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

Help contain the largest Public Health crisis the nation has faced in over a century. The extent of the crisis cannot be overstated. Six months, over 3m people in the United States have been diagnosed with covid19 and more than 140,000 americans have died. Sadly these numbers will only continue to increase as new covid19 cases are searching all across the nation. 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. They expect to be in the trials for both of the products, but we wouldnt expect to have a licensed product until 2021 at the earliest. Thanks to all of the witnessethis is iappreciate thet recognize the Ranking Member for five minutes for the purposes of this question. Thank you very much. I want to be able to make sure you have time to answer, so in the safety and effectiveness, doctor fauci had a testimony last month saying we are not risking safety for science and its important for each of you on your trials could you explain with which they wer which they g sacrificing safety and efficacy and what specifically is the company doing to ensure the safety and efficacy of the vaccine and could you tell why in 12 to 18 months when currently the fastest vaccine was months and took four years. Im going to try to manage i believe we can do this. Its unprecedented times but its how people working 24 7 mark. By the end of the studies that will be i think a very significant number. Sorry for the quick response. We believe it is possible to deliver a safe and effective vaccine. We have accelerated programs weve developed. A lot needs to be done in parallel but it can be done without compromising. Any of the standards we usually undertake for any Clinical Trial. There may be a need to perform surveillance and they are working on a plan to continue to monitor safety not only before, but after for the duration. We will continue to monitor the dish would be feasible to do this. Thank you. Doctor gerberding. Thank you. Merck has a long experience there are special safety concerns that have to be watched for including enhancement of the respiratory disease in this pressure to move as quickly as we can to accelerate the Safety Assessment and we are quite relieved even in these emergency conditions they would apply to any of the vaccines we prosecuted in the past. I echo my colleagues comments weve been working across the clock with colleagues outside of the company as well to make sure we are doing it in an incredibly responsible way all the way through. To conduct a 30,000 phase three program demonstrating the safety and the vaccine to the fda. Thank you very much. Pfizer is completely committed to ensure the safety and effectiveness of the vaccine and we are able to move quickly and we are fortunate we were able to pay for a couple years worth of basic science and that along with our partners, biotech or the vaccine platform. As mentioned i think the American Public should take the guidance that clearly [inaudible] that they are going to expect the companies to demonstrate to the standards regardless of the timing for thank you very much. My time is expired. That is very comforting to hear. I will yield back. Let me say that all i heard was what some of the previous speakers said and historically ive been very confident in the fda but now trump is president , there is a possibility that he will pressure the fda to lower the standards either by putting out new guidelines that say they dont have the standards but right now they see the vaccine has to be 50 effective. Lets say, let me give you a scenario the fda changes its guidance and says it only has to be 20 or 10 effective. Yours is only ten or 20 effective and that they approve it anyway saying well, you know, you dont. What im trying to do to rely on usa manufacturer to kind of assumed the fda wonassume the e highest standards either by changing the standards or by saying its okay, when you know it isnt. And they are proving e drug only 20 percent effective. Do you feel an obligation to tell us that and give us that information . Doctor . Thank you very much. Thats an important question. And then to regulate that. And secondly looking at those inadequacies first and foremost. But regardless of what the fda says or does we could have some sort of assurance from you and others that you would tell us the truth about the effectiveness. Absolutely. So remember this is a vaccine use globally. Now lets ask the same thing assuming you find out that you know is not 50 percent effective can you give assurance you would tell us the truth regardless of fda approval . Thank you for the question. We have a profile that outlines the characteristics from the development of our product with the vaccine efficacy. And look at the target product profile we would make those results available and then to bring forward a product. I appreciate that. How word you report any adverse events once its available for use . Im trying to get some answers. From the new england journal publication we expect to do that similarly regardless if its successful or not. To me in collaboration day has the monitoring board that would be adjudicated both the safety and efficacy. Thank you all i appreciate your responses and now i yield to the Ranking Member for five minutes. If hes not there may be he went to vote . I know. Do we have another republican . It with the chairman and Ranking Member guthries question that the fda guidelines were sufficient june in this year so do your companies believe the position to ensure safe and effective vaccine . Thank you for the question i would like to reaffirm my comments previously that the fda should be commended for publishing clear and transparent evidencebased guidelines on safety and effectiveness. The Clinical Trials will follow those guidelines and that we have great confidence with the American Public and congress that should be for safety and effectiveness. And a you answer the question sort of that i wanted to clear up any confusion. What is the fda requiring of your company during the Development Process are there details that can quell concerns . One way to think about this the fda is not loosening any standards. So business as usual has to meet these rigorous standards so when we were looking at the ebola vaccine portfolio it took five years until the fda finally approved the vaccine and then to maintain a rigorous standard of safety. We are familiar with the expectations were prepared to be transparent about any safety signals and with that efficacy that we have served. And with those normal standards. I appreciate that. Anybody else want to answer that question . We also agree those are appropriate and that criteria so to be sure we are developing appropriate studies and followup to look at the safety and the efficacy. In looking at the gold standard. Thank you very much. Speaking earlier about this question im happy to hear from others as well. Have you learned anything in the process . With the future flu vaccines to make it efficient and more effective. And more quickly when we know what is coming at us. And with the leverage with our partners. And that potentially lends itself and that the coding then that could be more quickly than would be the case. The vaccine with an antigen or pathogen of infection. And that we hope from that. Quickly can you tell the folks back home what it is . And the code to produce proteins and we can use that technology to with an antigen potentially to enable the development. Thank you madame chairman. The recent gallup poll shows nine out of ten americans are concerned drugmakers will take advantage of the pandemic to raise prices. So countless other examples and then they will price gouge patients making it impossible to get their medications so to ensure the safety on the safety and efficacy that it will mean nothing if its a barrier to all americans getting it. So to the witnesses the trade association there is a number of companies that have already made public that if there vaccine is ultimately successful they will produce it essentially at cost , meaning no profit for that company. Pfizer has already stated about the profit so for the rest of the witnesses answer yes or no. Will you sell your vaccine at cost and provide transparency so we can verify. We will not sell it at cost. We will sell to the government not at a profit. Yes your question about transparency as we have reported 2018 in our pricing we have not raise our prices since the pandemic began. Know we will not be selling it at cost but its premature because we dont understand the cost basis. We will be providing vaccine at the notforprofit price during the emergency. Taxpayers have provided 10 billion to operation warp speed but have no knowledge of how these resources are being spent or to receive taxpayer funding. Have any of your contracts with the federal government included provisions for affordability in pricing or vaccines for treatment . Doctor . We dont have a supply agreement we have a research and development agreement. Our agreement just over 1 billion for the Betterment Program for adults and children the wheel provide no profit for astrazeneca. Living just under 40 million. And to cover the research and development activity. I am concerned that you made this decision to price gouge will pfizer commit to affordable vaccines with transparency around research and development . Thank you for the question. As i mentioned in my earlier comments solely for the reason and in answer to your question the these are extraordinary times in pricing will reflect the pandemic and with that Global Health emergency we are facing and we also believe it should be free to the public it is meaningless if people cannot afford it and i went to applied congress and we certainly commend that. I yield back. I by the republicans. For what we have heard today vaccine could still be months away they dont want to send their children back to School Without a vaccine. So knowing what you know now, would you send your children or grandchildren back to school . Yes or no. The United Kingdom if the schools are open if i dont know the answer yet. Have you come to this conclusion . If youre confused think about all across america following the guidelines what about the other people on the panel . And with the mother and two grandchildren. In all three children and the mother is teaching three Different School districts and policies but there is a great deal of local variability with the role of pediatrics. I just want to get your input so given that Pediatric Association so given and by what we have learned with those difficulties would any of the ingredients come from china . And the potential sunny part of the supply chain and the Raw Materials and then the United States and the important parts of the supply chain from canada and the United States so no contributions from china. This is a global pandemic. Let me go to the third question already chairman for the responsible allegation that your company just as kids that they could bring it to market like for you can and the speed with which we are working it is understandable. And what you are hearing and we wont lower that standard so those vaccines that are effective and then would be good to go. Any others . We are working around the clock to accelerate development. Is that it is insulting that you can be accused a company of your stature that you can be accused of cutting corners. We will continue to build safe and effective products. Thank you my time is expired. Mr. Kennedy is recognized for five minutes. Thank you mr. Chair. Grateful to our witnesses for being here as well. No doubt our country is capable of developing a vaccine and courage to ensure a vaccine patience and communities hit by the coronavirus but also distribute them as well. And with those elected officials that has led to those historic disparities we have seen during the course of the pandemic during the spread of this virus. Back home in massachusetts to have eight separate cities as hotspots where the infection is high and testing is lower. And higher rates of minorities and there is a direct correlation somebody has put forth enormous effort but as has been pointed out is not doing well. Some of you anyway using federal funds for support and three. 2 billion from astrazeneca. You all have a responsible to those investors as well and the committee is trying to right the wrongs that have cut life saving medicines out so what is your plan . Do you have a plan to ensure the distribution of the vaccine should you come up with one and in particular communities. We appreciate that a disproportionate of those communities and in my testimony our goal is to provide for the United States and around the world in the United States to provide 300 million doses with the distribution of the vaccine. Im running out of time but is there a plan put forth . I know you want that but have you actually developed one . Know the administration is determining how they wish to distribute that. And youre saying its up to the administration to decide . It is. However we are prepared to share our information with the ethical framework and we have further discussions on that topic. We would be grateful. Do you have a plan . Right now we dont have a plan because we dont have a product but we will. Very quickly to count on the National Academy of medicine to help those decisions independent of the administration. We agree we support that entirely also we rely on the government. Thank you for the question like my colleagues we believe if a vaccine is approved it is critical we believe the cdc guidelines were developed a number of years ago specifically for those populations at greatest risk we look forward to working with the administration for the distribution. Just so we are clear all of you are relying on the government with ppe and with the taxpayer dollars and still 26 percent of people to have access to it. And to be seen multiple times over and i am just curious if you dont think there is a problem for your company so buyer beware i would urge you to do so because the consequence of not doing this right will be dramatic for this country we have to do this right i yield back. The chair now recognizes for five minutes. Real quick i think were in a pandemic we have never experienced before more than any other country out there and then to find a vaccine it is completely wrong. So can each of you spent on kenny to be speak once said is authorized you can take it one at a time. Thank you for your question and we were publishing and in parallel with our partners to develop that supply chain to use leverage and that they are already completed with the manufacturing supply network. But we are very proud of the work the public has done so far. And with those facilities and academic partners and then to supply 100 million doses this year than the first half of next year. We have been working on a dedicated us supply chain for several years now and we recently partnered with the largest manufacturer and through that dedicated supply chain we are confident we can use them from next year. And speaking for merck we are manufacturing now we expect to have hundreds of millions of doses by the beginning of 2021 and we are procuring the supplies we need to support tha that. With Johnson Johnson we have entered partnerships so we can produce 1 million doses coming out of those facilities and also setting up agreements to supply the rest of the world with 100 million doses by early 2021 and 1 billion by the end of the year. Can you tell me if any manufacturer is done in china . It is not. We have a us supply chain. So the majority if not all of this . Pfizer 100 percent of our products will be supplied from the usbased supply chain. The same for everybody else . We have supplies around the world we have sourced around the world that they will be supplied from other sources so that is not competing and conflicting with each other. We are committed to building out our supply chain in the us 9 billion prior to the pandemic and we are adding to that now. Johnson johnson what the supply chain distribution around the world. So in 20 seconds so the majority or are all of you are manufacturing in the us . Yes. Yes thank you madam chair. I yield back. The senator recognizes mr. Moody for five minutes. Thank you for being here today i am cautiously optimistic after hearing the progress you are making with a safe vaccine while the numbers you anticipate seem promising i am very concerned about the lack of Health Equity plan in the distribution of the vaccine the science of developing a safe and vaccine but number two is to produce the vaccine number three is to distribute and the number four to administer the vaccine on the front lines. We should be able to foresee what is coming to develop a Distribution Plan based on Public Health principles with the objective to slow the trend the transmission and save as many lives as possible when we asked those questions then we need to ask the question where is the highest risk and highest rate of transmission for coronavirus which community and demographic dies at a higher disproportionate rate of coronavirus . Is not too difficult to find the answers to those questions. We know seniors and seniors in Nursing Homes those with underlying conditions we know africanamericans, latinos, nate americans are at the highest risk of being infected and dying from coronavirus we need Public Health principles based on equity and not politics or notforprofit going to the highest bidder for an objective that favored the power for the healthy with large corporations who can afford the highest bidding amount to keep the healthy workers safe to affect their bottom line. We cannot repeat what has happened already in the distribution of testing and outreach with the treatment of the coronavirus i was just called by a previous employee yesterday who told me his sister who works on the front lines in the covid19 unit was recently exposed could not get tested herself. Wasnt offered in the hospital. She had to go to an urgent care and pay for it herself. But yet he has a cousin in training for the washington mets professional Baseball Team and they are tested every two days. My office heres the same thing from nurses across my district. It is unconscionable we cannot repeat this mistake with the distribution of vaccine we also need to plan now how we get the vaccines into the hands of the people that needed the most i want to look back and Health Equity is an afterthought but it has to be prioritized so what is your company doing to ensure the distribution gets to the population that needs them the most with the highest transmission and death rate from covid19 . The best way to answer the question is what works and doesnt work it is the cdc responsibility that makes decisions about allocation and many of us have called to look at Health Equity to be sure the allocation. I have heard thats the government. But not all of you will give 100 percent of your vaccines to the government. That you will fall back for the private market as well and that should also follow a Public Health principle to save as many lives and stop the surge to improve the Public Health. Can you answer that question please . A very important question. We believe the cdc made very clear criteria for what should be prioritized and working with the federal government and agencies to ensure that distribution if every single one of you can mail my office in this committee your distribution priorities that only toward the government but also within your own private market can you do that please . Yes we will. Yes. Can you do that . Yes. I will follow up with you as well. Now we go to the Ranking Member of the committee. And with the opportunity to talk before the hearing but first of all quickly talking what word be available do all of your vaccine candidates require at least two doses to be effective . Thank you for the question. Is that true for the other witnesses . So in our development. With those selected vaccine candidates there is a possibility to be a single dose vaccine but that has not been proven at this point in time. We dont know ultimately if we will or not. It could become one dose thats important for the public to understand what 30 million doses and then we cut that and half in the number of people that can get vaccinated in the worstcase scenario. In terms of supplies that you need the ancillary supplies like packaging and shipping is the federal government assisting your company with the supply chain lockdown to produce packages safely and effectively and efficiently what do we need to do to assist . Do you have everything you need to get those doses as rapidly as possible . We think we have what we need. When we say we anticipate hundreds of million doses Going Forward thats from the ancillary supply we are big Company Making a lie the vaccines for procurement. We are looking at the Global Supply chain to provide why it is needed. Youre confident you can achieve that . So far it looks that is the case but we are monitoring the situation closely. We have engagement with our suppliers we believe we have all the necessary materials to be successful. We do appreciate those at hhs to develop a contingency plan. Talk about fda are you comfortable with the guidance they have issue to protect consumer safety and ensure the efficacy of the drug . Are you concerned somebody will try to rush you into production . Other than being extremely proactive for both safety and effectiveness and that should give people a lot of confidence that they have done so according to stringent guidelines. Does anybody disagree with that . Thank you all madam chair i yield back. Thank you very much madam chair. One point i want to make clear because we are talking about confidence of consumers who have a great deal of stress and anxiety, can you articulate the notion because youre taking a risk on the manufacturing speeds up the timeline of the vaccine but you are not taking a risk to the safety and efficacy on the Research Side . But we are doing to have that vaccine with that data and the regulators agree it is effective in the us and around the world. How much time do you think that takes off the clock of the typical vaccine production . You would be making these investments around the world before theres any evidence of efficacy. And looking at the daunting task ramping up production. This is an unprecedented task and as the Ranking Member has pointed out that could take two doses per person and then to expand the manufacturing capacity requiring the administration to begin planning now. So we can assure all americans have equitable access so to fully and safely including schools. And in the heroes acted very anxious for the senate to move forward without delay. Astrazeneca has stated 300 million doses of the vaccine beginning as early as this fall. Does that include what it plans to supply around the globe . It is the us supply chain only. 137,000,004 around the world . Pfizer is producing up to 100 million doses by the end of 2020. And one. Three global the 2021. Its my understanding pfizer had challenges with injectables and manufacturing resulting in shortages and delays. What steps are you taking to mitigate any risk of future shortages or equitable distribution issues . Thank you for the question. And then to mediate production and we are proud of the work our Manufacturing Team has done and with the cove and 18 pandemic and then to respond in those increases of important basic injectable so the plan was in 2019 completed by 2020. I am pleased to say we are on track. And we dont have any history of any quality problem. Let me ask unanimous consent. And then with that delivery mechanisms and thats part of the availability and historically have not been one of the big obstacles and vaccination levels because at the very beginning of this congress to show the Vaccine Hesitancy and then build to increase or decrease hesitancy are there additional steps to encourage the public for the vaccine . Lets start with astrazeneca. We know people need to be vaccinated to protect them from the pathogen with the us federal agencies. To be safe and effective and already committed to sharing those highest standards we have talked about. And then to support the cdc efforts. And that was identified in as a weak point. I do believe we have to engage the cdc. And those with covid19 with the outreach and discussions and all of that needs to happen now and with those efforts that focus on those Educational Programs to share their concerns to have trust and confidence. Thank you i could not worry about this more so the truth telling is not enough to have a Government Spokesperson that we really need to engage that are trusted at the local level so how the people get the information so they can translate that at the community level. I could not agree more with your concerns we do think it will take a broad effort there is a trust deficit. Thank you for the question for one of the great challenges for Public Health. We fully support the work of the cdc in a can all play a role to be successful in this mission with the safety and effectiveness of the vaccine based on the confidence the fda will approve the vaccine only if it is safe and effective. 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. They have been extremely helpful and constructive during the process. Absolutely helpful. And to have the ebola vaccine if not for novartis. Yes absolutely. And to have very constructive discussions with a whole range of federal government agency. I yelled back. You are recognized for five minutes. And then to distribute vaccines. And then to rely on our Public Health professionals across the country that have been on the front lines of the number one. With that longstanding Public Health infrastructure that is already in place across america. I believe it has been drastically underfunded the past Years Congress has provided resources to the Public Health departments and the heroes act would build on that investment. Leaders that recently wrote the nation has had decades long track record to facilitate public and private infrastructure to deliver lifesaving vaccines because the Trump Administration has not relied on Public Health experts at a time we need the guidance the most so there are dismissal puts folks at risk i represent the state of florida and we are in a world of hurt just the past weekend it was reported the Trump Administration is trying to block necessary testing and tracing in the next emergency aid package. Getting a vaccine safe and effective will be absolutely critical and i hope they will consult our Public Health professionals. Doctor, you are a leader at cdc and you say we urge the strengthening of the system to support routine immunization systems for those programs once those vaccines are available. Word you agree the cdc longstanding Public Health professionals across the country have been critical to the nations historical Distribution Efforts . What role do you believe the cdc in Public Health partners must play and a national covid19 vaccine plan . Thank you for your question. I hope you can hear me. [inaudible] and to be at the front line of the state and local health departments. We need to strengthen their support and to get fully behind them arming them not only with information but the resources necessary to step forward and support a Mass Vaccination Campaign during the pandemic. They are our frontline. That whole system has been very successful in the past with h1n1 developing all those vaccines why where this network the essential for the Vaccination Efforts . Plainly the challenge that we face is enormous and the testimony you may have already been said that is what is unique about this situation but ultimately everybody is protected. And other Public Health officials to plan how to execute the study and anticipate what happens next. The chair now recognizes mr. Duncan for five minutes. Thank you madam chair and the witnesses for being here will. For our population will weve had 1164 deaths. If it is. 0 to 3 of mortality rate in south carolina, 89 recovery from those that have contracted covid and have gone on to recover. Im glad we are pursuing this vaccine, but i just want to caution us to a few things. When i look at the data for an influenza vaccine and granted there are different strands of influenza but also a fear covid19 could mutate but when i look up something weve been doing for a long time we have to guess every year with the strain will be in if you look at the effectiveness it had an estimated 45 in 2016 was 40 , 2014 was 19 of. One we are trying to create a vaccine for it. When i think about influenza a population of 60 plus especially if there is comorbidity involved. It affects the same age group when you look at the data of influenza that uses in comparison to vaccination for effective most percentagewise in healthy adults aged 18 to 46. Thats about 70 effective rate. Healthy children 66 . Influenza also protects against other factions of 15 to 45 . Were it not effective if the population is 60 and above especially when comorbidity is involved. So lets shift to covid19. We are trying to create a vaccine for the covid19. My question is how will you create a vaccine that is effective for the most formidable population and that is busted b population especially when there is comorbidity. The influenza vaccine isnt very effective for that demographic as well. How will you target the most formidable population if you look at the pickup of these of covid19 in the fatalities of covid19 or. Lets talk about how you are going to target 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. We go to the members of the subcommittee first. I yield to gentle man for five minutes. With will we have consistently heard the manufacturing of the supplies needed to go with that is an essential component for administering the vaccine. We all remember what happened this spring as they competed for the critical masks. As they move to the unprecedented efforts to manufacture for the entire glo globe. With so much riding on the vaccine we can find ourselves in another situation of widespread shortages and critical supplies when it comes to vaccinating people around the world. So, mr. Young is a vaccine is approved we may need enough ancillary supplies for hundreds of millions of doses in a compressed timeframe. What steps are you taking now to ensure you will have sufficient supplies clocks for thank you for the question. Get engaged to deploy capital. In the supplychain going to be critical from the manufacturing sites and clinics. All that work is requiring capital so thing weve done is engage early. Thank you very much. Presumably every company of the world working on a vaccine will be competing for this. But you said and i quote none view this as a competition against each other. Our sole adversary is covid19. So, my question is is the astrazeneca coordinating with other companies and will you be competing against each other to . For thank you for the question, congressman to. They are not necessary to compete for the materials so i think that is a benefit and i would say we have created our supply chains in a way that they are not competing with each other so we have a supplychain and the United States in the uk and europe and international regions. As a consequence to that protected from one another and we will ensure that each one is robust in its own right. Working with contract manufacturers based in the u. S. Such as emergent and we would feel confident in the supplychain strength of the United States. The states and hospitals scrambled and as we heard from customers that testified before the committee of th, the federal government did not effectively coordinate the ppe distribution of the National Level in some cases it made it much worse. So, moderna received 53 million told specifically to expand. What guidance or coordination or your companies receiving regarding the production and availability of the vaccine and ancillary supplies, and is that going to be, again from a situation where every company is going out there for it self . Gimmick thank you for the question, congressman. Like other companies weve been working to purchase all of the necessary supplies that youve mentioned. But weve been working under the office you mentioned the purpose of that is twofold. It gives them confidence that we do have what they need but it also gives transparency to the Us Government on where we are purchasing the supplies and a circumstance that i would imagine all of this would be made available to other vaccin vaccines. Thank you very much. I think all of the participants. Some efforts are underway but failures by this administration makes me very wary. With that i yield back. Thank you. Next mr. Carter is recognized for five minutes. Thank you, mr. Chairman and all of you for being here. These are extremely important. You all understand how important this is and we appreciate the efforts that are being made here. Youve known for quite a while now we are too dependent on other countries for our medical supplies. During this pandemic i think we have realized it. One of the things that we realized is 72 of all of the active pharmaceutical ingredients in the supplychain are manufactured in different countries. In 13 of we witnessed this as well in march when they withheld 26 drugs from exportation this is a serious issue and i think we should do everything we can. I have legislation to incentivize to bring them back to america. I want to talk specifically about the text theme and ask each of you specific to your vaccine how much of the material is used ithat is used in your il vaccine or product comes from overseas . For thank you very much. It will be coming from the United States. All of it . What about the other things such as delivery methods and packaging . All of the material that we use but i can check that out in a moment. Are you manufacturing the vaccine is that your intention yes, we are. Okay. Doctor douoguih. 90 of the material comes from the u. S. Or europe will. In terms of how much manufacturing we have come its roughly half of the supply produced. Than ththen the other half we produced in europe . There would be a member to support the Global Supply of material. Annie in china . As far as i know i am not aware that the discussions are ongoing. Doctor gerberding. Im going to have to get back to you on the record. While generally speaking, and we have several that are very much localized to the United States is our manufactured domestically the supplychain includes a number of materials some of which are international but we look to secure the supply and bring it in advance of the manufacturing. Does that include china . For i do not believe so, sir. Im sorry does that include china internationally lacks if they include some that i dont believe that its a major component. Most of what i was describing with europe. For the vaccine and drug substance and manufacturing in the United States its made within our network. Okay, good. While i have you here, the fda released the guidelines and conditions for the covid19 vaccine. Do you believe that these are fair and achievable particularly in the timeframe that we are working in now and the development of these vaccines . Thank you again. It is of critical and they are to be commended for releasing guidelines evidencebased for the safety and effectiveness of a vaccine is approved it will meet high standards for safety and effectiveness. Thank you for that. Out of curiosity, does anybody disagree . For no. Thank you very much and i will yield back. The chair now recognizes for five minutes. You are on me wit mute. Thank you madame chairwoman for doing so much to educate the American Public on the potential for a vaccine in the coming months. Six months ago today the cdc recorded the first case of the covid19 in the United States. In the months that have followed as we face an unprecedented speed t no defined Strategy Congress has a lot of money if there is [inaudible] accessibility problems i encouraged him by some of the early trials and helpful. However accessibility in all walks of life are critical if that is where i want to focus my question. If. We will go right to left. I know that you all plan for the trials [inaudible] are there any difficulties Congress Needs to be aware of thank you for the question. We absolutely support making sure the vaccine in Clinical Trials tested. It represents all of the populations around the world is why we are running studies in the United Kingdom and south africa and south america and in the United States and the others suggest japan, china and elsewhere. But we need to make sure we are in the United States also that we have diversity in the communities and populations that we are testing it to make sure we have the diverse population that represents the Ethnic Diversity as well as age diversity. We are still in the planning stages of a study that we do plan to include a diverse population of only from the age perspective that many of the communities that youve mentioned. To do that, we are launching a Community Outreach program that were off the digital platform and also leveraging some of the networks in connection with who we want to partner because those populations are also disproportionately affected by covid to make sure they have information about the disease and the trials that we are planning i on whether or not thy want to participate. So this will hopefully improve the diversity of the trial. I will yield back. I thank the gentleman for yielding. We have any other members i thought seen on my screen but havent had the opportunity to ask questions . Seeing none i want to thank the witnesses for their participation in this 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 if we wish youu godspeed and the development of thought just one of more than one safe and effective vaccine that we can have we hope by the end of this year or next year and of course then the challenge will be producing it and convincing everybody to take it. I want to remind members that are presented to the Committee Rules that theyve submitted additional questions for the record to be answered by witnesses who have appeared by the subcommittee and i would ask all of the witnesses to agree to respond quickly to questions you may receive. I would ask unanimous consent to insert into the record the following documents in the letter for technology to represent july 4, 2020. With that, thank you to all of the witnesses and the members