Transcripts For CSPAN2 Hearing On Vaccine Research Development With Pharmaceutical Companies 20240712

I is possible. They also appreciate the chance to bring some ten i ten unseat e Trump Administrations work speed effort. This transparency will be crucial to secure the american Peoples Trust that the vaccine will be made available only once it is proven to be safe and effective. Congress has already taken actions to support these efforts. This spring, congress provided the Vaccine Development and manufacturing of birds and other medical countermeasures. Then two months ago the house passed the heroes act, the comprehensive legislation to strengthen the nations ability to fight the pandemic like altering the Strategic National stockpile and increase funding for Research Development and manufacturing vaccines and treatments. It would also require the administration to get to congress a vaccine plan identifying the activities undertaken to manufacture distributed vaccines safely. The house passed the act more than two months ago and the senate has failed to take it on into the death rates soar. Its compounded by the fact moore could have been done to mitigate a disease. From a number one President Trump has done everything he can to minimize the severity of the pandemic and to undermine his publichealth experts. The Administration Still hasnt developed a National Plan to combat the pandemic. It has no National Test no one in charge of the supply chain and little effort to invoke the defense production act. We are against seeking the resurgence of the same problems that hampered the response efforts this spring such as testing shortages, ppe and medical supply shortages and a tax on publichealth experts. These will likely center for Development Distribution of this before vaccine as long as Congress President and we all want a vaccine to be developed as soon as possible, but before a vaccine is distributed, publichealth experts must ensure the Safe Committee that he band available tevent availad it. My fear. We must ensure the supply chains can safely manufacture the vaccine in the quantities necessary along with other products required to administer. The committee has a long history of supporting efforts related to the developed and playmate and im hopeful if we prioritized the strategic preparations and the administration finally learns from its mistakes that the collective efforts will result in a safe, effective and accessible vaccine coming and i would now like to deal with the remainder of my time to the chairwoman of the house subcommittee, ms. Anna eshoo of california. Hispanic thank you for yielding and good morning to my colleagues and to the witnesses. Each of you represents great hope for americans and people around the world. Speaking of hope, we cant help but think of our colleague john lewis who always said keep your eye on the prize and i think that is what we are talking about this morning because all eyes are on your companies to develop a vaccine that will allow us to return to school, to work out to hug our loved ones and begin a process of recovering from the pandemic. With that opportunity comes great responsibility to ensure products are safe, effective, affordable and accessible so i look forward to hearing from each of you today how you are going to make a transparency and accountability from the american taxpayers and the american patient, how you are scaling up domestic manufacturing thank you again to each of you for testifying. The chair of the subcommittee for holding the hearing and i look forward to not only hearing from you but working with you and i yield back. The chair now recognizes the Ranking Member of the subcommittee for five minutes. Thank you madam chair. Appreciate you holding this critical and important hearing. First i know i dont have to make a unanimous consent request that for the record, ms. Rogers and mr. Carter will be sitting in on the subcommittee. Thank you for holding this important hearing. This before pandemic has been a tough challenge for the incredible effort to develop safe, effective and accessible covid19 vaccines gives me great hope that we are on a promising path to solutions. The unified effort by vaccine manufacturers in the Research Community and federal partners to work with each other is remarkable, and im confident through this unity of purpose, cooperation from a focus on expertise and a tremendous amount of resources. And the accelerating therapeutic interventions for the manufacture and distribution vaccines therapeutics and diagnostics. The testimony today for the witnesses of the vaccine candidates will be a vital interest to the American People. The companies represent the first portfolio platforms with promising primary data for example the experimental vaccine reportedly provided authority by the volunteers with immune responses to the rear generally well tolerated. The university of oxford candidate might complete the trials by september and agreements have been mined to produce 2 million doses by 2021. In addition, there reportedly is positive news on the Response Team from the antibodies in the cells. Last month, some vaccine experts expressed concerns that the Trump Administration and then when it gets assurance that the vaccine will not authorize unless theres 30,000 people in each phase three Clinical Study. It appears such assurances have been made by the Trump Administration. The leading vaccine candidates under the auspices are required to enroll 30,000 participants in the trials. As doctor fauci of the Infectious Diseases at nih and doctor stephen hoge testified before the full committee on june 23, there will be no shortcuts on safety and efficacy standards. The speed is being achieved through the financial risk. I will repeat that, of manufacturers, not safety or efficacy. And accelerating the capacity to this millions of doses and not at the expense of the safety and efficacy. Concerns have also been raised about vaccine content and whether there will be sufficient Vaccination Coverage to ensure her community. We need to have a High Percentage of American People vaccinated to achieve the protective effect of herd immunity to save american lives. Regarding supply, the manufacturing capacity we will hear testimony of how these companies are working cooperatively to address potential supply concerns. These companies in the aggregate are committing to manufacture billions of doses. I look forward to hearing more about how each of the companies before us today plan to scale up manufacturing efforts to ensure an adequate supply of an authorized or approved covid19 vaccine. Finally, access and affordability many manufacturers have told the Committee Staff that if the vaccine effort is successful, they dont want cost to be a barrier to accessing a covid19 vaccine. This is a welcome commitment and we are eager to discuss it further. The mission to get safe and effective vaccines have been a driving force for the committee republicans. At the beginning of this month, leader walden and i released the second wave product with recommendations on how to better prepare the production and distribution of the vaccines and therapeutics. I welcome all of the witnesses and look forward to your testimony and discussion of these issues. Madam chair, i yield back. Todays hearing will examine efforts to develop safe and effective covid19 vaccines. And i know i speak for everybody this morning and saying we are all rooting for a safe vaccine to be developed, manufactured and accessible for all americans as soon as possible. This committee and congress have launched the federal effort to advance the development and availability of the vaccine. This spring we provided billions of dollars in funding to support vaccine Research Development and manufacturing. Further assisting some of the companies testifying today in developing covid19 vaccines. This committee has the responsibility and oversight today we will have the opportunity to hear from some of the manufacturers working on potential covid19 vaccines and how the Funds Congress provided are being put to use in these unprecedented times. I think the witnesses for being able to participate in such a critical hearing and critical time. We are now six months into this National Public Health Crisis and covid19 case numbers continue to climb at a staggering rate. Today more than 140,000 americans have lost their lives to this disease. As long as the Trump Administration continues to short the responsibility to lead a coordinated National Response effort, sicknesses and deaths are going up. Its also clear that we are not going to be able to contain covid19 in the United States without a rapid and robust deployment of Public Health measures and medical countermeasures, including a safe and effective vaccine. We note containing the virus as soon as possible is of utmost importance. Billions of americans face continued unemployment and loss of health insurance. Across the country, parents are making impossibly hard decisions about child care and school participation. Frontline Health Workers Comedy Central employees, people of color, seniors and others most vulnerable to covid19 face daily threats to their survival. Fortunately, there are reasons to be optimistic that the search for a covid19 vaccine is headed in the right direction. According to statements from several of the companies testifying today, and based on the speed at which they are progressing through Clinical Trials, it is possible a covid19 vaccine may become available by the end of this year or early next year. That is a bit of good news in this terrifying time. But while some Public Health experts are [inaudible] we must remind ourselves plenty can still go wrong so the anticipated timeline is not guaranteed. Determining the vaccines safety and advocacy is the first of many challenges that must be addressed to manufacture and distribute a vaccine to the americans and people around the globe. While we await the results of Clinical Trials, the necessary manufacturing and distribution infrastructure must be placed or so that its readily available for hundreds of americans once it is determined to be safe and effective. Additionally, as the pursuit of the covid19 vaccine moves forward, we must be prepared not only to produce the vaccine itself, but to have it supplies required to administer the vaccine such as vials and syringes. The Committee Heard from governors across the country just how unprepared we were as a nation to provide basic testing supplies like slobs and personal protective equipment. The lack of this undermines the response effort and we are still feeling the effects today. I have a concern with all of the efforts around the world to develop a vaccine, the government and manufacturers like with testing supplies and pp e. , maybe ill competing for a limited supply of items such as glass vials and syringes. These are critical and ultimately to deliver a vaccine showed one proved to be successful. Further, critical decisions must be made now across the federal Government Cut the industry and Public Health shareholders regarding vaccine rollout efforts and public and provider education. This is especially true given the value of any future covid19 vaccine life and the willingness of the American People to get vaccinated and their ability to access and afford it. Developing and distributing the vaccine requires a National Plan, one o that the administration stated is still being developed despite urging the administration to adopt such a plan two months ago but time is of the essence and now is the time to prepare for a nationwide Vaccine Program. Developed connie vaccine will be instrumental in protecting the health and wellbeing of the nation. While we are racing for all of your collective success, we must make sure its safe, effective coming and ultimately a portable for all americans who need it. The committee will continue to conduct oversight. These remain the focus of the pursuit for the covid19 vaccine. And with that, im pleased to yield five minutes to the Ranking Member of the committee, mr. Walden. I also want to welcome todays witnesses. We know that you ar that your ho develop the medical countermeasures including the vaccines that they are here to discuss today. We are literally working to save the world. We greatly appreciate you taking the time to participate in todays hearing. Energy and Commerce Committee republicans continue to closely examine Current Issues related to covid19 and how to prepare for an uptick in cases at the same time this season hits this fall. The. [inaudible] the second pillar of focusing on vaccines and therapeutics is includes a series of important recommendations that better position the country to produce vaccines and therapeutics. There are extensive efforts led by the federal government and private sector to develop countermeasures for covid19 including operation warp speed. Operation warp speed is an unprecedented pace to develop and manufacture and distribute covid19 vaccines. One of the many goals is to have as much as 300 million doses of the vaccine for covid19 available to americans by january of 2021. We have been able to identify vaccines and move to Clinical Trials. To put it simply theyve been an integral part and collaboration weve seen over the past few months in the federal government, Trump Administration, private sector is extraordinary and i commend all of those involved. At the june 23 hearing, we are taking financial risks, no risk to the integrity of the financial to be ahead of the game is safe and effective vaccine to be available to the American Public. In addition to the hearing today on an update on the efforts to develop vaccine, we also want to give that unprecedented speed doesnt mean sacrificing safety or efficacy. Along those lines, and also need to know how the companies are helping to build vaccine confidence. This is a critically important topic that spans the covid19 and beyond. Its made more urgent when its proven safe and effective in authorized by the fda. We want americans to feel confident in getting the vaccine. Its also vital when thinking about the fast approaching fall into the influenza season. We need a vaccine that is available but also is accessib accessible. Communities frequently are on the outside looking in but for covid19, no american should be left behind. Continue to work to provide a safe fixing my also the debate could ask you take into consideration a Robust Manufacturing process providing the vaccine in a timely manner to all americans. We also want to hear about the efforts underway to ensure there are sufficient amounts this is another issue we need to be taking [inaudible] if theres anything you need help on from the congress, we want to hear from you. [inaudible] without objection, so ordered. We have several members of the full committee that we will be waiting on a per the hearing today. For the majority congresswoman eshoo, and then we heard from the Minority Congress Mcmorris Rogers and congressman carter. I want to introduce the witnesses for todays hearing, doctor mene pangalos is the executive Vice President of the biopharmaceutical. The head of the Clinical Development and johnson and johnson, doctor Julie Gerberding executive Vice President and chief patient officer of merc, stephen hoge and the chief advisor for pfizer. Thank you for hearing today. Its important to you what you have to say. The committee is holding an investigative hearing and we were things of the practice of taking testimony under a. Does anyone have any objection to testifying under oath . The witnesses have responded no. The chair advises you under the rules of the house and of the committee you are entitled to seek counsel. Does anyone desire to seek counsel during your testimony today . Let the record reflects the witnesses havreflect thewitness. Good news, im not going to make you buy but raise your hand so you may be sworn in. Do you swear the testimony that you are about to give is the truth, the whole truth and nothing but the truth. You are now under oath and subject to the penalties set forth in 18 section 1001 of the u. S. Post. The chair will now recognize the witnesses for five minutes summaries of their written statements. There is a timer on your screen that will count down the time and it turns red when your time comes to an end. First im going to recognize doctor mene pangalos. Thank you very much Ranking Member guthrie and members of the subcommittee. For the discovery in the latest issue development of the pharmaceutical therapeutic areas. To develop the manufactured vaccines into the pure x. I hope to emphasize our dedication to finding safe and Effective Solutions for the pandemic in the United States and across the world. The 3 at will access other governments and organizations at first like to provide your a finance company with north american headquarters. Overall 13,000 employees in the u. S. Astrazeneca operates in over a hundred countries and the footprint and resources to address the crisis. Today i will focus on three aspects. For the covid19 vaccine candidate they are calling the 22. That could result in the unnecessary stand up for 300 to be Available Upon approval or emergency use. For the end of double Global Access we support the mission of the u. S. Fda to ensure based on sound science and data to continue to remain the top priority in this effort could vaccine candidate for the Clinical Trial based on the data into the clinical studies in phase one of the Clinical Trial in over a thousand volunteers to the. Theres 50,000 volunteers available by this faux. Second, the combination are in collaboration with Vanderbilt University is a supported by the development and trials in the next few the. Third, investigating the medicine to see how they could benefit covid19 particularly those patients that were example and to assess whether we could engage the exaggerated and new responses associated with the infection. In addition to the efforts we donated 3 million across the United States. It is emerging for the company. We comthey come to work every dy focusing on the goal of a. Members of the subcommittee, on behalf of astrazeneca thank you for the opportunity to participate. We appreciate your interest in these important issues, and i look forward to answering your questions. Thank you so much, doctor. Thank you for the opportunity to discuss johnson and johnsons efforts to develop a vaccine for the virus that causes covid19. Thank you also to the chairman pallone, walden and other members are joining in on this important discussion. I oversee the Clinical Development of johnson and johnson boxing portfolio including the covid19 program. I would like to outline our efforts to develop a safe and effective vaccine and with the public commitment to provide more than 1 million doses in the not for profit price of the pandemic use. Working closely with other agencies and academic partners, Johnson Johnson i and johnsong an accelerated approach to the development of the vaccine including largescale manufacture things which we start in parallel with Clinical Development and the availability and substantial quantities of the vaccines is found to be safe and effective. We formed an Important Partnership with the research and Development Authority our efforts progress rapidly since they began in january. In march, we announced the selection of the vaccine candidate 26 code to s. Next copy completed a pre Clinical Study and have submitted the results to the peerreviewed science. We look forward to the publication of those results in the near future. We expect to start a phase one trial later this month. This trial conducted in the United States and belgium was more than 1,000 healthy adults if those results are positive we will plan to initiate a phase three trial that month. We are using our technology to develop the vaccine. This is the same technology we use to develop for hiv and seek zika. More than 75,000 individuals in a wide range of populations including adults, seniors, infants, children and pregnant women. With respect to covid, we believe we can accelerate and ensure safety as we have successfully done with the ebola vaccine. As you may know earlier this year, johnson and johnson committed to bringing a vaccine to the public on a notforprofit basis for emergency pandemic use. The notforprofit price will be based on the structure and validated. Johnson and johnson committed to include first patients in the study. They are in the process of developing the phase three trial and ensuring that it is a key consideration. For example, we plan to implement digital and Community Outreach to encourage the participation in the clinicals. Finally, my written testimony has Additional Information regarding the extensive efforts to increase the production custody. At the same time that were developing vaccine, so we can produce more than 1 billion in 2021 of which will be manufactured in the u. S. Madam chair, we recognize that this is a critical moment for the society. Johnson and johnson is devoting the energy and resource is to develop the save and effective vaccine for covid19 as quickly as possible. Thank you for the opportunity to speak with you today, and id be happy to answer questions. Thank you so much. Doctor gerberding, you are recognized for your opening statement. You need to un mute. Okay. Thank you. Thank you, chairwoman, Ranking Member guthrie and all the other members of the committee. I am honored to testify today. Thank you for holding this important hearing. I think my colleagues are risking their own lives while providing care to people. They are the true heroes of this pandemic. In 2003 i was serving as the cdc director when the virus thankfully lost the first race involving a new coronavirus. Due in large part to their heroic effort in hospitals around the world. But unfortunately, sarscov2 is proving to be a s. Its caused the loss of more than 140,000 american as the virus is far from contained. So the race is on. Not against each other but against the virus. Fortunately, the pandemic is ahead of us but in the biopharmaceutical industry, we are closing in faster than we ever imagined possible. According to the bayou trekker in the First Six Months from the time we learned about the virus more than 660 unique compounds are in various stages of developmenthedevelopment includ3 vaccine candidates, 196 antivirals and a 292 other treatments. But i have to compare that to aids when it took more than six years to get the first hiv drug approved 15 years before we have highly active therapy. This is the result of a robust pharmaceutical industry and all the partners throughout academia and the world of investigation. I believe this wont be the last or the worst we will face so we have to preserve an innovative and economically Sustainable Business as the frontline of the health protection. Failure to do so will jeopardize todays patients and degrade the future of the securities. Science is on our side as we approach the challenges that these are still the early days and theres much to be learned about how to safely combat it. Merck is one of the few companies that continue to invest in vaccines for almost 130 years. Given that long experience and expertise, we knew when we saw this pandemic emerge we had a special responsibility to help end it. We looked at many possible vaccine candidates into three main attributes. The can debate based on the proven platform for safe and effective immunity against other viruses. Second, we were hoping to find a candidate likely to be effective as a single dose and third, we want a candidate feasible to scaling and distribute on a global basis. We have one in Partnership Based on the same platform we use for the single dose vaccines that have helped contain the recent Virus Outbreak and also one that we acquire based on the which is used to immunize millions of children. As everyone has emphasized, it is important that we will not compromise scientific efficacy quality and above all safety assessments as we value the despite the urgency we all truly feel. There will be no safety shortcuts at merck. Finding the vaccine is only the first hurdles. The second is even greater. No one is safe until everyone is safe. Never in the history have we been topped with finding an affordable vaccine for everyone. The two fully immunize against vaccine preventable childhood diseases despite decades of effort or despite the long awareness of the threat of the influenza pandemic and supply is far less than 2 billion doses and most people in Resource Limited areas have no access at all. Merck does have a long track record of making Vaccines Available and affordable to people around the world and we are committed to ensuring affordable Global Access to any medicine or vaccine we help create. Our goal was to ensure we can make these available to whoever needs them and we will prioritize that based on risk and medical need. At the end of the day, it also requires trust and vaccine safety and the integrity of the vaccinate her, trust and medical experts and especially in times of crisis, trusting the government. That is a tall order in most countries including our own and we have to prepare now to support peoples confidence. Merck but this is a Daunting Mission and purpose that motivates us to commit our lives to our profession. Thank you. Thank you so much, doctor. You are recognized, doctor stephen hoge, for five minutes. Thank you, members of the subcommittee and full committee. Thank you for the opportunity to appear before you today. My name is stephen hoge and i serve as the president. I served as a resident physician at the hospital. A wife is also a doctor and there are several members of my family and im proud to work for a company focused on developing to stop this devastating pandemic. Its harmed millions of people millions of americans were out of work and have been touched by this in some way. Also in the working class we must do everything we can to stop this pandemic. We improve patient slides based on a kind of molecule that plays a central role in biology in human health and disease. With headquarters in the facilities in massachusetts. Since the founding in 2010, we invested in the platform and this creates sequences that recognize if they were produced unlike Traditional Medicine our approach sends a specific protein. Because it is flexible when he stepped forward to pursue the development we leveraged technologies and years of research that we have done before any of us have heard of covid19. Had heard of this before. We collaborated with the Vaccine Research center at the National Institute of allergy and Infectious Diseases. Took some great vaccine candidate. These efforts started with a virus and we use the information to develop a sequence that struck the cells. The immune system learns to attack and generate a protective immune response. There is a genetic sequence in just 63 days. A test with ten years of investment in hardware, platform. In march, the phase one study of the vaccine, which was led by the nih, the study of positive results and the findings were published by the nih and others in the new england journal of medicine. Earlier this month, over 600 subjects in the phase two study but now just over six months is about to become one of the first to enter the phase three trial. For the manufacture and distribution chains which should allow us to reach an annual capacity of 500 million doses. Throughout this process, we are focused on developing a vaccine that is safe and effective as possible. We are grateful for the hundreds of scientists and other employees whose hard work and sacrifice has made our progress possible. We are pledged to be joined by dedicated to Public Health officials and scientists and a host of agencies. I would also like to thank the subcommittee as well as the diligent staff we are grateful for the actions you and your colleagues have taken to support the funding efforts to combat this pandemic and we remain committed to collaborate as the process continues. Thank you and i look forward to answering your questions. Than thank you so much. Now i am pleased to yield to mr. John for five minutes. Chairwoman, Ranking Member guthrie and members of the subcommittee thank you for inviting me to testify today. Like my colleagues, i am honored to be a part of the panel. My name is john young and ive been in my work for over 30 years. At pfizer we bring change to patient slides and is more urgent than ever. We know that these vaccines are critical and good reach and scale to serve the billions of people around the world impacted by the devastating illness. On the safety and effectiveness there are clinical studies we have a process and application as early as october this year. This pandemic wasnt business as usual. The plan to help address the pandemic first sharing that will send insights into second at playing the Development Expertise offering manufacturing abilities to support others and last the rapid response. For the research and development in the scaling of the manufacturing capacity at risk at least 1 billion in 2020. To date weve not accepted the funding in the program and we recognize we are positioned within the expertise and Financial Resources that have the potential to develop a vaccine. If Clinical Trials progressed well and we see Regulatory Approval we hope to be able to manufacture up to 100 million doses by the end of 2020 and potentially more than 1. 3 billion doses in 2021 globally. Subject to final dose selection for the study. The partnership both companies recognize that technology has the potential. The rest is critical given that covid19 impacts communities of color in the u. S. To ensure the Clinical Trials are a key priority. We enact two of the four investigation candidates have received from the fda. Weve already shared encouraging data suggesting it appears welltolerated. Yesterday we released additional Clinical Trials which further demonstrates encouraging responses. An ongoing Clinical Trial will enable the selection of the candidates and identification of the optimal dose level for the safety and efficacy study of up to 30 [inaudible] they plan to begin to study latethe studylater this month se fda approval. We are working closely to accelerate while maintaining in the development process. In the parallel rather than sequentially but the only way while maintaining safety as a key priority. In the event that its successful weve developed work to scale up production for the Global Supply. In massachusetts and michigan in the supplychain. And finally, the goal remains for as many people as possible, globally and as quickly as we can. I am very confident science will win. Thank you. Thank you so much and its now time for the question and the chair will recognize herself for five minutes. Everybody knows time is of the essence in the search for a covid19 vaccine and obviously everybody wants it as quickly as possible but we need to make sure that its going to be safe and effective against the virus. I want to ask each of you your quick and honest assessment on the likelihood of a successful candidate and when they will be available to millions of americans. I only have a brief amount of time, so brevity is the answer of today. You stated astrazeneca has to have the results of the studies involved and its scaling up the hundreds of millions of doses of the vaccine to be immediately Available Upon the use authorization on approval. Briefly what do you think the probability of the vaccine and to do you believe that it will be available in the United States at the end of the year . Thank you, chairwoman. I think it is a great question and difficult question to answer. We are very encouraged by the data that we have. At the moment we dont know what the detection are for protection against the virus. But do you hope that it will be available by the end of the year . Doctor stephen hoge, moderna is set to begin its phase three study. Do you believe they will be successful and available for distribution by the end of the year . Thank you very much for the question. As well as on the idea that we have seen in the challenge models, so we are quite encouraged. Its a little bit beyond the case driven study but presuming that we are able to do it relatively quickly and not study we would know by about four and a year pfizer is developing for vaccine candidates and also beginning a study later this month. Then it expects to manufacture up to 100 million doses by the end of the year. Again, briefly, what is the likelihood that one of your candidates will be successful, and when would it be available to the American Public . We are very encouraged by the safety and effectiveness. We aim to complete and is subject to the approval. Its going to be pivotal to the safety and effectiveness profile. In the statement gets to be able to deliver 100 million doses and products in 2020 is a lot more work still to do. How realistic is your timeline based on the Clinical Trials and manufacturing capacity . Thank you for the question. We are very much encouraged whether or not we will be lucky in the right places to be able to get an answer on the efficacy it is possible that we expect results for 2021 as well as 100 million doses by the end of march. Doctor gerberding come as we learn from your testimony, the timeline is more than the others we have heard from us please tell us briefly reasons to be optimistic allamericans but neither vaccines will have access by early 2021 maybe even in january. I certainly hope my colleagues are successful in prosecuting their pipelines. We would not expect to have a licensed product until 2021 at the earliest. Thanks to all our witnesses. The chair will recognize the Ranking Member. I want to be able to make sure theres time to answer. The safety and effectiveness, they said they are not risking safety to science. It is important the American People here from each of you on their trials. Can you explain the unprecedented speed, what specifically, the safety and efficacy of your vaccine. The fastest vaccine to be developed was mumps and this took four years. I will manage the time to you each have 45 seconds. Thank you for the important question. I believe we can do this. Unprecedented times around the world, 24 7 work without having to demonstrate effective vaccine with lowering their standards and by the end of the studies, 50,000 people, a significant number comparable to the vaccines that have been approved in recent times. Thank you, Macaya Douoguih. It is possible to deliver a safe and effective vaccine, the ybor law vaccine. A lot needs to be done in parallel but it will be done safety and without compromising the standards we undertake for a Clinical Trial. The postmarketing surveillance and working on a plan to monitor safety not only correlating licensure but the duration that is deemed appropriate by the regulators so we will monitor safety longterm but should be feasible to do this. Merck has a long experience, theres a lot we dont know about this virus and special safety concerns including enhancement of the respiratory disease on the immunologic pressure. We are fully prepared to move as quickly as we can to the things we can do in parallel, the safety assessment, we are quite relieved the fda insisted on the same high standards of safety and efficacy with emergency conditions, with the vaccines we prosecuted in the past. Stephen hoge. We echo my colleagues earlier comments. We believe it will be possible to bring forward and effective vaccine. We have been working aroundtheclock as an industry and the company with outside our company as well to make sure we are doing incredibly responsible all the way through. The phase 3 program, following fda guidance to conduct a 30,000 Person Program in the course of the fall. We hope that generates a robust body of data demonstrate safety of the vaccine that can give confidence in this. Doctor young. What you heard from my colleagues in the panel ensuring the safety and effectiveness of any covid19 vaccine. How we were able to move quickly, we were in a fortunate position to leverage a couple years worth of basic science for seasonal flus and apply those learnings to vaccine platforms for covid19. My colleagues mention the American Public should take great confidence in fda guidance which transparently lays out standards for effectiveness and safety. And all those companies to demonstrate in a Clinical Trial for any vaccine to be approved. The marketplace does not do this regardless of timing. That is comforting to hear. I yield back. I will recognize myself for five minutes, let me say i have heard what some of the previous speakers said. Historically i am confident in the fda, now that trump is president i think there is a real possibility that he will pressure the fda to lower the standards by putting out new guidelines the vaccine has to be 50 effective but let me give you a scenario where the fda changed its guidance and says it has to be 20 effective or 10 effective, or keep to the guidance, yours is only 10 or 20 effective, and they approve it anyway saying it meets the standard even though you dont. I guess i am trying to rely on you as the manufacturers to assume he will not meet high standards either by changing the standards or by saying it is okay when you know it isnt. What can you do in those circumstances . I want to make sure you will guard against any pressure that comes from the fda to lower its standards or approve something that doesnt meet the standards. What would you do as manufacturers to help us out in that regard on the assumption we cant trust the fda the way you sort of assumed. I guess we could start with mene pangalos. That is difficult to answer but i want you to assume whats unfortunately shouldnt happen, you know the fda approving the drug even though it is only 20 effective. Do you feel an obligation to give us that information . Start with mene pangalos. Thank you for the important question. Interactions with regulators have given us now evidence of lowering the standards of thinking, as a company we always think about safety and efficacy first and foremost, making sure we have an effective medicine. We would not launch a medicine that is not effective. What i would ask is regardless what the fda says or does, we could have some assurance from you that you would tell us the truth about the effectiveness of the vaccine. Absolutely. Pivotal studies are published in pivotal trials so remember the vaccine will be used globally so every regulatory a he will have of you on the regulatory efficacy. Let me ask Macaya Douoguih the same thing. Assume you find out the fda will approve something you know is not 50 effect, give us some assurance you would tell us the truth about the effectiveness regardless of fda approval. Thank you for the question. We have a target target profile outside the minimum characteristics for the development of our product including assumptions on minimum vaccine efficacy. If we saw 10 , we would design our trial to outline the efficacy in a product profile the study would fail if it hit 10 . We make those results available bringing forward a product that was not found to be efficacious according to our protocol. Can you describe how you would report any adverse events that might arise in your Clinical Trial once it is available for use . Thank you for the question. Just like weve done recently in the new england journal publication any adverse events we would publish in that data, regardless whether the trial was successful or not. They set up an independent safety and monitoring board adjudicating and reviewing safety and efficacy of our studies. I appreciate your responses and i will now yield, to the Ranking Member for five minutes. If he is not there may be he went to vote. He did go vote. He was voting. We have another mister griffith, can we go to you . We have heard a lot, Ranking Members questions, you felt the air guidelines were sufficient, those guidelines issued in june of this year related to the covid19 vaccine. Lets eliminate any hypotheticals. The guidance issued by the fda sufficient to assure a safe and effective vaccine and if not say why. Start with you, doctor young. The fda should be commended, evidencebased guidelines in high splendor for safety and vaccine. The Clinical Trial protocols putting together for phase 3 study will follow those guidelines and where he vaccine to demonstrate lower effectiveness and the study. We have great confidence with the American Public and congress should be confident any vaccine that is approved should meet standards for safety and effectiveness. Anybody else want to weigh in on that . I want to clear up any confusion. Let me ask this question. What is fda requiring to ensure corners are not cut during the development process, the process is happening too quickly, we will start with whoever wishes to start. Julie gerberding. The way to think about this is to understand the fda is not loosening any standards, whatever portfolios or dossiers we bring meet rigorous standards. When we were prosecuting the people of vaccine portfolio it took five years from the time we did the phase 3 study until they approved the vaccine at the end of 2019. In the context of this outbreak. You are fully prepared to be transparent about safety signals and fully transparent about the efficacies we observed. Mene pangalos. From the guidelines of the fda, from normal standards, if we are able to meet them we will have a safe medication vaccine, nothing gives me the standards in any way. Appreciate that. Anyone wants to answer that question . We also agree the standards are appropriate, there are products, ensure we are developing appropriate studies with appropriate followup to evaluate the safety and efficacy of this vaccine. We also agree the fda had a Gold Standard and appreciate them being put out there. I did speak with doctor young earlier about this question. Has the Company Learned anything so far about working on the covid19 vaccine that might develop future flu vaccines and make that process more efficient and effective and frankly the vaccine created more quickly when we know what is ahead. Thank you for that question. I mentioned in my earlier comments, to leverage the basic research weve done with our partners, once itself to lower and more potent doses but also to change the codeing in order to develop it much more quickly than would normally be the case. A vaccine with an antigen for a particular pathogen or infection. The Technology Platform lends itself extremely well having more effective flu vaccines in the future and we apply learnings from covid19 programs going forward. Can you tell folks who are watching this on cspan what that is . The codeing our bodies normally use a code that our cells use to produce proteins in our body and we can use the same basic technology to enable development of immune response to pathogens like covid19. I yield back. Next is miss schakowsky recognized for five minutes. Thank you, madam chairman. I want to talk about price. Recent gallup poll says 9 in 10 americans are concerned that drugmakers take advantage of the pandemic to raise prices from insulin to countless other examples we have seen Drug Companies use monopoly controls and make it impossible for them to get their medications. Ensuring the safety and efficacy of covid19 vaccines, is critical, but it will mean nothing if the price is a barrier to allamericans. To the witnesses, your trade association claimed in an advertisement, quote, we have had a number of companies that have already made public a public pledge that there vaccine is ultimately successful, they will produce it essentially, meaning no profit for that company. Mister young, from pfizer, has already stated, for the rest of the witnesses, will you please answer yes or no, will you sell your vaccine and provide transparency so that we can verify a profit . Yes or no . We will not sell it at cost. Will not sell it at cost. Mene pangalos, yes or no. The agreement we have is 300 million doses, no profit. Julie gerberding, yes or no. He is your question about transparency as we reported since 2018, transparency in our pricing, weve not raise our prices since the pandemic began, we will not be selling vaccine at cost though it is premature since we are a long way. Macaya douoguih. We will be providing vaccine at a notforprofit price. Taxpayers have provided 10 billion through operation warp speed, no knowledge of how these resources are being sent. The company receiving taxpayer funding for your vaccines, have any of your contracts or agreements with the federal government included provisions to ensure affordability in pricing or vaccines or treatment . Let me start with stephen hoge. We dont have a supply agreement now we have a research and development agreement. That is what i am asking. Under our agreement for funding Clinical Development program with patient study in adults and children and funding 300 million doses Julie Gerberding. We are not receiving funding from warp speed at this time. We have 234 million in research and development for no procurement agreement. Macaya douoguih. Research and develop activities, we do not have agreement. Lets put this question out there. Mister young, your company has rejected taxpayer funding for your vaccine. I am concerned you made this decision to price gouge . Without question, will pfizer commit to affordable vaccine pricing or full transparency around research and development . As i mentioned, we didnt accept federal government funding, we wanted to move as quickly as possible into the clinic. We recognize these are extraordinary times at the time of the pandemic, consistent with what we are facing. We believe critically that the vaccine should be free to the public. People are unable to afford it. To ensure that many patients who do not face cross sharing, we certainly commend that. I hope you do find a cure and i yield back. I am told by the republicans, mister mckinley, recognized for five minutes. From what we heard, a vaccine could still be months away, parents have been synced to us they dont want to send children back to School Without a vaccine. Knowing what you know now, when you send your children or grandchildren back to school, yes or no . In the united kingdom, i will send my children back to school if the schools are open. I can say for myself, for local public school, to answer that question, i dont know the answer, parents across company trying to figure it out. Have you come to a conclusion . We are talking about that tonight. If you are confused think about all across america if they are following the guidelines, perpetuating this problem as we follow the guidelines. Other people on the panel can step up. I can respond, i had a conversation last night with a mother and two grandchildren in our family facing a situation where all three children or two children and the mother teaching and 3 School Districts may end up with different policies but there is a great deal of local availability, we need better science about the role of pediatric transmission in daycare, schools and colleges. The association said they should be back in school. I want to get your input because people are looking for you for leadership and how together schools to open up and if you are on this, given the Pediatric Association has already abdicated, given the work you have learned or the difficulties we have been dealing with with china where any of the ingredients in your formula . Thank you for the question. Pfizer and biotechs vaccine, none of the materials or drug substance will involve any part of the supply chain. We anticipate for our vaccine candidate, the Network Dedicated to the United States and ron materials and drug substance like pfizer be sourced in the United States in the case of some other important parts of our supply chain from canada, germany and the United States so no contribution from china. You want to resolve this pandemic globally. We kept our supply chains independent of each other, or the manufacturing will be done in the United States for manufacturers in the United States. Let me go to the third question. I was hoping it would be a yes or no. Already, chairman poll alone brought up the responsible allegation that your Company Might bring a drug to market before it is sufficiently tested. Are your companies insulted by that accusation that you could bring a drug to market that is not safe for effective . Is that insulting . Thanks for the question. Given the speed at which we are working it is understandable there may be questions about cutting corners. We are not cutting corners or lowering standards. I feel comfortable that vaccines are effective, in terms of getting ready for approval. Any others . We are working around the clock to accelerate our development but we are not cutting on safety. We believe that you could be accused that accompany of your stature that you could be accused of cutting corners. We were continue to develop safe and effective products. My time is expired. Mister kennedy is recognized for five minutes. I am grateful to you for convening the hearing, grateful to our witnesses. And developing a vaccine for covid19. What i want to ensure is sufficient political will and corporate courage to ensure that a vaccine is not only acceptable for patients and communities hit hardest by the coronavirus but distributed, choices, generations of elected officials and healthcare industry, led to the historic disparities that weve seen throughout the course of the pandemic. Back home in massachusetts our State Government in eight separate cities, hotspots, testing is lower. Chelsea, everett river, lawrence, marlborough, uneventful. In communities of color, wellknown at this point a direct correlation with them. Companies put forth enormous effort and resources in the development of vaccines but you havent been doing it alone, some of you received the backing of the American People through federal funds for support, half 1 billion for moderna, 1. 2 billion for astrazeneca. We have a responsibility for those investors as well. Decisions that express lifesaving medicines in communities and i would like to dive in a little bit about what your plan is. I want to begin with mene pangalos. Do you have a plan to ensure there is a coed distribution of adapting vaccine in frontline communities where we have seen rates of infection . Thanks for the question, this disease is having disproportionate impact that means diverse city. Our goal is to provide to all races and all people in the United States and around the world. To supply the 300 million doses, for the distribution. So is there a plan being put forward . I know you want there to be, have you developed one . What the state of development is . The administration determining that we provide how they wish to distribute them across the United States. The same circumstance, up to the administration to decide distribution. It is but we are prepared to share the plan we are working on which is based on an framework that puts us on the highest medical need, further discussion on that. Do you have a plan or not . Julie gerberding . Right now we dont have a plan because we dont have a product. I want to say quickly, the National Academy of medicine to really help adjudicate those allocation decisions independent of the administration per se. I agree that vaccine places the greatest need, to distribute the vaccine. Like my colleagues, we believe insuring a vaccine, i just want to believe the cdc guidelines developed a number of years ago that outline specific populations in those at greater threat is very helpful and look forward to working with the Administration Distribution should it be successful. 20 seconds left. The most resources including the finding, one of you have a plan, all of you can procure proper ppp including shortages across the country. With taxpayer dollars, we are 26 of people who rely on influence cant get access to it. You are distributing, clearly the federal government has failed multiple times over and i am curious if you dont think theres a problem for your companies when communities of color and low income communities dont have access to this, you will come back and have another hearing and we are grilling you. If you dont make some effort intentionally i would urge you to do so because the consequence of not doing it right will be dramatic for this country. Recognizes Mister Mullen for five minutes. I dont we are in a pandemic that weve never experienced before. Our country to find the vaccine. It is completely wrong. Can each of you speak to your manufacturing capacity and how ramping up to meet that demand will be needed once the vaccine, one at a time. Thank you for your question, john young from pfizer. I mentioned in my testimony we have a dedicated supply chain we are establishing for the United States in parallel that we are working with our partners to develop a supply chain, looking to leverage existing pfizer network and massachusetts and kalamazoo, michigan for the drug manufacturing process for drug products, the incredibly heroic work our colleagues have done as they begin work before we completed our phase 3 program to establish our manufacturing supply network. I am proud of the work our colleagues have done so far. Our supply chain, has done a phenomenal job putting facilities for our partners emergence in mri to secure doses this year and next year, we will continue to supply as needed assuming what is safe. Thank you. At moderna weve been working on the us supply chain for several years, go to the factory in massachusetts and recently partnered one of the largest manufacturers to use their facility in new hampshire, we are confident we can have several million doses next year. Manufacturing at risk. We expect hundreds of millions of doses in 2021, securing the supplies we need to support that. I can answer for johnson and johnson. We are setting up Global Supply, we entered partnerships with emergent so we can produce 400 million doses out of those facilities and we are setting up other areas entering agreements to supply the rest of the world with vaccine, targeting 100 million doses by early 2021. Can you tell me what is happening in china . It is not. Our manufacturing is domestic. Would you say the majority if not all of this is happening inside the us . 100 of our products are supplied from our usbased supply chain. Is that the same for anybody else . We have supply agreements so sourced from the us but others around the world will be supplied from other sources, keep supply chains independent with each other. Merck has committed to building out our supply chain to the tune of 9 billion prior to the pandemic and only adding to that count. Great. Roughly half of the people in the us, distributed around the world. 20 seconds left. Do you have plans to expand manufacturing capacity . Yes. Thank you so much, i yield back. Recognize mister ruiz for questions. After hearing for progress you are making in your efforts to develop an effective and safe vaccine, the numbers of the vaccines you anticipate having in the next year seemed promising, i am very concerned about the lack of Health Equity plan in the distribution of those vaccines. The number one step is the science of developing an effective and safe vaccine, to distribute the vaccine and four is to administer the vaccine on the front lines. We should be able to foresee what is coming and develop a Distribution Plan that based on Public Health principles with the objectives to slow the trend of transmission and to see as many lives as possible. When we ask those questions we need to ask where is the highest risk and highest rate of transmission of coronavirus and which communities and demographics are dying at a higher disproportionate rate of coronavirus and it is not too difficult to find answers to those questions. We know that seniors in Nursing Homes are at highest risk of dying, those with underlying conditions, we know that africanamericans, latinos, native americans are at highest risk of getting infected and also dying from coronavirus. We need Public Health principles based on Public Health equity, not politics, not for profit going to those who are the highest bidder, or an objective that favors the powerful, prosperous or the healthy or large corporations who can afford or offer the highest bidding amount in order to keep their healthy workers safe to affect their bottom line. We cannot repeat what has happened already in the distribution of testing, the outreach and treatment of the coronavirus. An employee told me or texted, that his sister who works on the front lines as a nurse, who was recently exposed, couldnt give testing herself and it wasnt offered in the hospitals, she had a vote to urgent care and it was difficult to get testing. He has a cousin who is in training, a professional baseball team, they get tested every two days. My office is hearing the same from nurses across my district. This is unconscionable and we cannot repeat this mistake with the distribution of vaccine. Having millions of vaccines is a good first step. We need to plan now how we get vaccines into the hands of the people who need this most. I dont want to look back and have Health Equity be an afterthought. It has to be prioritized. I want to ask Julie Gerberding what is your company doing to ensure the distribution of the vaccines are getting to the population that needs them the most of the highest transmission and the highest death rate from covid19. The best way to answer your question is to think through what works or doesnt work, the aci p, allocations but in the special case, many of us to create a mechanism that is a government, to give 100 of vaccines to the government. That market should create a Public Health principle and save as many lives, to include Public Health. Can you answer the question for me please . Doctor young from pfizer . Important question. I want to support what Julie Gerberding said. The cdc laid out very clear per syria criteria for how to prioritize and we look forward to working with the federal government and its agencies for the vaccine that is official if you could please mail my office and this committee your distribution priorities, not only go towards the government but that you have within your own private market sales and distribution and what your objectives are during this pandemic. Can you do that please . Yes we will. Mene pangalos, stephen hoge, Julie Gerberding, can you do that . A yes from all of you and i will follow up, Johnson Johnson as well. Thank you. The chair recognizes the Ranking Member of the full committee. Appreciate this hearing in the testimony of the witnesses. I have a couple questions. Just real quickly when we talk about the dosages that are available before the end of the year into next year, do all your vaccine candidates require two doses to be effective . John young from pfizer, thank you for the question. We anticipate the protocol we will study in our Clinical Trial, two doses. Is that true for the other witnesses . Remains to be seen. Earlier in our development, the possibility to evaluate both. Selected vaccine candidates that have reasonable possibility that is our hope at this point in time. Given this, the new protection we dont know whether one would be enough. Becoming one dose. For the public to understand, we had 30 million doses, probably should estimate that we cut that in half in terms of the number of people who get vaccinated in worstcase scenarios, that is my take away of that. In terms of the supplies you need and many of you talked about the ancillary supplies, packaging and shipping, assisting your companys in this endeavor, or the supply chain locked down to be able to produce, package, shift, safely and efficiently through more work of the administration of Congress Need to do to assist in that. The funding we are getting from the government, helping to ensure what we need, 300 million doses as rapidly as possible. We have what we need. When we say we anticipate hundreds of millions of doses. We had existing mechanisms for this procurement. We are working on Global Supply chain to provide what is needed. You are able to achieve that. We are monitoring the situation and would appreciate what is available. We have positive engagement with suppliers for Raw Materials, we believe we have all necessary materials for Vaccine Program should we be successful. We have procured all the we appreciate that folks at hhs have been doing contingency plans to secure this. I want to talk about fda for a bit. Are you comfortable with the guidance to protect consumer safety and ensure the efficacy of the drug . Anything that disturbs you or will rush you into production . I would commend the fda for being extremely transparent by the criteria they laid out for safety and effectiveness. Those standards are high and should give americans a lot of confidence. If the vaccine is approved, that the fda have done so according to stringent guidelines for which they are to be commended. Does anybody disagree with that . Thank you all, for the work you are doing to safeguard the world from this pandemic and bring about a vaccine. I yield back. The chair recognizes miss castor for five minutes. Thank you to all of you for being with us. One thing i want to make clear because we are talking about confidence of consumers and americans who have a great deal of stress and anxiety. Can you articulate, briefly if you can, the notion that because you are taking a risk on the manufacturing, that is related to speeded up the timeline of the vaccine, but you are not taking a risk as to the safety and efficacy on the Research Side . If you could, one by one, start with mene pangalos. Very good question. Absolutely right. So we have that data and the regulators agree vaccines are safe and effective we will have a supply in the us and around the world, what they give us. Typical vaccine production . You wouldnt be making these investments around the world before you have any evidence of efficacy. It is a huge help. I want to focus on the daunting task of ramping up production to provide doses for 320 million americans in a matter of months. This will be an unprecedented task, our Ranking Member has pointed out it might take two doses per person. I introduced hr 7104 which would expand manufacturing capacity and require the administration to begin this planning now because i believe planning is essential so that we can assure that all americans have equitable access to the vaccine when one is available and our communities can reopen fully and safely including our schools. This legislation was included in the house version of the heroes act and im anxious for the senate to move forward without delay. Mene pangalos, astrazeneca stated, producing 300 million doses of the vaccine beginning as early as this fall does that include the 1 billion doses it plans to supply around the globe . It does not. The us supply chain only, 7 billion doses supplying around the world with an independent supply chain around the world. Pfizer anticipates 100 million doses by the end of 2020, one. 3 globally in 2021. It is my understanding that pfizer has some challenges that resulted in shortages and delays, what steps is pfizer taking to increase capacity and mitigate risk of future shortages or equitable distribution issues . Since we have invested several hundred Million Dollars for production difficulties and quality challenges, proud of the work our Manufacturing Team has done and we are proud in the covid19 pandemics those sites responded to incredible increases in a number of important basic situations with covid19. That would be substantially remediated in 2019 and completed by 2020 and those sites were on track. They were from our legacy pfizer networks where we dont have a history of quality problems. My time is coming to a close. I thank the gentle lady and recognize mister burgess. I think the chair and ask unanimous consent to placing the record the letter from retract of all technologies about production of 240 million syringes with us being able to provide the delivery mechanisms doctor ruiz talked about. Along the lines of what doctor we use was discussing about the availability, the price of vaccines historically has not really been one of the big obstacles that are a big determinant in vaccination levels. We have had some hearings on the investigations subcommittee on the issue of Vaccine Hesitancy. At Washington State following the Measles Outbreak last year. I ask all our panelists, to encourage the American Public to make the vaccine when it was available. Why dont we start with astrazeneca . Thank you. Ultimately we know people need to be vaccinated from the pathogen and recognize the Vaccine Hesitancy, particularly what may be perceived as a problem. And the federal agency, safely and effectively, the fda commissioner has already committed to to showing the regulatory review process will not hold the highest standards. We are ready to support the cdc efforts and materials to encourage people in communities . It is a week point but i agree we engage the cdc, Johnson Johnson, same question to you. Vaccine hesitancy is a bigger challenge over time and it will be for covid19. The outreach and educational materials, we very much support any efforts that focus on valid Educational Programs to make sure people understand and share their concern, people need to have trust and confidence in safety and efficacy and have their concerns answered. I wouldnt worry about this more. Trust is a consequence of truth telling and transparency, not enough to have a government spokesperson, those are doctors at the local level, we have to engage the medical community, and help people get the information and have their own confidence in what we are doing so they can translate that at the community level. I couldnt agree more with the concern. We do think it will take a broad effort to make sure the vaccine is adopted. I would echo Julie Gerberdings commented that theres a trust deficit. Thank you for the question. Vaccine hesitancy is one of the greatest challenges for Public Health america faces. Support the work of the cdc and i have endorsed the comments of my fellow panelists and we need to play a role in ensuring that should we be successful in this mission, confidence and safety and effectiveness a vaccine based on data and the confidence that the fda will approve the vaccine if it is proven safe and effective and we support the work of this panel in achieving that end. The federal government has allied of initiatives and countermeasures. And with the Vaccine Development process. Yes they have been helpful. Thank you for that support. Yes, it would be extremely helpful and constructive in this process. Absolutely helpful. We wouldnt have thatss ebola vaccine approved and licensed if it wasnt for novartis. Dr. Hoge. Yes, absolutely, incredibly important. Mr. Young. Yes, we maintain very constructive discussion with a whole range of Government Agencies. I yield back. The gentleman the chair that recognizes ms. Castor for five minutes. Thank you, madam chair. That future witnesses are here today. I would like to continue the discussion about cdc and a Public Health professionals across the country and how we will distribute vaccines because i believe any successful effort to deploy the covid19 vaccine will rely on our Public Health professionals across the country here may have been on the frontlines of the pandemic from day one. Weve got to build on that longstanding Public Health infrastructure thats already in place across america, and while i believe its been drastically underfunded in past years, the congress has provided some resources to cdc and our Public Health departments, and the heroes act that we passed in the house months ago would build on that investment. State and local immunization leaders recently wrote to operation warp speed leaders just a couple of weeks ago, and they said our nation has a decadeslong track record of facilitating both public and private infrastructure to successfully deliver lifesaving vaccine. But im very concerned because the Trump Administration has not relied on our Public Health experts at a time when we need their guidance the most. I think, you know, their dismissal of scientists and Public Health experts of billy put folks at risk. I mean, i represent the state of florida and we are in a world of hurt right now. In fact, just this past weekend is reported the Trump Administration is trying to block necessary funding for testing tracing and the cdc to fight covid in the next emergency aid package. Getting a a vaccine that is sae and effective is going to absolutely critical, and i hope the president of those around him will consult our Public Health professionals. Dr. Gerberding, you are at cdc. You were a leader there and in your testimony you state we urge strengthening of the system that support routine immunization systems in preparing now to adapt them to mobilize for mass vaccination programs once the pandemic vaccines are available. Would you agree that the centers for Disease Control and the longstanding Public Health professionals across the country have been critical to our nations historical Vaccine Distribution efforts . And what role do you believe that cdc and our Public Health partners must play in a national covid19la vaccine plan . Thank you so much for your question. [inaudible] i hope you can hear me. And that is our teen urge and our adults. We cannot possibly do this without the cdc on the frontline of our state and local health department. We need to y strengthen their support. We need to strengthen their ranks, and we need to get fuly behind them, arming them not only with information about the resources necessary to reallyy step forward and support Mass Vaccination Campaign in the context of this pandemic. They are our frontline. I concur. That whole system has been very successful in the past to contain outbreaks, i mean, for h1n1 they delivered over 100 million1n vaccine doses durg the 2009 pandemic. Mr. Young, why will this existing Vaccine Network the essential for the covid vaccine, covid19 Vaccine Distribution effort . Thank you for the question. I endorse dr. Gerberding has just said. Plainly, the challenge that we face is enormous. In theory i think dr. Gerberding in her testimony already said none of us are sick until all of us are safe and that is what unique about the situation in the importance of the vaccine that gets to those threat greatest risk but ultimately that everybody is protected. And so the criticality of Publicprivate Partnership thats represented in this room today, actually the engagement of the Government Agencies and full Distribution Network to be able to get to potentially 330 million americans and ensure they are all protected is going to be absolutely fundamental. And dr. Hoge, is this coordination happening now . To your knowledge has operation warp speed leadership engaged in this kind of planning with our Public Health professionals across the country . So i cant speak to what operation warp speed is doing outside our vision but they are brought in colleagues from nih, cdc and other Public Health officials to help us both plan and execute her study of perhaps begin to anticipate happens if we end up with an effective vaccine. Thank you. I yield back. I think the gentlelady. The chair now recognizes this turducken for five minutes. Thank you, madam chair and what you think the witnesses for being here. Just some stats in South Carolina for population of 5,000,001 and 48,714 people, 8714 people, weve had 1164 deaths. Thats. 023 mortality rate in South Carolina, 89 recovery rate from folks that contracted covid and gone on to recover. Im glad we are pursuing this vaccine, but it just want to caution us to a few things. When i look at the data for an influenza vaccine and granted there the are many different strains of influenza that is also a fear that covid19 could mutate and a different strains but when i look up something weve been dealing with a longtime and thats influenza, we have to guess the review what strain will be there. If you look at the effectiveness come in 2019 it had an estimated or a 5 effectiveness in 2018, 29 effectiveness. 2017 was 30 . 2016 was 40 . 2015 was 48. 201415 was 48. 2014 was 90 effective. For vaccine that was created for influenza and a virus weve been dealing with a long time. Now we have a Novel Coronavirus known as covid19, and were trying to great a vaccine for it. Hopefully it wont mutate but when i think about influenza i think about the fact that it affects a very similar population, more so than others. That population being the older population, 60 plus a special if theres comorbidity involved. Influenza affects the same age group. When you look at the data of influenza, to use as a comparison, the vaccinations are effective most come higher percentagewise, healthy adults come 1846. Thats about 70 effective rate. Healthy children age six24 months come 66 effective rate. It also protects against other infractions with the benefit of 1545 . Where it is not effective is that population 60 and above. Especially when comorbidities are involved. Lets shift to covid19. Or try too create a vaccine for covid19 and my question for every company is how would you create a back vaccine that is effective for the most vulnerable population, and that is the 60 plus population especially when theres comorbidities, comparing to the influenza vaccine about that demographic as well. How are you going to target the most vulnerable population if you look at the for tablets of covid19 . Answer that. And then how will it be delivered to those. Thats another question but lets talk about how you going to argue that vulnerable population. Ms. Gerberding. Its a really important question. At the very beginning, Vaccine Development, w we tend to stay vaccines in the people that have the greatest likelihood of responding to the vaccine, but we do need to understand what will happen in the vaccines in older people. Thats one of the reasons we will ultimately end up with more than one vaccine. The first vaccine may not be the best vaccine for seniors or for children, so we need to have additional studies to find the value o in the highest risk population and the safety of the occupation. Will for a thats a very important question. During my studies, we will create a variety of age groups from 5yearsold to 70 plus and so we will be able to generate an indication of his best responding to the vaccine will. Regulators said they wanted a 50 level in the population but or if the younger population response better than the older population, we dont know yet. What we do know is will [inaudible] we are optimistic it will work in older adults. We also have additional double the independent of generating the new response. If theres a immune compromised individual or someone that doesnt respond to the vaccines to the street and antibody instead, injecting those 50 immune response my time is about up. The weve always shared your respect with the elderly populations we want to evaluate them in the very first study so we can understand what the immune responses are and what the safety profile looks like and the schedule so that we can evaluate them in the efficacy study as well because they believe they should be some of the first people to get access to the vaccine. We do have experience in the platform and other viruses will there is a good possible depending if you succeed without population. Thank you for the question. Two quick answers because i know we are running out of time. Weve already evaluated the vaccine and the elderly populations that is the phase one and two study we look to publish in the future. In the phase three study we stratified the study. 25 to 40 of the folks over thee over the age of 65 of comorbidity. Especially with [inaudible] thank you, madam chair. Mr. Sarbanes is recognized for five minutes. Thank you, madam chair. Can you hear me flex yes. Excellent. I want to thank the panel for all of your work and obviously for your testimony today. I want to drill down a little bit more on the tension between safety and speed that you have spoken about a number of times. Of course all of you have testified that you dont have to sacrifice of safety to achieve the speed with which youve undertaken right now. But it sort of begs the question will be what happens in normal times because i know for example you have said to investors will leaning on you more quickly to get a vaccine produced or some other product that will you have to go deliberately for safety reasons, so can you maybe, doctor gerberding, doctor young, the two of you from the panel cant tell me exactly why it is that youre able to move fast without sacrificing safety when we weigh that against the normal procedures would be . Will is it that you are now putting the staff on this 24 hours a day, whereas normally youd be working a 12 hour shift . Is it that you have resources coming behind you from the government that you dont normally have that allows you to move faster . What are the actual logistical dimensions of what it means to go past but stay safe . I can start. You mentioned some of the categories. The biggest timesaver is the fact the we are already investig and building the manufacturing capacity, literally the plans that will be manufacturing the vaccine. As we said normally that doesnt happen until after weve proven that the vaccine works. So that takes a huge chunk of time out of the preparation. In addition, the collaborative efforts such as the nih is creating and bringing together Industry Leaders along with scientists to try to define what are the leading candidates so we dont waste time and resources prosecuting a portfolio that isnt going to go anywhere and concentrate on the most promising opportunities. I think the fda is doing a lot to make sure the portfolios are reviewed in an expeditious manner even putting the guideline out as a great help to us because it creates more regulatory certainty about what we need to come forward with in the portfolio. We know we need six months of safety data for example. So, all of these things added together chimed together the timeline with. That assumes things will go exactly as we plan and i think those of us that are experienced with vaccines know that that isnt always the case, simply dont want to overpromise on the timeline and that is one of the reasons they are cautious about that. Let me jump in and ask another question. Im going to give it a little bit here, but its related. Let me say to the point that you made i think you are describing how this pandemic may be completely changing us, the way vaccines are produced and approved and tested and so forth for life after the pandemic. Obviously this is an unprecedented situation, but its forcing a change in the design of how we do this which will be relevant on the other side of it, and i think its interesting in the moment even to step back and consider what that means will. Let me pick up on your point about expanding the manufacturing capacity ahead of whether you know you are going to need it because that is going to be a timesaver and maybe will i know a pfizer executive recently indicated even if the companys vaccine is successful, they will pivot and dedicate whatever capacity its going to help produce what is successful. So maybe doctor douoguih then you can speak to whether the astrazeneca has a similar posture on this that you are going to step up and be part of the manufacturing capacity solution regardless of what happens with your own vaccine pursuit will. Thats a very good question, and i think we can make ourselves available for this type of discussions if the vaccine turned out to be successful we would have the capabilities to produce. Its something we would entertain a discussion on an absolutely. Doctor mene pangalos. Weve been having conversations with the administrations around our overall manufacturing capacity. I know weve already with [inaudible] using contract manufacturers to help provide a 300 million doses of. Thank you. I will yield back. The chair recognizes his books to five minutes. Thank you madam chairwoman and thank you for holding this hearing. I wish that all of america could actually be listening in and that is part of what i want to ask everyone. And thank you all very much for your work. Doctor burgess already brought up the fact that his committee has looked at the issue of the vaccine has a tendency to competence in a recent poll showed as few as 50 of people in the United States are committed to receiving one of your vaccines with another quarter wavering. So why continue to be really concerned about what we all are doing relative to Vaccine Hesitancy so im really curious what your specific companies approaches are, whether its how you market it, communicate it can educate a disastrous and Public Health professionals about the efficacy of the safety of the vaccine because as you can see theres been a lot of questions about that. And i will start with my friend and fellow chair of the Commission Doctor gerberding if you could share with us what merck is doing, i know you talk about truth telling and so forth, but what is it the companies are doing specifically to help educate the American People, and i would love to hear from everyone. Doctor gerberding. Thank you for mentioning the commission. We appreciate your support in that regard and all of your efforts on behalf of our security. Its a long answer and perhaps i should bring some of this back to you for the record the short answer is that it really does have to do with grassroots as much as it does talk down and that means getting out in the community. For example, dealing with health disparages means we go to the frontline. We are actually supporting through various local ngos the opportunity to bring information to people, to encourage them to seek care, to try to catch up with the vaccinations that have occurred here now at risk for a measles pandemic because of under immunization. So it is the grassroots on the ground supporting the medical providers and Community Leaders on their terms, bringing them information. As the chief officer, i had a roundtable with various Patient Advocacy groups listening to what they know, but their concerns are and how can we broker better information exchange. Thank you. Doctor mene pangalos, anything with astrazeneca any different . The other piece we need to do is be transparent about debates weve generated. Weve been telling patients for post two years vaccination and will speak to different age groups and it is safe as well as effective. Doctor douoguih. The efforts we can start now in terms of education and outreach, i mean of course we have to develop a safe and efficacious vaccine and be confident that the data we are presenting our shared and understandable and digestible in ways people comfortable and accepting a vaccination. But i do think the communities that are disproportionately affected might require more engagement, and that is a process that needs to start now so they can even consider participating in Clinical Trials i think favors participation also gives credibility to the safety and efficacy of the vaccine and forms the foundation for the work that has to come after that. I want to make sur sure evere is able to say what your company is doing. About transparency and the data we need to create information that allows monitors to make recommendations to patients and our focus right now is making sure that we have a business to be on the diversity and we are partnering with a number of groups and the nih and others with outreach to leverage of those advisers to communicate with this population. Thank you for your question. A question for all my panelists have made will, data transparency is one of the commitments we have made early on in the pandemic will. The Clinical Data as we generate and that will continue to be important. Like some of the other companies here we are also looking to ensure our study is represented in the disease for the covid19, for the recruitment of minorities, women, or patients and the studies can be imported and that is critical so when the trial completes that physicians and the Scientific Community and others are our birthright to jacob grassroots of america is a sexiness and approved. Thank you very much. I would remind you all most of us are not physicians were in the medical community, so if you can educate us all in the best language possible its appreciated. Thank you for your work and good luck. I yield back. The chair recognizes mr. Peters for five minutes. Thank you to the witnesses for being here. Im sort of at the end, so i have questions that must have been answered. Thank you for the good work you are doing in developing this vaccine and of course we wish you the best of luck. A couple things i didnt hear that i want to ask about our interactions with the vaccine. While the patients in the ordinary course and be able to get this vaccine at the same time as the flu vaccine and when will we know if theres dangerous interactions tend to e vaccine and other medications . Anybody. Will during the course of clinical studies around the world, weve been looking at all of the appropriate drug interactions and comorbidities etc. That you would need to publish more and get a regulatory filing you would need to be aware of that. It will be discovered during the clinical studies we are running. Also i think youve spoken at length about who will be orderly and i guess the question i have is whether very young kids are going to be about to get or use this vaccine. Are you testing that vulnerable population as well as the older folks in the phase three trial fax at a pediatric study that will be ongoing in the United States in addition to the older population of the teamyearolds to 70 plus. The we are planning to initiate a Pediatric Program if there is evidence of efficacy i of the adult population. Will vaccine is available later for those populations than the older folks. We need to understand what the schedule is and they immune response that you dont need and efficacy study population to be able to send the appropriate safety and immune response data. In a couple minutes i have left, what are the issues that have come up with the country not being prepared for this, availability on shore, the materials they need . Obviously, ppe was a topic of conversation, ventilators i want to ask about the basic pharma. One of the basics that hasnt been available and tha that hasy become generics, not the ones who are involved with in the United States will in terms of Domestic Production but the most produced overseas in india. I ask each of you for your thoughts on how the United States should make sure is hard available on shore when we need them in case of a second wave for the next pandemic. Thank you for your question. The question of availability and quality are the critical ones for every Healthcare System around the world and that is something certainly we would like to play a part. I mentioned earlier in response to the previous question the Manufacturing Network in the United States had seen a significant surge in the number of those will will that are vital to the care we have seen volume six of ten or 15 fold for some of those. We believe it is absolutely critical and we are committed to the supply network of. We have colleagues that are based of the u. S. And we are committed to try to honor the question is. The representative of johnson and johnson, more specifically how would you suggest that we as a committee and the congress to strategize getting thstrategizec drugs, many of which are generic and on shore for the next pandemic fax will be the co . I dont know if im the best to answer that. What i can say is we are committed to providing our product and making sure the people who are already on those medications have access to those first and foremost and those who are at risk are next in line will. So far we are monitoring and making sure we are able to provide the pharmaceuticals weve marketed. I appreciate your thoughts and i yield back. Thank you. Are you going to go to the members of a thank you all for joining us. I will start with congressman of a 5050 opportunity an 50 thank e opportunity and to the witnesses for coming today and thats a treatment and i want to thank john known for coming to talk about the great work that they are doing. We got great news from the 58th actually last week. Thursday i had a chance to visit the manufacturing facility in my district where they are already gearing up to make their vaccine. Its amazing how quickly youve been able to mobilize something so huge in this short period of time. They had received the message from the irs to spend whatever it takes to get this done so just a quick question for doctor young. Can you take us through the whole manufacturing process will and the idea that we would have the supplychain start to finish at least for the 40 million doses that they were planning to produce and a symbol before the end of the year, can you walk us through that will . Thank you for the question. If the manufacturing supply chain than the three sites that we have in the United States will each have a distinct role to play. Specifically responsible for the development of the template which essentially is just that. That will is then used to create particles so you have a small piece inside this microscopic droplet that has been designed to be taken off and then it will be put into the finals of a patient vials and then the drug will be taken into the supplychain and will be distributed to hospitals and clinics all around the United States. We are excited about the work thats being done today and i would underscore the comments of my colleagues. We do have a lot of hard work ahead of us but thank you for the question. A quick question on something else. The next trial is going to start literally in the next week. What is the earliest assuming everything goes well, if there is not a glitch, what are the Safety Standards if the Safety Standards remain the same, what is the earliest that you think you might be able to see the use authorization but what about the unleashing of the produced tens of millions of vaccines to the American Public . Thank you for your question. If all goes well, we hope to provide to the clinical leader in the studies to the fda in october. They will then review the data and determine whether it meets the requirements so weve already laid out ahead of time what weve determined for the authorization so they will make the decision and review the data for our vaccine and potentially other vaccines represented here. Sometimes the Fourth Quarter potentially we would have the data to make the decision. Thats why weve invested early in the supplychain in order to be able to deliver up to 100 million commercial doses of vaccines in 2020 and up to 1. 3 billion doses of vaccine in 2021. And my remaining time what they say of course you were the two leaders on the vaccine [inaudible] can you tell me how is reaches the production of the vaccine ex we support the work that you and the chair have done in the 21st century. I think it really helped to inform jasmine was the funding mechanism for the fda to lay the groundwork for the regulatory innovations that have been applied during covid at a recent Pilot Program for the Clinical Trials of. The familiarity with the realworld evidence. Its on some of the measures of the 21st century at the health established and i believe we should continue to build upon the indices advances. Thank you very much to the committee for your support and for your leadership. I yield back the balance of my time. Next we have congresswoman eshoo. I would like to thank all of the witnesses. Ive listened highly attentively with the exception of going over to the capitol to vote. Thank you for your work and the speaker of the house says on a regular basis dot finance will be in is the answer to our prayers. What you are doing is one of the most important undertakings to Public Health i think in this country. So thank you. Doctor mene pangalos, astrazeneca has applications in the United States, but its a britisthe britishcompany. These uk standards are different or they differ from the fda. How are you going to meet this challenge . Is a Global Company we get our medicines approved throughout the world on a regular basis. Thats how businesses reach nations around the world. Its set by the u. S. Fda and for the manufacturing of Development Perspective we are also working would there be a time difference between whats approved in the uk and what you woulwhen theywould seek to haven the u. S. . Hispanic that would depend on the data each of the countries use to get its approval, so we have ongoing studies in the united kingdom, the infection rate is low and they also have some in south africa and brazil as a part of the Regulatory Authority is working as fast as they can with us, and ultimately the data from the studies will give approval around the world. Thank you very much. I know that the Ranking Member of the committee, mr. Walden, asked a question about dosages, whether there would be one or two, and i want to follow up on that. If there arent too, ho are twot the baby . Most reports that ive read half 55 and older in their trials, but in order to there is something about the dosage. If you are dosing for 55 and older, its like the influenza shot, you need a superduper one to be effective and get for younger patients, for children, young adults who, you dont need that higher dosage. How are you all going to handle this . I cant remember who said they thought theyd have to do to doses, so maybe the two dose companies can answer about. Do it quickly. Youre absolutely right different populations may require different schedules. The First Priority is to demonstrate efficacy and the best way is maximizing the dose. And then to reduce to the singledose so we will start with two almost definitely. Are you th argue that ones anticipating the two dose is . The we anticipate thats what weve studied in the trials to date. We end up with a single construct dosage for both older and younger into the effectiveness. I note you are not a scientist but by reputation you are a humanitarian so i will salute you for that. Why did they choose not to take any government money and take it all on your selves as well as the risk . Great question. We recognize as the world is in a completely unique situation they also recognize that and have the experience we have in the company we are in a unique place to put our own capital at risk to move as quickly as they can get while making sure that we maintain a focus on safety for thank you into the chairwoman and chairman of the full committee. All of the witnesses. Let me put it this way. Godspeed. I yield back. Thank you. So we go to members of the subcommittee first. So mr. Tonko has returned so hes next. I yield to the gentleman for five minutes. Can you hear me . Yes. Thank you, and thank you to the subcommittee for ranking this hearing and to our witnesses for your participation. This committee has held many pandemic preparedness hearings over the years, and with consistently heard that the manufacturing of enough ancillary supplies needed to go with vaccines such as vile biled syringes and of the materials come its an essential component for administering the vaccine. Now rememberad what happened ths Spring Estates and hospitals scrambled in computer for basic as critical supplies like masks. So now as we look toward an unprecedented effort to manufacture a vaccine for the entire globe there their increg concerns about thee availability of all those ancillary supplies needed for a vaccine. With so much riding on a vaccine we cannot put ourselves in that situation of widespread shortages of critical supplies when it comes to vaccinating people around the world. So mr. Young, if a vaccine is approved, we meet in ancillary supplies to administer hundreds of millions of doses in a compressed timeframe in this country alone. What steps are you taking out to ensure that you n will have thoe sufficient supplies . Thank you for your question. As i mentioned in my testimony we have engaged early to deploy capital and put contracts in place at risk with our suppliers. Suppliers. We have engaged with the suppliers and also doing a lot of work to invest in the development of that supply chain that would be critical to get those miles from our manufacturing sites to clinics. All of that work is requiring capital which would appoint at risk. Really good thing we have done is engage early and invest early and thats in the supply chain. Thank you very much. Dr. Pangalos, presumably every company in the world working on a vaccine will be competing for these scarce Vaccine Supplies but you state in your testimony quote none of the Companies Involved in this project uses the competition against each other, arsenal adversary is covid19. My question is, is astrazeneca coordinating with other companies on this production of procurement of vital supplies or will you be competing against each other for them . Thank you for the question, congressman. First of all we are using different technologies which means theyre not competing for the same Raw Materials. I think that is a benefit i would say from astrazeneca perspective with gritted our supply chain and when theyre not competing with each other so have a supply chain for the United States, supply chain for the uk, supply chain for europe and his wife jane for international region. As a consequence they are protected from one another and we are ensuring each one is robust in its own right. Our supply chain in the trade supplies 300 million doses under agreement is working with an oversold but also with contract manufacturers make in u. S. Such as emergent. We feel confident in the quality and strength of our supply chain in the United States. Thank you. As i mentioned this past spring it was chaos estates and hospitals scrambled to outbid each other for scarce ppe. As word from governors who testified before our committee, federal government did not effectively coordinate ppe distribution at the national level, and in some cases made it much worse. So dr. Hoge, moderna received 53 million im told from barter specifically to expand its manufacturing capacity. What guidance or coordination is your company receiving on the federal Government Regarding the production and availability of vaccine insular supplies, and is a goingci to be again a situatin where every company is going out there for itself . Thank you for the question. We like other companies have in working with suppliers specifically purchase all the necessary answer supplies you mentioned including stoppers and wipes. But weve been working with barda directly with the great you just mentioned providing transparency and depend on those perches of the context of what were doing. The purpose is twofold. It gives them confidence that we have redundancy in the supply and we do have what we need but it gives transparency to view Us Government on where we are purchasing though supplies and certainly if the unfortunate circumstance arose there are vaccines that successful i would imagine all of those would be made available to other vaccines if they were successful. Thank you very much. I thank all of our participants. The availability of the supplies necessary to administer a successful vaccine will require coordination and im pleased to hear some efforts are underway but has supply failures by this administration makes me very wary. With that, mr. Chairman, i yield back and thank you. Thankie you. Next is mr. Carter is recognized for five minutes. Thank you, mr. Chairman, and thank all of you for being here and thank you for your efforts. These are extremely important and i dont need to tell you that come your understand how important this is and we appreciate all the efforts that are being madeia here. Ive always said theres a a difference in knowing something and realizing something. We have known for quite a while now we are to depend on other countries for ourur medical supplies. But during this pendant i think we realized, and one of the things i said we realize is 72 of all the active pharmaceutical ingredients in the u. S. Supply chain are manufactured in different countries. In fact, a more than more than 150 countries. In 13 comes from china alone. We witness this as well in march when india even without 26 drugs from exportation. This is a serious issue and i think we should do everything we can to increase domestic manufacturing. In fact, i have legislation that will incentivize pharmaceutical manufacturers to bring their manufacturing back to america. I want to talk specifically about the vaccines at it wanted to ask each of you specific to your vaccine how much of the material that is used in your individualal vaccine, in your product, comes from overseas . I will start with you, dr. Pangalos. U. S. Supplies, part or you supply chain come from the United States. All of it . Yes. What about the other things that he used such as files are the delivery methods . Anything at all, even packaging . To the best of my knowledge all of the materials were using for years supplier coming from the United States but i can check that and confirm it for you. And are you manufacturingng e vaccine in the United States, is that your intention . Yes, we are. Okay. Okay. Dr. Douoguih . Yes. So 99 of our materials come from either the u. S. Or europe. We have various little coming from inside china. In terms of how much manufacturing we have in the u. S. , its roughly half of our supply will be produced [inaudible] and the other half would be produced in europe . Well, there will probably be a number in order to best support Global Supply of our material. Any in china . As far as i know, im not aware of that but these discussions are ongoing. Okay. Dr. Gerberding . Thank you banquet at get back to you for the record on this trip with prosecuting to vaccines, and while generally speaking we are vaccine come with several, very much localized to the United States in a couple places in europe. I need to come there are the entirety to make sure if you could get back to us and right i would appreciate it. Dr. Hoge. Are manufactured domestically is at two facilities in the trade, the vaccine is made entirely in the tourney. Our supply concludes a number of Raw Materials some of which event source internationally but we were to supply that and bring it to depots in advance of needing it for manufacturing. Ginger defined internationally . Does that include china . I do not believe so but i a lot from europe europe. Im circumdoes that include china internationally . It may include for some of the raw material but it dont believe it is i a major compone. Most of what i was describing was a europe. Okay. Y. Mr. Young, finally you. Thank you for the question. As i mentioned we will have dedicated supply chain for a vaccine if successful for the United States. The raw material for our vaccine drug substance are prepared and manufactured in the United States. Our drug substance is made within our pfizer networkta is s the files them go to healthcare professionals. Good. Doctor young, while i have you here the fda has released the guidelines outlining the conditions for approving the covid19 vaccine. The believe these are fair and other achievable, particularly given the timeframe we are working in now and the element of these vaccines . Thank you again for your question which i believe is critical while openly suggesting the issue that it think were talked about previously. I think the fda are to be commended for very proactively releasing guidelines that are evidencebased, very clear clear and transparent around the standards of data they will look, expect for both safety. They should give a lot of confidence to every american that a vaccine is approved is going to be high for safety and effective. Thank you for that. Just as curiosity does anyone disagree with that . No. No. No. Good. Im out of time, mr. Chairman. Thank you very much and i will yield back. I think the judgment. The charter recognizes mr. Holler ran for five minutes the chair now recognizes mr. Holler ran for five minutes. You are muted. You are a muted. Thank you madam chairman. I think the Witnesses Today for doing so much to educate the American Public about the potential for a vaccine in the coming months. Six months ago today the cdc reported the first case of covid19 in the United States. In the months that followed American Life has been upended as we face an unprecedented Health Crisis. Lack of ppe which still plaguing our Healthcare System, and with no clearly defined coordinated strategy. The administration testing and contact tracing. The virus is continuing to spread throughout the country. Congress has a lot of money, allocated money for testing for contact tracing, yet without a court need National Strategy come significant lapses [inaudible] obviously, while not directly related, it is important for congress to ensure that similar distribution, accessibility problems do not occur when a a vaccine is deemed safe and effective [inaudible] covid19, i encouraged by some of these early trials and hes vaccines, and im hopeful that the later phase trials will prove the vaccine is safe and effective for mass production and distribution. However, the accessibility of to americans, all walks of life, is critical, and that is where i want to focus my cases of search across arizona, across america and some of the earliest hotspots occur on tribal lands in my district. For far too long the government responds our tribal nation to ensure they have the proper ppe and other equipment. My question is to the entire panel and we will go right to left. I know you all are currently in different stages of testing vaccine. If youre planning for later trials with more people come what is your company doing to ensure that there is broad representation across racial and ethnic groups among participants . Are there any difficulties that Congress Needs to be aware of as this next covid19 package is being negotiated . When i i sit across racial and ethnic lines, i would like to understand a little bit from each of you what the complexity of that means. I will start, and thank you for the question. We absolutely support making sure that our vaccine in Clinical Trials is tested and is diverse as possible to ensure that we have dates they give us that will be effective in the community represent all the populations around the world as was were running studies in united kingdom, in south africa and south america, and in the United States, and also considering going to other regions also such as japan, china and elsewhere. Th but ultimately we need to ultimately we need to make sure within the unitedma states alsoe have diversity in terms of communities and population we are testing and working with nih will make sure we do have the diverse population that represents both Ethnic Diversity as well as age diversity. Thank you. Next, please. I can go next. We are still in the planning stages of our phase three study but we i do plan to include diverse population not only from an age perspective but many communities you mentioned. To do that we are launching a Community Outreach program that will involve a digital platform but also leveraging some of our existing networks and connections in the context of some of our other programs. For example, weve had a a very long history of the hiv vaccine trial work with the nih and their networks, and have a very Strong Community Engagement Group that is very active in the communities you mentioned. We want to work and partner and leverage the experience we have because those population are also disproportionately affected by covid, to make sure theyve information about the disease and the vaccine trials we are planningwe and ample opportunity to determine if you want to participate. Its in the past expense will use to help improve the diversity in our triumph. I think im going to run out of time so ideal. Thank you. Thank the gentleman for yielding. Do have any other members who im not seeing on my screen who have not had an opportunity to ask questions . Seeing none, i want to thank all of our witnesses for the participation in this very important hearing today, and i think i speak for all of my colleagues on both sides of the aisle when we say we wish you well, we wish godspeed, we wish the development of desperate of course the challenge would be producing it and distributing it and convincing everybody to take it. I want to remind members that pursuant to the Committee Rules they have ten Business Days to submit additional questions with a record to be answered by witnesses weather. Before the subcommittee. And i would ask all of our witnesses to please agree to respond quickly and probably do any questions that you may receive. I would ask unanimous consent to insert in the record by the following documents, the report from the republican staff on vaccines and therapeutic stated july first, 2020, and a letter for Fractal Technology to dr. Burgess dated july 4, 2020. Without objection, so ordered. And with that, again, thanks to all of our witnesses and the members. Take you for being, thanks to mr. Pallone for filling in when we all had to go vote, and with that, the subcommittee is adjourned. Coming up a hearing with peter gaynor in response to the coronavirus pandemic and the House Oversight committee here on cspan2. [inaudible conversations]