman i am going to start off by questioning you are recognized for five minutes. Go ahead. Rep. Grothman you started off by saying we have to go with the experts. My concern is frequently experts vary. Right now in the United States, we spent, might spend the most for health care of any country in the world, certainly 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. A doctor talked about pills and procedures, we seem to have almost a blind faith in this country towards medications and more procedures. I think we have to remember that before we 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 a lot of things wrong. At least in this state, they told people to stay inside. I read experts saying go outside both for the fresh air and for the sunshine. I think they were overusing ventilators. I think they way overestimated the number of deaths, at least in my area. There were cleaning out the hospitals. You couldnt get what were considered to be elective procedures or that sort of thing, many of which were lifesaving. And and i think there are a lot of experts who would now say people died because we were not doing certain procedures in hospitals waiting for a delusion a deluge of patients that never happened. District,kly in my nurses were being laid off. I want you to remember throughout this that experts disagree. 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 emptied out hospitals and 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 . There are so many things they were not doing in hospitals 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, there was quite a bit of 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. As a result, the lockdowns, i believe happened earlier than they should have done. I think lockdowns are an important tool in some places where hospitals overrun. As you know, many parts of the country have seen bankruptcy in hospitals as a result of having 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 believe we should stop looking at experts. We should continue to look for good data. Debate among experts, not silencing experts that disagree. That is part of that. There should be acknowledgment that experts disagree. Rep. Grothman ok, just one other comment and then i will let you guys go. Somebody gave me a book, plague of corruption, by someone who is 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 who 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 it will be good to have summary on the panel like this who may be thinks we are overvaccinated 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 on the data, to see what decisions are being based on and having public debate about it is good. A lot of people who read a lot are sometimes jaded on the vaccines and a lot of people in the panel. Our concerns about vaccine safety and we want to be sure to thisng is done confidence theres been a process in place that ensures they are safe and effective. Even on this panel weve been quite clear our concerns everything be done to ensure those things. I have to jump in come we are going over here. The witness can finish the answer. What we are seeing now is extraordinary. Heard of the six or seven months ago and now have an unbelievable amount of science watching science in realtime can be confusing because every day you learn Something Else coming to forward, step back, a step sideways. We need to look at the science and look at it, i agree looking at it every day looks confusing. One study seems to say one thing and one says another. Thank you so much for that line of questioning. Let me turn it to congresswoman presley. You have five minutes. Thank mr. Chair for directing your collective focus to this critical issue. I think our esteemed pencil esteemed panel of experts and saying dr. In dr. Fauci i trust. Today im about it of a doctors solemn promise, do no harm. Our approach to Public Health must prioritize that simple principle. Do no harm. Unfortunately the current temporary occupant of the white house has spent his entire life cutting corners to get results at the expense of others and cannot allow that pattern and practice to coppermines the ethics the geithner community. Demonstrate more than any other time the need for deliberate process and value equity and inclusion. Latinx citizens are hospitalized more than four times the rate of white americans due to coronavirus. The same underrepresented in Clinical Trials. Critical thatly their work is informed by those who are hardest hit. Operation warp speed needs to make time for Health Equity before it is too late. United states hopes to successfully emerge from the pandemic every step of the process must be fair and equitable. During Clinical Trials, why is it important to include volunteers from Diverse Communities . Lot about the a size of the Clinical Trials which is important. The size of those trials allow you to look at population. If youre recommending a vaccine for people in this when we expect the recommendations will be for everyone. We want to make sure those work and are safe. , show sufficient numbers of each of those subsets may not have full confidence when they are used more broadly. Color,are communities of could you elucidate us, how are communitys of color typically engaged in the Vaccine Development process . Others can elaborate. Rowboat process involves people. People recruited as volunteers in the studies and i can be a challenge when volunteers do or do not want to enroll. Swathe look at the broad of the population the current just Clinical Trials include representation so we have information. Equity has to be centered in everything but there is also group fear based on history, if you look at henrietta lacks, what are we doing now to ensure we can put the data we need from historically underrepresented groups . I can speak to the work in particular that warp speed didnt warp speed is doing. They are engaging our 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. There two things that identified. Thingbvious and important is some of the study personnel also need to be part of this group. They need to be approached by people who look like them. And one that int hope i highlighted in my remarks is that many of these individuals have said will i be will i do a vaccine be able to get a vaccine in the end. Will it be freely available. Access. Ate acts but discusso want to elevate the fact women are also often underrepresented in these trials. I want to turn would turn what happens even if the vaccine completes phase three trial, there could be insufficient data how it affects average populations. Couldamericans, elderly, the fda still approve a vaccine that didnt have evidence of safety and efficacy for populations and what are the potential ramifications of doing so . Intent is of is the to prevent that in these trials. The fda would look at the data and lets say one group was underrepresented, that could be reflected for product labeling or recommendations for how its used. They require additional studies. Groups, not just , theities, but the elderly aft it can require studies. I do think to track data on their safety and effectiveness. In closing i want to thank i believe it should be widely accessible and free to all. The testinged to me and treatment would be freeforall. Ensure for act to the heartsick communities. Thank you. Recognize like to congresswoman miller. You have five minutes. Chairman and Ranking Member and all of the witnesses for being here today. The covid19 pandemic has highlighted within our Health Care System. The pandemic has also demonstrated what could be accomplished we develop public and private partnership. Commitment to finding treatments butot only tackle covid19 other diseases as well. Im encouraged with the administrations commitment to streamlining the process of a vaccine and treatment will alter the insuring safety is above all a priority. Operation warp speed has been a testament to scientific innovation. 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 . Theres Nothing Better than providing good data and information. Talking thee vaccine. I think in the future, the comes of this process. Making the data transparent and available you can see with the safety concerns are is critical. It seems we need to take some kind of additional steps to increase the awareness come we can help grow the confidence in the integrity that are being made right now. Can you speak to the challenges of developing a treatment or vaccine for coronavirus. You have to decide what parts antibodies, with all this happens for you touch any human. And then you have to make sure small populations very healthy people, establish appropriate dosing. All this happens in the phase one trial. Diseases any concerns coming after sample sizes that are theyous to make sure measure the effectiveness for sufficiently long. Of time with the chance of picking up. Under all of those normal circumstances, the extraordinary thing about the effort thats is what happened a few months time the normally take years. Its incumbent on us to convey to the American Public what these mean very clearly and loudly in terms that people can understand. If there is a safety signal, if its not as effective as we hoped. A very full confidence that they will say produced bye data those running the trial, its under an enormous amount of , guides the fda put out concerning what they expect to see that include a lot of concerns other Committee Members , simple size, diversity of population. I think were going to see we can learn a lot about whether these vaccines work. I hate to interrupt to but i want to make the point that 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. About what the alsobilities will be and feel there Many Companies that agree to donate doses to the federal government for distribution. I want to see what is needed to ensure those doses are distributed for all americans across the country. I think operation warp speed is a step in that direction. The vaccine works, if they synthesize a vaccine, every personal Health Insurance can get it. Thosehink to allow vaccines. Thank you, yield back. Id like to recognize congresswoman tlaib. Starrymultitasking, so im so sorry. Thank you for being on this call. One of the things i wanted to focus on and chairman for this is to talk about the effectiveness and safety. Step but i think i want to start with you on some of the basics. What will a successful vaccine do and how will that phase three trial ensure the vaccine does what he needs to do. I think in the guidance there outcomesal possible that could be attached. Thingk the most important for a vaccine to do is to prevent severe illness and death and i think fda guidance does speak to that and says at minimum must be a secondary outcome and could be considered a primary outcome. Other outcomes that can be looked at. Because they honestly think even the vaccine prevention but still allow disease to occur would not be a failure come we would count that as a success. What does the fda guidelines mean when they say the vaccine must be proven to be 50 more effective . That it must have 50 efficacy. Iswhat that would mean somebody who was vaccinated lessve 50 glass chance of having a particular outcome. I just made two comments about that because in some ways many of those vaccines are 90 effective or 80 effective. The American Public might think 50 is a low number. But a couple of things to say about that. One is that frequently what we see with vaccines is they are so he vaccine the 50 effective against a mild disease might be more effective against severe disease. The other thing to say is if we had a vaccine if we had half the deaths in the country weve had from covid, that would still be a major accomplishment. The subcommittee wrote a for commitment for 30,000 participants, we havent seen a response yet. Part of the trial designs the number of participants. Where the risk of having too many too few people in the Clinical Trial and one of the endorsed phase three trial of police 30,000 people, do you agree with them when need to hit that mark . I think they were outlined well in the guidance. For the reasons we talked about the question is should be 30,000 . I think its a pretty good number. That will allow us to look at population. When the data comes through we will need to go and look at that. You helps to ensure evaluation of each of the groups. I saw the work youve done on a vaccine safety. How important is it to include women in these safety studies . Important forally some of the reasons i mentioned. Gatheredis still being as to whether pregnant women have severe risk of the disease, there are some data that morests they may suffer than other subpopulations. At the very least they dont have they deserve an opportunity to be vaccinated. I yield the rest of my time, thank you very much. Thank you so much. Now we go to congressman connelly. Can you see me . We can see parts of io. Parts of you. Your recognizer five minutes. Thank you all for being here. I want to talk about efficacy and risk. How long does it take historically to develop an effective vaccine . Several year process. Whats the fastest vaccine ever developed . Probably the 2009 pandemic on enormoused influenza vaccine design. So for example hiv goes back to her 1980. Back to around 1980. Case that prevent the transmission of aids. Hiv has been a hard target because the bodys immune response to the virus. The spanish influenza, maybe thats more of a parallel. That was 100 years ago. 1917 in 1980 1918. Do we have a vaccine that prevents somebody from getting the flu . Vaccinese influenza and as you know they change every year based on what strains are circulating. We also develop them against pandemic threats. They merit there may be an analysis analogy to this Something Like ebola where the vaccine is available within a few years. But the point is most flu vaccines help with the severity of the flow, they dont necessarily prevent you from getting the flu. Fair enough . Both. Y do they reduce risk of an actual infection depending on the year. At they are more effective reducing complications. We are talking about efficacy as if its 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 you are better equipped to fight off infection. Absolutely. If we could reduce mortality or hospitalizations. In this conversation i think weve lost sight a little bit of what efficacy means. It isnt necessarily a cure. In the history of cure through vaccines is very limited. Risk, im old enough to remember if you rush aong drug to market. To horrible deformities in the babies that were born weigh risk here and hundreds of thousands are dying, millions of getting infected what risk is accessible and what risk isnt and how do we insulate ourselves politically from the pressure we are seeing from this president and administration to cut corners scientifically already . What confidence do we have weve taken into account risks . If 20 of the people who get vaccinated develop kidney disease, that seems to be a highrisk that would be acceptable. Covid19etheless cap that might be acceptable. Can you talk about this . They all point to the same thing. They point to the process of review and the independent science the fda brings from this and their decisions and deliberations is always about benefits and risk. Nothing is perfectly safe and nothing is perfectly effective. If that balance we have to look at here. That balance we have to look at here. I know i just of a few seconds. , so im shaking his head vigorously ended like to hear from him and then i yield back. Its these are difficult questions about thresholds and whats needed. This is why we need to defer the kind of structures for these tradeoffs then he vaccine. These might we have come down the line. Thank you so much. Now i recognize congresswoman katie porter for five minutes. Thank you. I am a mom with three kids, i want to make the best possible decision i can for their health and further community. Thats why every single year we all get a flu shot. We wash our hands, we wear a mask, we are doing the right thing. I believe that vaccines are safe and effective. Imagine that we are living in a world six months from now where the fda has approved a covid19 vaccine for use. I am a concerned parent and i have been hearing a lot that the president pressured the fda to approve this new covid19 vaccine. Do you think i might be nervous about getting this vaccine for my kids if i saw the process thought the process was rushed or different from other vaccines that i use and know are safe my kids . Safe for my [indiscernible] those same reasons. The information that comes from this study will help inform that. It also raises the issue of where you get your information and who are your trusted sources. Another layer is that while this data is important and many experts will review it, its critical that the people on the front lines, doctors and nurses who will deliver the vaccine are going to be asked questions by you and other patients and they feel confident in the process. They have to know this was undertaken in a way that would bring about the best results and to understand what that was. They need to be the translators of that information. No more trusted source than those who you trust you and your Childrens Health two. Another key is to make sure that the data that is provided here is translated and provided to the frontline workers so they can answer questions like years. I appreciate that, because most people will not be reading medical journals or combing through the fda website, they will be googling or on facebook. You are right to point out that doctors and nurses my childrens pediatrician has been their pediatrician since they were born, but i am worried i am not going to get this shot from their pediatrician. I am going to get it in a mass Public Health setting. I think its important that the fda puts out that information in an acceptable way including with providers you can reach out to by phone. What happens when people hear these stories about what happens when people dont think it is safe and they have not gotten the usual information they can get. What happens when 40 or 50 of the population doesnt get the vaccine because they dont trust it is safe . Unfortunately the stories you mentioned are out there. Even for vaccines that have been through Clinical Trials. Is tok the response inoculate against misinformation , which is not easy to do. On your question if not everyone gets a vaccine, there are models on what it will take to achieve heard immunity to stop the virus. Workssee that the vaccine 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 than they rethink a previous decision , which is why the information needs to be out there and we need to make sure the people on the front lines are able to respond to questions like years. That is helpful. I think we have seen in the last month when the public does not understand or is given any kind of mixed signals about the Science Behind Public Health and virus prevention. Even something as simple as a cloth mask has become an aggressive debate, social distancing has become more and more controversial. , wearing a is there mask and vaccines do work, but because we dont have a clear message from the federal government about the validity of social distancing and things like Wearing Masks they become divisive. We cannot risk the same thing happening with the vaccine because it is so imperative that every person who can get this vaccine once it is developed does so. Is there anything more the fda should be doing with regards to gaining that Public Confidence for vaccine adoption . [indiscernible] Public Confidence is an important part of it. There needs to be an effort to communicate things in a way people can understand. Often the language of the experts is not that approachable, so we need to translate that so people can understand what it means. We had a discussion everyone on the panel could give you the math behind it but that does not mean the people that hear it understand it. Thank you, i yield back. Thank you, congresswoman. Congressman, you have five minutes. Thank you, mr. Chairman. Can you hear me . Yes. I want to thank the panel. This has been a very enlightening hearing, i appreciate the testimony of how to balance speed with safety as we pursue these vaccines. Invite any panelist who wants to respond to this, if you could compare this Covid Vaccine pursued with what Many Americans are familiar with andh is the flu vaccine maybe compare it in terms of ways the Research Happens around , the way thate gets administered, the extent of uptake of the flu vaccine in the population, what is the confidence level around the flu vaccine and how do you compare that to what you are seeing in surveys about a potential arenavirus vaccine and what some of the practical dimensions distributingld be a Covid Vaccine at the same time that we would be distributing a seasonal flu vaccine. Since that is the frame a lot of americans have for a vaccine i wonder if you could draw some comparisons and analogies on those various i can address that. The flu vaccine has big uncertainties and it depends on what strain of the flu will be dominant. We have to make best guesses about that. It has to produce the antibody response once you identify what strain will be predominant. By contrast, in this case, we dont know how effective the antibody response from the Covid Vaccine is. In that sense, more uncertainty is around this vaccine then we have in the traditional flu vaccine. Time, the number of trials isthe extraordinary that at the fda is testing and we will have a lot of information about how it works. [indiscernible] i think it is more and less uncertain more uncertain because we dont know about the response. We know what the virus is but we dont know what strain of the virus, less uncertain because we dont know about the antibody response. [indiscernible] asked ank you have critically important question. In peoples minds these are similar. We accept this to be somewhat like influenza and this is an important conversation. The figure we have all seen about flattening the curve, that comes from work 15 years ago on influenza. Curve toten the keep people out of the Health Care System until the vaccine arrives. Because we have experience making the influenza vaccine we knew we could do it. Itsew we could get there, just matching the strain of the pandemic. We are flattening the curve to keep people out of the Health Care System until we have a vaccine that works. Another question we can get into is about distribution and the simultaneous use of vaccines, these are very important questions that we all need to be working on so there is not confusion about these two. Thank you for asking. I have 45 seconds, if somebody could speak to the 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 . To perceptionlate of whether it is risky or not, or the risk involved in not giving it compared to what you are hearing about their views of the Covid Vaccine . Half the population gets the flu vaccine not aboutence is safety, it is about how well it performs. If people dont get it it is out of that and not out of concern on the safety profile. Thank you, i yield back. Thank you so much. Appreciate everyone who participated in today possible hearing, especially to the panelist. Thanks for a grueling session of question and answers. I also want to conclude by saying that we all want a vaccine as soon as possible, i think that goes without saying. The creationpedite of a safe and effective vaccine, but the only way to do that, and i think there is unanimity on this point, 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. About the think economics and the prioritization and delivery of the vaccine, simultaneously the creation of the vaccine, but we must not cut corners and do anything that thed hurt or harm conclusion that whatever the fda ended up approving is safe and effective. Thise that coming out of hearing we proceed based on those two conclusions to make , thethe fda does its job commissioner answers our letter and assures us that he will continue to maintain independence of the fda and that we will have participants in the human trial, and that the group is engaged fully in the deliberation surrounding the covid19 vaccine. I would like to thank you all for participating and this session is adjourned. Thank you. Washington journal. Every day we are taking your calls live on the air on the news of the day and we discussed policy issues that impact you. Coming up, American Federation of teachers president discusses the union possible position in the debate over reopening School Position in the debate over reopening schools. We also talked about campaign 2020 and President Trumps reelection strategy. Watch washington journal live at 7 00 eastern this morning and join the discussion with your phone calls, facebook comments, text messages, and tweets. Join the discussion. The cspany on networks, the house continues work on the fiscal year 2021 defense grams and policies bill, at 9 00 a. M. Eastern on cspan. T 9 30 a. M. On cspan two Maryland Governor larry hogan and dr. Scott gottlieb discussed the maryland coronavirus pandemic response. The Senate Returns at 10 00 a. M. For their work on the defense programs and policy bill. At 10 00 a. M. On cspan three the house subcommittee looks into the covid19 vaccine with witnesses including a former cdc director and representatives from several pharmaceutical companies. On1 40 five joe biden speaks the coronavirus pandemic and economic recovery from new castle, delaware. Senatee center,s commerce subcommittee investigates covid19 scams. Watch our live daily unfiltered coverage of congress, the white house. Our countries are linked by trade and travel. Ongoing efforts to focus on andmission to save lives meet the needs of our states and health care workers. On theg with briefings coronavirus pandemic, Supreme Court oral arguments and decisions. Campaignatest from 2020. The a part of the conversation every day with our live callin program, washington journal. Coveragessed any live watch any time on cspan. Org or listen on the go with the cspan radio app. House began work on legislation that authorizes nearly 700 or 2 billion for defense programs and policies. Or than 400 amendments are being considered with a final vote on tuesday. We will show you some of the debate now. Myselfspeaker i yield such time as i may consume. The gentleman is recognized. Have before us the National Defense authorization act for fiscal year 2021. Its an important piece of legislation we have done every year for 59 years. It is incredibly important that the United States congress, house, and senate exercise our the department of defense and our National Security Budget Priorities in this bill reflect that. I want to thank a lot of people who have done in the normas amount of work to make this possible
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