Transcripts For CSPAN3 Hearing On Vaccine Research Development With Pharmaceutical Companies 20240712

Who i see on my screen here, until im willing your evil to return, documents for the record can be sent to Benjamin Taylor and the email address we provided to staff. All documents will be entered into the record at the conclusion of the hearing, and i want to inform all members and witnesses that we are expected to have a series of hearings on the floor all day today. I expect that what we will do is we will rotate through, so that both on the republican and democratic side, so that we will be able to continue to hearing as seamlessly as possible, when the chair has to go, mr. Pallone will preside, and vice versa mister guthrie, i would hope that the republicans can do the same thing. The chair will now recognize herself for the purposes of an Opening Statement. inaudible my question is, are you needed, chairwoman . I was muted because my staff is looking for my Opening Statement, which was not included in my briefing outlook. I will make my Opening Statement in just one moment. Mr. Pallone, since they are looking for my Opening Statement, i think i will recognize for you for your Opening Statement for five minutes. Thank you, thank you, chairwoman. Today, well explore the pursuit of vaccines that could help contain the largest Public Health crisis the nation his face and over a century. The extent of this crisis cannot be overstated. In just six months, more than 3 Million People in the united have been diagnosed with covid19, and more than 140,000 americans have died. Sadly, these numbers belong we continue to increase as new covid19 cases are surging all across the nation, fleming to nearly 80,000 each day. Covid19 has wreaked havoc on the countrys physical, mental, and economic wellbeing, particularly among communities of color and low income communities. Today, we will hear from some of the Manufacturing Companies who have been working with the federal government to develop a safe and effective vaccine, and im pleased youre all with us today so we can hear how federal investments are being used to find a vaccine, but i want to extend special thanks to your colleagues in Research Teams working around the clock to develop a vaccine. Ultimately, it will be the collaboration of your efforts, partnership with the administration, and the support of congress that will make a covid19 vaccine possible. Along those lines, i also appreciate the chance to bring some transparency to the Trump Administrations operation. This transparency will be crucial to securing the american Peoples Trust of the covid19 vaccine will be made available, only once its proven to be safe and effective. Congress is already taken action to support these final efforts. This Spring Congress provided billions of dollars for covid19 Vaccine Development manufacturing efforts, and other medical countermeasures. Two months ago, the house passed the heroes act. This comprehensive legislation which strengthened the nation the values fight the pandemic by altering the Strategic National stockpile, increase funding for recent development, and manufacturing of vaccines and treatments. It would also require the Trump Administration to submit to congress a vaccine plan identifying the activities being undertaken to manufacture, distribute, and administer covid19 vaccines safely. As i said, the house passed the heroes act more than two months ago, and yet the senate has failed to take about, even as new infection and death rates soar. This delay is compounded by the fact that so much more couldve been done to mitigate the impact of the disease. From day one, President Trump has done everything he can to minimize the severity of this pandemic, and to undermine his Public Health experts. The administration is still not developed a National Plan to combat the pandemic. It has no National Testing strategy, no one in charge of the supply chain, and little effort to invoke the defense production act, and we are again seeing a resurgence of the same problems that hamper our for spartans our sponsor efforts such as testing shortages, ppe and medical supply shortages, and attacks on Public Health experts. These problems will likely extend the development and distribution of a covid19 vaccine, as long as trump is president and we all want to covid19 vaccine to be developed as soon as possible, but before a vaccine is distributed, Public Health experts must ensure that it is safe, effective and available to all who need it. My fear is that fda will be forced by the Trump Administration to approve a vaccine that lacks effectiveness so, we must also ensure that our supply chains can safely manufacture the vaccine in the quantities necessary, along with the biles, needles, oranges and other products required to administer them. This committee has a long history of supporting efforts related to Vaccine Development and deployment, and im hopeful that if we prioritize Public Health and strategic preparation, the administration finally learned from its mistakes, that our collective efforts will result in these safe, effective, and accessible covid19 vaccine, and i would like to now yield the remainder of my time to the chairwoman of our house subcommittee, congresswoman and issue of california. Thank you for yielding, mister chairman, and good morning to my colleagues and to our witnesses. Each of you represents a great hope for americans and for people around the world, and speaking of hope, i cant help but, as we mourn his loss, think of our colleague john lewis, who always said, keep your eye on the prize, and i think that is really 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, to hug our loved ones, and to begin the process of recovering from the covid19 pandemic, but with that opportunity comes great responsibility to ensure that products are safe, effective, affordable and accessible so, i look forward to hearing from each of you today how youre going to maintain transparency and accountability for the american taxpayer and the american patient, how you are scaling up domestic manufacturing, your suggestions for a nationwide Vaccine Distribution plan and how congress can tackle pervasive Vaccine Hesitancy in our country. So, thank you again for each of you for testifying this, to the chairwoman of this subcommittee for holding this hearing, and i look forward to not only hearing from you but working with you, and i yield back. The lady yields back, thank you so much. The chair now recognizes the Ranking Member of the subcommittee for five minutes. Thank, you madam chair. I appreciate you for holding this critical and important hearing. First, we do have three members, i know i dont have to make a unanimous consent request, just for the record, and mr. Upton, miss rogers, and mr. Carter will be sitting in the room with the subcommittee. Thank you for holding this important hearing. Covid19 pandemic has been a tough challenge for our nation, but its incredible effort to develop safe, accessible, and effective covid19 vaccines gives me great hope, and we are on a very promising path of solutions. The unified effort by vaccine manufacturers, the research community, and federal partners to work with each other is remarkable and im confident that through this unity of purpose, cooperation, focus, expertise, and a tremendous amount of resources, our vaccine efforts will prove successful. Companies are using their own funds at their own risk to conduct research and developed vaccine candidates, and create more new federal manufacturing capacity. Some companies are putting up to one billion at risk. The federal government has poured billions more dollars into the vaccine effort. U. S. Government supporting several initiatives to help accelerate the development of vaccines for covid19. Two key initiatives are operation warp speed, and the accelerated covid19 democratic interventions and vaccines, otherwise known as the actor partnership. Operation warp speed was established to accelerate the development, manufacturing, and distribution of covid19 vaccines, therapeutics, and diagnostics. Under the act of Public Private partnership also aims to speed vaccines and treatment options. Testimony today from witnesses of leading covid19 maxine candidates will be vital interest to the American People. The companies represent a diverse portfolio vaccine platforms, with promising preliminary data. For example for one Company Reportedly provided all 45 its Healthy Volunteers with immune response to the virus and an early study. For those who receive two doses, antibodies were found at higher levels in those generally recovered for covid19. Astrazeneca my complete human trials by september, and greenlight have been produced to produce 2 million doses by 2021. In addition, theyre reportedly as positive news on the response scene from antibodies and seashells. Last month, some vaccine experts who expressed concerns of the Trump Administration might exert political pressure if you put a covid19 vaccine on the market before its ready, and they wanted assurances from the fda that a vaccine will not be authorized unless there are at least 30,000 people in each states three Clinical Study. It appears such assurances have been made by the Trump Administration. The leading vaccine candidates under the auspices of operation warp speed are required to enroll 30,000 participants in phase three trials. As doctor, fauci the director of the National Institute of allergy and infectious diseases, and i, age and doctor steven, hanukkah mission or fda, testified before the full committee on june 23rd, there will be no shortcuts on safety and efficacy standards. The speed is being achieved through the financial, risk the financial risk, i will repeat that, of manufacturers, not safety or efficacy, and accelerating their capacity to produce millions of doses, and not at the expense of safety in efficacy. Concerns have also been raised about Vaccine Confidence and whether there will be sufficient Vaccination Coverage to ensure heard immunity. We need to have a High Percentage of American People vaccinated to achieve the protective effect of heard immunity and save american lives. Regarding supply, and 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 millions of doses. I look forward to hearing more about how each of these companies today are planning to scale up their manufacturing efforts to ensure now to get an adequate supply of unauthorized or prove covid19 vaccine. Finally, on access and affordability, many manufacturers have told Committee Staff that if their vaccine effort is successful, they do not want cost to be a barrier to accessing a covid19 vaccine. This is a welcome commitment and we are eager to discuss it. The mission to get safe and effective vaccines, has been a driving force for committed republicans. The beginning of this month, we released the second pillar of the second wave project with the recommendations on how to better prepare production and distribution of vaccines and therapeutics. I welcome all of our witnesses and look forward to their testimony and discussion of these issues. Madam chair, i yield back. Gentlemen, the chair will now give her Opening Statement. This hearing will divot examine efforts to develop a safe and effective vaccine and i know i speak for everybody this morning in 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 long supported federal efforts in. Millions of the spring, we provided billions of dollars in new funding to support Vaccine Research, development and manufacturing efforts. Those nurses to some of the companies testifying today in developing covid19 vaccines. This committee has a responsibility for oversight. Today, we will have the opportunity to hear directly from some of the manufacturers working on potential covid19 vaccines horses and how the Funds Congress has provided are being put to use in these unprecedented times. I think the witnesses again for being willing to participate in such a critical hearing at a critical time. We are now six months into this national Public Health crisis and covid19 case numbers are continuing 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 shirk its responsibility, and lead exported National Response effort, sicknesses and deaths are going to continue. It is 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 radical Counter Measures including a safe and effective vaccine versus. Another containing this virus as soon as possible is of utmost importance. Drawings of americans may continue discontinued unemployment and loss of health insurance. Across the country, parents are making possibly hard decisions about childcare and School Participation and Frontline Health workers, essential 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 head in the right direction according to statements, this is from companies testifying today and the speed at which they are progressing for Clinical Trials, it is possible that a covid19 vaccine may become available by the end of this year or early next year. That is a rare bit of good news in this harrowing time, but while some Public Health experts are ghoulish on the development of a vaccine, we must blush we must remind ourselves that plenty can still go wrong, and so the anticipated timeline is determining a vaccines safety in efficacy is merely the first of the many challenges that must be addressed if we are to successfully manufacture and distribute a vaccine to americans and people around the globe. While we await the results of Clinical Trials, unnecessary manufacturing capacity and distribution infrastructure must be bolstered so an eventual vaccine is readily available for Many Americans once determined to be safe and effective. And as the pursuit of a covid19 vaccine speeds forward, we must be prepared, not only to produce the vaccine itself, but to have the supplies required to administer the vaccine, such as vials and surrenders. Last month, the Committee Heard from governors across the country just how unprepared we were as a nation to provide basic testing supplies like swabs and personal protective equipment. The lack of these supplies undermined our response effort, and we are still feeling the effects today. I remain concerned that with all the efforts around the world to develop a vaccine, governments in manufacturers lack of testing supply and ppe may all be competing for a limited supply of items such as glass biles and surrendered. The supplies are critical and ultimately delivering a vaccine. Further, now critical decisions must be made now across the federal government, industry and Public Health shareholders regarding vaccine road efforts and public and provide her education. This is especially true given the value of any future covid 19 backseat lies in the willingness of the American People to get vaccinated and their ability to access and afford it. Developing in distributing a covid19 vaccine requires a National Plan, one that the Trump Administration has stated still being developed, despite this committee urging the administration to adopt such a plan two months ago. But, times of the essence, and now is the time to prepare for a nationwide Vaccine Program. If developed, a vaccine will be instrumental in protecting the health and wellbeing of the nation. While we are all rooting for all of your collective success, we must make sure it is safe, effective, and ultimately affordable for all americans who need it. This committee will continue to conduct oversight to ensure these goals remain the focus of the pursuit for a covid19 vaccine. And with that, im pleased to yield five minutes the Ranking Member. Well, thank you very much, chairwoman. I want to thank you for holding todays hearing on an incredibly important and timely topic. I also want to welcome todays witnesses. We know you and your colleagues are hard at work to develop medical countermeasures including the vaccine that we are here to discuss today. You are literally working to save the world. We appreciate you taking time to participate in todays hearing. Congress can be republicans continue to examine issues related to covid19 and how to best purchase pair for an uptick in cases as the same time as the flu season hits us this fall. This past month, we were pleased to report with recommendations on the first pillar of our work, madam chair, which we would like to have entered in the record, earlier this month, we have released the second pillar focusing on vaccines therapeutics. This would include important recommendations that officials should have him as discussed in our report, there are extensive efforts led by the federal government, in partnership with department sector, to develop medical countermeasures for covid19, including operation warp speed operation warp speed this facilitating an unprecedented pace the development, manufacturing and distribution of covid19 vaccines. One of the many goals of operation warp speed is to have just under 300 million doses of a safe and effective vaccine for covid19 available to americans by january of 2021. The speed with which we have been able to identify vaccine candidates in a Clinical Trials are simply unprecedented. Put simply, this could not been done without the private sector play integral part of this herculean effort. The collaboration weve seen over the past few months between the federal government, the Trump Administration, and the private sector is truly extraordinary and i commend all those who are involved. But the committees june 23rd hearing we heard dr. Fauci say we are taking financial risks, not risks to save people. No risk for the integrity of the science, but the financial risk to be ahead of the game, make safe and effective Vaccines Available to the American Public. In addition to hearing today and update on the status of your effort to develop a vaccine candidates, we also want to hear, all this unprecedented speed does not mean sacrificing safety or efficacy. Along those lines, we also need to know how your companies are helping to build a vaccine complements in the u. S. This is a critically important topic that spans covid19 and beyond Vaccine Confidence. Remember once a vaccine is proven safe and effective and is authorized by the fda, we want americans to feel confident in getting that vaccine. This is also vital when thinking about the fast approaching fall and the intersection of covid19 and the influenza season. We need to see not only that a vaccine is available but also that it is accessible. For many communities are on the outside looking in. When it comes to covid19, no american should be left behind. As you will continue your work to provide a safe and effective vaccine, i asked you also take into consideration the need for a Robust Manufacturing Distribution Process for providing this vaccine in a timely manner for all americans. We also want to hear about your efforts to ensure there are sufficient amount of ancillary surprise to distribute vaccines to americans. This is another issue we need to be taking action on now, to ensure the availability of an authorized or approve vaccine to americans as quickly as possible. I want to thank you all for being here. If there are things you need help from the congress, we want to hear from you and do our part to be a good partner to provide this vaccine and therapeutics to the american citizens who are suffering from covid, or want to make sure they never get it. With that, madam chair, i yield back the balance of my time. Thank you, and the use and you need better care as you never said that Opening Statements be made part of the record. Without objection, so ordered. The chair also as we have several members of the committee who will be waving on to this hearing today for some, from the majority, congresswoman action years, congressman rick tierney, congressman ohalleran, and as we heard from the minority, congressman upton, congresswoman mcmorris rogers, congressman do shawn, and congressman carter. The witnesses to get i know want to introduce the witnesses for todays hearing. Clause doctor midday angela csection in Vice President biopharmaceuticals it already astrazeneca. Algae has called a bill and the head of Clinical Development and medical affairs chance for vaccines, of Johnson Johnson. Doctor julie govern, and good to see, you executive Vice President and chief education officer. Your doctor steven hoge pfizer sala, and the chief Business Officer pfizer. Thank you to all of you today. It is important here what you have to say. Now i know all the witnesses are aware that the committee is holding an investigative hearing and in doing so we have the practice of taking testimony under oath. Does anyone have any objections to testifying under oath through . This is let the record effectiveness have responded no. So the houses the chair than advise you that the rules of the house and the the committee. You are entitled to be accompanied by counsel. It is a new design to be accompanied by counsel during your testimony today . No. So let the record reflect the witnesses have responded no. Good news, im not going to make you rise, but if you will please raise your right hand so you may be sworn in. Its testimony do you swear the testimony that you are about to give is the truth, the whole truth, and nothing but the truth . I do. I do. I do. Let the record reflect that the witnesses responded affirmatively. You are now under oath and subject to the penalties under section 18, section 001 of the u. S. Code. The chair will now recognize our witnesses for five minute written summaries of the written statements. There is a timer on your screen that will count down the time, and it turns red when your five minutes is come to an end and so first im going to recognized for five minutes dr. Pangalos, you are recognized. Thank you, very much, chairwoman, Ranking Member guthrie and members of the subcommittee. Im doctor penguins and im privileged to be responsible for Research Development activity in the discovery and Late Stage Development for biopharmaceuticals therapeutic areas. Im here to convey astrazeneca strong commitment to ongoing efforts to develop and manufacture vaccines therapeutics for the prevention and treatment of covid19. You greatly appreciate the opportunity to engage in today on this important topic and i hope the upset is done on our dedication to finding safe and Effective Solutions to the covid19 pandemic in the United States and across the world. On our strategic approach comes from parting with sciences scientists, government, and manufacturers to establish the development and supply of the distribution of the vaccine in an equitable manner around the world, should prove to be effective in tolerated. To support our goal of providing brought access as quickly as possible, when weve entered into agreements with the United States and certain other governments in organizations, for the supply of hundreds of millions of doses of our vaccine. The cost of a dose of the vaccine under this agreement, will be provided at no profit to astrazeneca. The first like to provide some background on astrazeneca. We are a global signs and Biopharmaceutical Company with our north american headquarters in wilmington, delaware, and our local are in the headquarters located in maryland. We have over 13,000 employees in the u. S. Worthwhile operations operating in 12 states including in puerto rico, and in total, astrazeneca brits in over 100 countries and we are leveraging that global footprint and resources to address this worldwide crisis. Three core aspects of astrazenecas approach to advancing a novel vaccine and therapeutics for covid19. First, people in the astrazeneca seeking to develop an awful vaccine for the prevention of covid19, and has engendered license agreement with university of oxford for the global development, production and supply of their covid19 vaccine candidate, which we are now calling on in the United States, law to avoid the unnecessary loss of life, we are scaling up to manufacture of 300 million doses of the vaccine to be available immediately upon approval or emergency use authorization. Our agreements across the word, complies approximately two billion doses. One home run and we are partnering to support a broad, global and equitable access. We support the mission of agencies such as the fda to ensure that our vaccines are determined to be safe and effective based on sound science and data, before receiving any approval or emergency use authorization. Oh Patient Safety and health are and will continue to remain a top priority in this effort. Ive got an awful vaccine has begun late stage Clinical Trial is now based on data and clinical studies of phase one into Clinical Trials in over 1000 Healthy Volunteers in just yesterday, we announced some of the data from that phase one into trial, which showed a robust immune response at all the participants tested. We hope the results from our late stage trials later in the 50,000 volunteers will be available by this fall ball. Second we are advancing a combination of antibodies against covid19 for this product is going to be supported by Clinical Trials in the next few weeks. But investigating our prove medicine to see how they could benefit covid19 patients, particularly those severely ill patients. For example all one trial will assess whether we can produce the exaggerated immune response, cytokine storm, associated with the covid19 infection. But for law requires also to protect against organ damage in patients hospitalized with covid19. In addition to these efforts, we have donated 300 million asked to help their workers across United States and addressing this pandemic is an urgent priority for our company. We come to work every day focusing on this goal, that our efforts will save lives longer and around the world that would mitigate the consequences of the ongoing covid pandemic across the world. On behalf of astrazeneca, thank you for the opportunity to participate todays hearing. We appreciate your interest in these important issues and look forward to answering your questions. Thank you so much, doctor. Now recognize five minutes doctor douoguih, you are now opening recognized for five minutes for Opening Statement. Good morning, human chairwoman, Ranking Member guthrie and member of the subcommittee. Thank you for the opportunity to discuss Johnson Johnsons efforts to develop a vaccine for the virus that causes covid19. Thank you also chairman pallone, Ranking Member walden and other members of the full committee for joining this important discussion. I oversee Clinical Development of johnson and johnsons vaccines portfolio, including the covid19 programs. I would like to outline our efforts to develop a safe and effective vaccine and our public commitment to provide more than one billion doses at a not for profit price for emergency pandemic use working closely with health authorities, other agencies and academic partners, pursuing and johnson is pursuing an accelerated approach to the development of our vaccine, including largescale manufacturing, which we start in parallel with Clinical Development in, advance of, it actually soon to ensure the availability of quantities a vaccine if found to be safe and effective. We have formed an Important Partnership with the Biomedical Advanced Research and development authority, florida, under which Johnson Johnson will receive approximately 500 Million Dollars for covid19 Vaccine Research and development in these people barda. That supports these efforts which support clinical studies, and the production of Clinical Trial material. Our efforts progress rapidly since they began in january. In march, we announced the selection of our sars covid two vaccine candidate on the next. Next week we completed a creek preClinical Study in non human primates and have submitted the results to a period science journal. We look forward to the publication of those results in the near future you. We expect to start any of our first inhuman phase one to a trial later this month. This trial, conducted in the United States in belgium, will involve more than 1000 healthy adults ages 15 to 25 years and adults ages 65 years and older. We are anticipating preliminary result will be available in september. If those results are positive, we will plan to initiate a phase three trial that month. We are using our add that technology to develop a vaccine. This is the same technology that we used to develop our ebola vaccine, our vaccine candidates for ages to be hiv, our, spf zika. 75,000 in, having vaccinated many individual in a wide range populations including adults, seniors, infants, children and pregnant women. With respect to covid, we believe we can both accelerate Vaccine Development and control safety as we have successfully done with our ebola vaccine. As you may know, earlier this year, Johnson Johnson committed to bring its vaccine to the public on a notforprofit basis for emergency pandemic news. The notforprofit price will be based on one cost structure and will be validated by an external audit. Johnson johnson is also committed to including diverse populations in our studies. We are still in the process of designing our phase three trials and ensuring diversity is a key consideration for. For example, we plan to implement focus digital and Community Outreach to encourage diverse participation in our Clinical Trials finally finally, my written testimony as Additional Information regarding our extensive efforts to increase Production Capacity. At the same time, we are developing a vaccine so that we can produce more than one billion doses in 2021, at least 400 million which will be manufactured in the u. S. Madam chairwoman and, we recognize that this is a critical moment for society. Johnson and johnson is devoting are experienced energy and resources to develop a safe and effective vaccine for covid19 as quickly and as safely as possible. Thank you very much for the opportunity to speak with you today and i would be happy to answer your questions. Thank you so much, doctor. Doctor gerberding, you are now recognized for five minutes. You need to unmute. Thank you, chairwoman, i am really honored to testify today, and i thank you for holding this really important hearing. I also think the Frontline Health workers, including my colleagues at San Francisco general who are, as we speak, putting their own lives at risk while providing care to the ill people with sars covid two. They really are the true heroes of this pandemic. In 2003, i was serving as the cdc director pointy sars virus when large lost the first race in the hospital from world do the roadwork effort some of bitumen hospitals around the world. And unfortunately, nine people have lost more than 100 sarscov2 is a more formidable so. And weve already lost more than 140,000 americans and the virus is far from so, the race is on not against each other because this virus but unfortunately today, the pandemic is ahead of us but we in the bottom biopharmaceutical industry are closing faster than we ever imagined possible. According to the bio tracker, in the first six months, from the time we learned about the virus, more than 660 unique compounds are in various stages of development, including 173 vaccine candidates, 196 antivirus and 292 other treatment. But i have to compare that to age when it took more than six years to get the first hiv drug approved, and 15 years before we had finally active therapies. This astonishing progress is the result of a robust fraught biopharmaceutical industry and all the partners throughout academia and the worlds of investigation. Now, i believe this pandemic wont be the last or even the worst we will face so, we have to preserve a vibrant, innovative and economically sustainable biopharmaceutical business as the front line of our health protection. Failure to do so well jeopardize todays patient and degrade our future Health Security and. Finds liner side and i think science is on our side challenges as we approach the covid19 challenges from one, but these are still early days and there is much to be learned about this virus and how to safely combat it. America smirk is one of the few companies that has continued to invest in vaccines at anti invectives for almost our 130year history. Given that long experience and expertise, we knew what we saw this pandemic emerge that we had a special responsibility to help ended. When we looked at many possible vaccine candidates remain and we look for three main attributes. First, about a candidate that was based on a proven platform known to achieve 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 wanted a candidate these will to scale and distribute on a global basis. As a result of our search, we are pursuing to promising vaccines, one in partnership with abe, which is based on the same platform we used for our previous vaccine that helped contain the recent ebola Virus Outbreak in the drc, and also, a second vaccine candidate, one that we acquired from an acquisition, which is based on the measles virus, which has been used to safely immunize billions of childrens. As everyone has emphasized, speed is important, guys but we will not compromise careful scientific efficacy fall, quality, and above all, safety assessments, as we evaluate our candidates, despite the urgency that we all truly feel. There will be no safety shortcuts at merck this. Finding a safe and effective vaccine is only the first hurdle, and the second is even greater. We have to ensure the vaccines are accessible and affordable on a global scale. No one is safe until everyone is safe. Never in the history of humankind have weve been tasked with finding unaffordable vaccine for everyone. To put this into context, consider today, we cant even fully immunized the worlds birth cohort against vaccine preventable childhood diseases, despite decades of effort, or that despite hourlong awareness of the threat of an influenza pandemic, the annual Global Supply of influenza vaccines is far less than two billion doses, and most people in Resource Limited areas have no access at all. This merck does have a long track record of making our Vaccines Available and affordable to people around the world, and we are committed to ensuring affordable Global Access to any sarscov2 medicine or vaccine that we helped create. Our goal is to ensure that we can make these Vaccines Available to whoever needs them and we will prioritize that access based on risk and medical need. At the end of the day, access also requires trust, trust and vaccine safety, trust in the integrity of the vaccinate ares, trust in the medical efforts who assess them in times of crisis and trusting government. That is a tall order in most countries including our own and we have to prepare now to support peoples confidence. Thought at merck, we believe this is a daunting, but doable mission faces, and the purpose that motivated us to commit our lives to our profession. Thank you. Thank you so much, doctor. The chair recognizes doctor hoge for five minutes. Thank, you two members of the committee for the opportunity to appear before you today. My name is steven hoge and i service the president of moderna. I attended university at the university of San Francisco and briefly Service Position in a new york city hospital. My wife is also a doctor as are several members of my family, and i am proud to work for company focused on developing one of the vaccine candidates to stop this devastating covid19 pandemic. The pandemic has harmed millions of people. Our hearts go out to those who have lost loved ones or have been made sick themselves. Millions of americans are hard at work all of us have been profoundly touched by this in some way. We also know that communities of color in the working class have disproportionately borne the burdens of covid19. We must do everything we can to stop this pandemic. I would like to partake this opportunity to preside you with an update on our efforts to provide a safe and effective vaccine against covid19. At moderna, we seek to improve patients lives, by creating a new kind of medicine, based on messenger all rene or amara in a, i kind of molecule that plays an essential rule mrna. We are proud to be an American Company with headquarters and major manufacturing facility in massachusetts. Since our founding in 2010, we have built and invested in our mrna technology platform. This Technology Create synthetic messenger all rene sequences that sells recognizes that they were produced in body. Unlike traditional approaches to medicine which introduced a protein or chemical to the body, our approach sends tailored mrna into cells where the mrna instruct the cells to produce a specific protein. We believe this approach can improve how we discover, develop, and manufacture medicines across a wide range of disease. Because our mrna technology is flexible quickly adaptable, we step forward and pursue the Rapid Development of a covid19 vaccine candidate in january. We leveraged modernist technologies and years of research, that we had done before any of us had done before covid19 and collaborative with the Vaccine Research center and the division of microbiology knit that diseases of the National Institute of allergy and infectious diseases, to try to accelerate our vaccine candidate. These efforts started with a covid19 virus. We used information from the virus to develop an mrna sequence that struck the sales the patients body make the spike protein of the coronavirus. The bodys immune system then learns to attack the spike protein and generate a protective immune response. We progressed from didnt see quince of the vaccine into human testings in just 63 days, a testament to the ten years of investment and hard work on our platform. In march, the phase one study of our vaccine, which was led by the nih, had its first participant. Our phase one study had positive result and those findings have been published by the nih and others in the new england journal of medicine. Earlier this month, we completed enrollment of all 600 subjects in our phase to study and now, just over six months from the sequencing, and medina is about to become one of the first u. S. Companies to enter a vaccine trial for vaccine candidate. We have also been working to develop the scale of our manufacturing and distribution chains which should allow us to reach an annual Production Capacity of more than 500 million doses next year. Throughout this process, we have been focused on developing a vaccine that is as safe and effective as possible, looking to the science and the data to guide our decisions. I am grateful for the hundreds of scientists and other moderna employees whose hardworking sacrifice has made our progress possible. At moderna, we are also grateful to the Many Companies around the world, including all of my colleagues, here who are working on vaccines a treatment for covid19. We are also blessed to be joined in our efforts by dedicated Public Health officials and scientists, and a host of federal and state agencies. I would also like to thank the subcommittee for its commitment to this cause, as well as the diligent work of your staff. We are grateful for the actions you and your colleagues in congress have taken to support and fund the efforts to combat this pandemic, and we remain committed to collaborating with the u. S. Government as this process continues thank you, and i look forward to answering your questions. So thank you so much. You know im very pleased to yield to mr. Young, five minutes for your Opening Statement. Thank, you chairwoman, Ranking Member guthrie and members of the subcommittee, thank you for inviting me to testify today. Like my colleagues, im honored to be a part of this panel. My name is john young and i am the chief Business Officer at pfizer and have to do my work for over 40 years. At pfizer, our purpose is breakthroughs that change patients lives. In the face of covid19, this need is more urgent now than ever and weve harnessed the full breadth and depth of our colleagues expertise to help address this Global Pandemic. We know that safe and effective vaccines are pivotal, the food to serve the billions of people around the world impacted by this devastating illness. While data on the safety and effectiveness on a potential covid19 vaccine is still to be generated generated, we have a path to submit our Clinical Trial data and biologic license application or bialy to the fda as early as october of this year. Chairman and ceo recognize early that this pandemic was not business as usual. On march 13th we released our five point plan to help address the pandemic. First, sharing tools and insights. Second, martially our people. Third, applying our development expertise. Fourth, offering our Manufacturing Capabilities to support others and lastly, improving future rapid response. As we pursue a potential vaccine for covid19, between finding research and development and scaling up manufacturing capacity and risk, we expect to invest at least 1 Million Dollars here in 2020. To date, we have not accepted any federal government funding for the Vaccine Program as we recognize that we are uniquely positioned with the scientific in manufacturing expertise and Financial Resources to have the potential to deliver a vaccine without funding from the federal government. If our Clinical Trials progress well and we receive regular approval, we hope to be able to manufacture up to 100 million doses by the end of 2020, with 1. 3 billion doses in globally. Subject to a final those election for a pivotal study. We extended our existing partnership to develop a rna vaccine for flew to develop a vaccine for covid19 as both companies recognize this technology had the potential to be successfully applied to this disease. Diversity in Clinical Trials is critical for this Program Given that covid19 disproportionately impacted communities of color in the u. S. And to that end, ensuring that our Clinical Trials are inclusive of a diverse populations is a key priority. On july 13th, in the United States, two of our four investigational vaccine candidates we have already shared encouraging preliminary data from the most advanced of our vaccine candidates. This candidate could be administered in a dose it appears well tolerated, and generates just dependent immunogenicity. Yesterday, we also release Additional Data from our german phase one into Clinical Trial which further demonstrated encouraging t cell and cytokine responses. In the ongoing phase one into Clinical Trial we will identify a candidate and the optimal dose level for a large scale advocacy study up to 30,000 participants. We currently plan to begin that study later this month, subject to fda approval we are working closely with Regulator Authority to accelerate the program while maintaining the highest standards in our Development Process. In order to reduce the normal time taken for such a Development Program, we are doing steps in parallel, rather than sequentially, which requires more capital to be deployed. It is the only way we could have significant time for the Development Program while maintaining the safety of a key priority. In the event that a Clinical Development program is successful, we have already begun the work to scale up production for Global Supply we have announced that visor facilities in st. Louis, missouri, and hand over massachusetts and columbus who, michigan will be sights in our supply chain. Finally, our goal remains to bring a safe and effective covid19 vaccine to as many people as possible globally, as quickly as we can i have great confidence that our industry can prevail, in the outcome of our battle against covid19, and that science will win thank you. Thank you so much. It is now time to the questioning. The chair will recognize herself for five minutes. Everybody knows the time of his up the essence in the search for a covid19 vaccine, and obviously everybody wanted as quickly as possible, but we need to make sure that it is going to be safe and effective against the virus as well. I want to ask each of you your quick an honest assessment on the likelihood of success of the vaccine candidates, and when they would be available to americans. So i only have a brief amount of time he so brevity is the answer of the day. Doctor pangalos, yesterday, seemingly encouraging results from your early Clinical Trials were released. You stated that astrazeneca hopes to have the results of its phase three study this fall, and is scaling up to manufacture hundreds of millions of doses of the vaccine to be immediately Available Upon emergency use authorization on approval. Briefly, what do you think the probability of your vaccine to be proven safe and effective, and do you believe it will be available in the United States at the end of the year . Thank you, chairwoman. I think its a great question, a difficult question to answer in terms we are very encouraged by the data that we have in the phase one and to study, because were seeing both an antibody response and a t cell response, and as you know at the moment, we dont know what the union correlate protection art that will ultimately confirm protection against this virus. Right, but if it is approved, do you hope it will be available at the end of the year under an emergency basis . Yes, we would hope to have it anytime from september onward. Thank you. Doctor hoge, maduro is set to begin its phase three studied this month but has never brought a successful vaccine to market. Do you believe that your vaccine candidate will be successful and if so, do you think it will be available for distribution by the end of the year . Thank you very much for the question. I think were optimistic, cautiously optimistic i think is the word others have used, that the vaccine will be successful. The data we published in the new england journal of medicine is the basis for that, as well as other data weve seen in challenge models so, were quite encouraged by the progress. Phase three trial is a little bit beyond our control in terms of timing, because it is a case driven study, but presuming that we are able to accrue cases relatively quickly in that study, we would hope in the fall, or towards the end of the year, we would have data that we could submit to the fda for them to make a determination on whether to approve, and we will also help at that point to have millions of doses of vaccine available for deployment. Okay, mr. Young, pfizer is developing for vaccine candidates and will also begin a phase three study later this month. It expects to manufacture up to 100 million vaccine doses by the end of the year. Again, briefly, what is the likelihood that one of your candidates will be successful, and when would be available to the American Public . Thank you for your question. We are very encouraged by the early data that weve seen from our initial phase one study in terms about safety and effectiveness. We aim to complete that study this month, and summit those data to the fda and subject to their approval, within our large phase three Clinical Study and obviously that study is going to be pivotal in informing the Scientific Community and regulators, particularly, as of the safety and effectiveness of the vaccine. As i mentioned my statement, we have a line of sight and a clear, Critical Path to be able to deliver up to 100 million doses of a commercial scale vaccine product in 2020, up to 1. 3 billion doses of our vaccine in 2021. So, encouraging early signs and a lot more work still to do. Okay, doctor douoguih, how realistic is it that your timeline, based on the status of your Clinical Trials and your manufacturing capacity . Thank you for the question. We are very much encouraged by our Clinical Results preClinical Results. As i mentioned, we are starting our first Clinical Trial this month. We will be starting our phase three in september. Now, it is very difficult to say whether or not we will be lucky enough to have set up our sights in the right places to be able to get an answer and read on efficacy. That is certainly possible. But we are targeting to at least have results by early 2021, as well as 100 million doses by the end of march. Of 2021. Correct. Finally, doctor gerberding, as we learn from her testimony, mercks timeline is a little longer than the others weve heard from, but please tell us briefly, are there reasons to be optimistic that all americans who need a covid19 vaccine will have access to one by early 2021, maybe even in january . Well, i certainly hope my colleagues are successful in expected view their pipelines. I can only speak to merck, where we are expected to be in Clinical Trials imminently for both of our products but we would not expect to have a license product until 2021 of the earliest. Thank you. Thank you to all of our witnesses. I really appreciate it. The chair will now recognize the Ranking Member for five minutes for the purposes of his question. Thank you very much. I want to ask my question and i want all five we dancer in i want to make sure that you have time to answer so, mine is on the speed, and the speed versus safety and effectiveness. Doctor fauci and commissioner haaland said in testimony last month that we are not risking safety to science. I think it is the it is important American People hear from each of you on your trials so, this is the question, could you explain whether the unprecedented speed with what you are moving means sacrificing safety or efficacy, and what specifically is your company doing to ensure safety in efficacy of your vaccine, and in, that could you tell why you believe it is possible to bring a safe and effective covid19 vaccine to market when in 12 18 mark this when currently the fastest vaccine to be developed was moms, and i took four years. So when a call on, you and i will say you each have about 45 seconds to answer that but first, doctor pangalos. Thank you very much for what is a very important question so, in short, i do believe we can do this in terms of delivering but the safe and efficacious vaccine. These are unprecedented times in terms of how we interact with regulatory authorities all around the world including the fda and, also how our people work. All of our interactions, i think, have been consistent with having to demonstrate the safe and effective vaccine. I dont think any of the regulatory bodies that weve interact with our lowering their standards, and by the end of our capital studies, we will have tested on 50,000 people in that will i think be a very significant number comparable to any of the vaccines that had been approved in recent times. Thank you. Doctor douoguih, thank you for the Quick Response to you. Thank you. We do also believe it is possible to deliver a safe and effective vaccine. We have experience with the salary to programs as we develop the ebola vaccine. A lot needs to be done in parallel, but it can be done safely and without compromising any of these standards that we usually undertake for any Clinical Trial. There may be a need to perform post marketing surveillance, and were working on a plan they are to make sure leaders will be in for the duration deemed appropriate by the regulators so it will be an effort that we will continue to monitor safety long term, but it should be feasible to do this. Thank you, doctor gerberding . Thank you. You know, experience merck has a long experience task and there is a lot we dont know about this virus and there are some special safety concerns that really have to be watched for, including enhancement of the respiratory disease under this kind of immunologic pressure so i think while we are fully prepared to move as quickly as we can through the things we can do in parallel, and gearing up for manufacturing now at risk, we do not expect to be able to accelerate the safety assessment, and in fact, we are quite relieved that the fda, insisted upon applying the same High Standards of safety and efficacy, even under these emergency conditions that they would apply to any of the vaccines that we have prosecuted in the past. Thank you very much. Also, now, doctor hoge . Thank, you congressman. I echo my colleagues earlier comments. We do believe it will be possible in a safe way to bring forth a vaccine in 12 to 18 months. We have been working around the clock as an industry and as a company with colleagues outside of our company as well to make sure that we are doing this in an incredibly responsible way all the way through so, we have a full face, one, facetoface three program and as has been referenced before, were following the fdas guidance to conduct a 30,000 person full face to a program over the course of the fall. We hope that generates a robust body of data demonstrating the safety of the vaccine that can give fda and americans confidence. Thank you very much. Doctor young . Thank you for the question. Fisa was completely connected, as you heard my calls here in the panel, to ensuring the safety and effectiveness of any covid19 vaccine committed. Asked your question about how we are able to move quickly, we are actually unfortunate position where we are able to leverage a couple of years with a basic science, so we did with a lot with our partners biontech for seasonal flu and to apply those learning to our vaccine platform for covid19. I want to underscore something that my colleagues have mentioned which is, i think the American Public should take great confidence in the fdas guidance, which i think clearly in very transparently lays out standards for effectiveness and for safety. I think we are very happy to see those clear guidances and the High Standards that they are going to expect for all of our companies to demonstrate in the Clinical Trials, in order for any vaccine candidate to be approved. So, youre all saying that there will not be a vaccine on the marketplace that does not meet the High Standards of safety the and effectiveness regardless of the timing. So, thank you very, much my time is expired, that is comforting to hear. I yield back. Im going to recognize myself for five minutes next until diana comes back. Let me say that i heard what some of the previous speaker said, and historically ive been very confident in the fda, but now that trump is president i still think there is a real possibility that he will pressure the fda to lower the standards, either by maybe putting out new guidelines that say that the sanders dont have to write, now a vaccine has to be 50 effective. But let me give you a scenario where the fda changes its guidance and says, oh, it only has to be 20 effective or 10 effective, or they keep to the guidance but you know that yours is only ten or 20 effective and they approve it anyway, saying, well, it meets the standards, even though you dont. Guess im trying to rely on you is the manufacturers to kind of assume that the fda will not meet the High Standards, either by changing the standards or by saying its okay when you know it isnt. What do you do in those circumstances . I want to make sure that you will guard against any pressure that comes from the fda, either in lowered standards or to approve something that you know does not meet the standards. How can we what would you do is manufacturers to help us out in that regard, on the assumption that we cant trust the fda the way you sort of assume . And let me start with, i guess we can start with doctor pangalos. I know that is difficult to answer, but i want you to kind of assume what unfortunately should not happen which, is you know the fda is approving the drugs even though it is only ten or 20 effective. Will you tell us that . You feel an obligation to tell us that and give us that information . I will start with doctor pangalos. Thank you for a very important question. First of, all i would say all of our interactions with the regulators have given us no indication that theyve lower the sanders or thinking about it and secondly, as a company, we always think about safety and efficacy first and foremost, and making sure that we have an effective medicine, we would not be trying to produce medicine that is not effective. But doctor pangalos, what i would ask is that regardless of what the fda said this or does, that we get some sort of assurance from you and others that you would tell us the truth about the effectiveness of the vaccine, that they are now approving. Absolutely. So, all of our data in clinical studies will be published, and that is true of all the studies that we run in pivotal trials, but remember this is going to be a vaccine that is going to be used globally so, every Regulatory Authority is going to have you on the efficacy and safety of our vaccine. That is helpful. Now, let me ask dr. Douoguih, the same thing. Assuming that you find out that the fda is going to approve something that you know is not 50 effective, it is ten or 20 , can you give us some assurance that you would tell us the truth about the effectiveness of, it regardless of fda approval . I thank you to the question. So, we have a target file which outlines the minimum characteristics and desire characteristics for the development of our products and that includes assumptions of a minimum vaccine efficacy. If we saw 10 , and we would design our trial to target the embassy can see that as outlined in our target product profile, the study would fail if it hit 10 . We would make those results available, but we would not feel comfortable bringing forward a product that did not know, that was not found to be efficacious according to what we put forth in our political. I appreciate that. Now, let me ask dr. Hoge from moderna, can you briefly describe how you would report any adverse events that might arise in your Clinical Trials, once it is available for use . I try to get some answers on adverse events recorded, if you will. Sure, so, thank you for the question. Just like we have done recently in our new england journal publication, any adverse events, we would publish completely that data and we would expect to do that similarly for the phase three results, regardless of whether the trial is successful or not. It is important also to note, sir, that our vaccine study is being conducted in collaboration with the nih they have actually set up an independent data safety in monitoring board that will be adjudicating and reviewing about the safety and efficacy of our study, which hopefully provides another level of confidence in the conclusions. All right. Thank you all. I appreciate your responses and i will now yield to the Ranking Member, mr. Walden for five minutes please. If he is not there. Maybe he went to vote. I dont know. Mister chair, he did go vote. He is voting on the floor. We have another republican that is available . Mr. Griffith . Can we go to you, morgan . I recognize for five minutes. I am available, thank you very, much mister chairman. I do appreciate it. We have heard a lot of comment, and when you were answering Ranking Member guthries questions he made it clear that you all felt that the fda guidelines were sufficient. Those guidelines issued in june of this year related to the covid19 vaccine, so, lets go through that again just so we can eliminate any hypotheticals. Do you all believe, to your companies believe that the guidance issued by the fda sufficient to ensure a safe and effective vaccine, and if, not say why . I will start with you, doctor young. Thank you for the question. I would just like to reaffirm what i mentioned in my comments previously, but i think the fda should be commended for publishing a clear, transparent, evidence based guidelines that set an appropriately High Standard on both safety and effectiveness for a vaccine. I think in common with my colleagues here, i think the use of the Clinical Trial protocol that we are putting together for our phase three study will follow those guidelines. And its a vaccine or to develop low effectiveness than frankly it would fail the study, so we have great confidence that we are following the fdas guidelines, but the American Public and congress in fact should be confident that any vaccine that is approved will meet those standards for safety and effectiveness. All right. Does anyone else want to weigh in on that . I know that youve already answered the question, sort, of what i wanted to clear up any confusion. All right, may i ask this question, then . What is fda requiring of your companies to ensure that corners are not being cut during the Development Process . Are the details that you can give us that address concerns this process is happening too quickly. We can start with whoever wishes to start. Doctor gerberding . Thank you. You know, i think the way to think about this really is to understand the fda is not loosening any standard. So, business as usual, whatever portfolios or dossiers that we bring to the fda have to meet these rigorous standards. Let me just say, that when we were prosecuting our ebola vaccine portfolio, it took five years from the time that we did the phase three study until the fda finally approved our vaccine at the end of 2019, in part because they maintained a very rigorous standard of safety in the context of that outbreak so, we are familiar with the expectations and fully prepared to be transparent about any safety signals and fully transparent about the advocacy that we observe. Dr. Pangalos . I think the guidelines that the fda have issued are absolutely to their normal standards. I think if we are able to meet them we will have a safe and efficacious plan, and nothing makes me think that they have lower their standards anyway. And if mueller witnesses want to answer that question . Hi, you macaya read douoguih, yes. We also agree that the standards are appropriate and perhaps even more stringent than some of the criteria that we have for some of our other studies. We think that will ensure that we are developing appropriate studies, and with appropriate followup to really evaluate the safety in efficacy of this vaccine. Congressman, all i would add is that i think we also agree, the state is put out by the fda really on the Gold Standard and we appreciate them being put out in advance. Thank you very much. Now, i did speak with doctor young earlier about this question, but im happy to hear from others as well. Im just curious, have the companies learned anything in the process thus far of working on Covid Vaccines, that might help develop future flu vaccines and make that process both more efficient and more effective, and frankly, have a vaccine created more quickly than we know it is coming at us. Yes, thank you for the question. I think as i mentioned my earlier comments, one of the things that we were able to do so leverage some of the basic research that we had done with our partners biontech on mrna technology, which potentially lends itself to having lower and more potent dosage, but also being able to change out the coating of the mrna inner to be able to develop it much more quickly than would normally be the case, a vaccine with an engine for a particular pathogen or infection. So that will lend itself extremely well to having more effective flu vaccine in the future, and we also have a program for that going forward. I dont have enough time to get everybody in, but really quickly, can you tell the folks back home that are watching this on cspan what mrna is . Messenger arrival nucleic acid. Our bodies normally use, it it is essentially like a code that ourselves used to naturally produce protein in our body and we can use that same basic technology to release an anti jen that would enable the development of an immune response to a pathogen such as covid19. Thank, you my time is over. Thank you, mister chairman. I yield back. Thank, you mr. Griffin. Next is mr. , housekeeper nice for five minutes. Thank you mister chairman or madam chairman. I want to talk about our recent poll showed that nine and ten americans are considered the drum bakers will take advantage of the pandemic to raise prices. Insulin to other examples. Weve seen Drug Companies use monopoly control to price outpatients and sometimes make it possible for them to get their medications and ensuring the safety and efficacy of covid19 vaccines forces critical, that will mean nothing if the price is the barrier to all americans getting it. To the witnesses, the Association Firm of claimed an advertisement weve had a number of companies that have already made a public pledge that if their vaccine is ultimately successful that they will produce it, essentially at cost meeting no profit from that company, unquote. He has already stated that he will sell is vaccine for a profit. For the rest of the witnesses, will you please answer yes or no. Will you sell your vaccine at costs and provide transparency so that we can verify you arent making a profit . Doctor hogg, yes or no . We will have our is at cost. You will what . We will not sell it at cost. Will not sell it at cost. Doctor dr. Pangalos, yes or no . The agreement we have we are selling it to the government at no profit. Thank you. Dr. Gerberding, yes or no . Yes about transparency and transparency in our pricing and we have not raised our prices since the pandemic began and no, we will not be selling vaccine at cost although its premature for us because were a long way from understanding the cost basis. Dr. Douoguih. It we will be providing vaccine at a notforprofit price during the emergency pandemic. Thank you. Taxpayers have provided ten billion dollars to operation work speed but have no knowledge of how these resources are being spent. For the companies receiving tax care funding for your vaccines have any of your contracts or agreements with the federal government included provisions to ensure affordability, in pricing or vaccines affordable pricing of vaccines or treatments . Let me start again with, dr. Hoge whats in the agreements . We only have a supply agreement with u. S. Government we have a research and development agreement. Thats what im asking. , dr. Pangalos . Under our agreement its just over a billion dollars in funding which is the 30,000 page study that develops in trojan and is funding 300 that will provide a no profit. Dr. Gerberding . . We are not receiving funding from warp speed and we just have 40 Million Dollars of research and development of that vaccine and we have no agreements at all. Dr. Douoguih . Our funding covers research and development and we do not have a supply agreement in place. I will put this question out there and it may have to be answered in writing but mr. Dr. Young you have rejected taxpayer funding for your fact scene and concerned that you made this decision to be able to price couch or at least i will say that without question from congress. Well pfizer to the vaccine pricing and full transparency around research and development . Thank you for the question. Let me just say that we didnt except government funding solely because we want to do it as quickly as possible and in regards to your question, let me just say that we recognize were under extraordinary times and during the term of the pandemic, will price a potential vaccine that will help the National Emergency were facing. The Covid Vaccine should be free to the public. Its meaningless of people are unable to afford it. I want to applaud congress that many patients that have future Covid Vaccines and were committed to that aspect. Hey well see what that means when we find a cure and i yield back, thank you. Thank you miss Janice Schakowsky. Next is mr. David mckinley recognized for five minutes. Thank you mister chairman. And to the panel. What we heard today a vaccine could still be months away and parents have been saying to us that they dont want to send their children back to schools without a vaccine. Knowing what you know now, would you send your children, or grandchildren back to school . Yes or no. Each of the five. In the United Kingdom i will not be sending my children back to school. Okay. I can say for myself my wife and i are both positions and i honestly dont know the answer yet with my three children were having the fifth same challenge those other parents are having. Have you come to a conclusion . No sir. Were talking about that tonight at dinner. I dont know yet. If youre confused think about all across america. If you are following the guidelines and if its not perpetuating this problem as we follow the guidelines. How about quickly the other people. Maybe we can step up. I cannot respond to that for my perspective, i did conversation last night with a mother and two grandchildren in my family and theyre facing a situation where all three children to three children and the mother are with real policies and we need better science with daycare schools and colleges. They already said they can be back in school. They are looking for leadership on what to do with the children and given the Pediatric Association will go to the second question and after the difficulties that weve been dealing with with china. Will any of the ingredients in your vaccines come from china . Congressman mckinley thanks for the question. Pfizer and the potential number of materials and the substance will involve any part of the chinese supply chain. We anticipate for our vaccine candidate our supply chain and the pfizer will be made in the United States and the Raw Materials and the drug substance can be sourced in the case of important parts of our supply chain from canada, germany and United States. No contribution from china. This is a Global Pandemic and we want to resolve this pandemic openly and have kept our supply chains independent of each other. All of our u. S. Manufacturing has been done in the United States and around our own facilities in the United States. Let me go to the third question that i have. I was hoping it was going to be a yes or no but on this last chairman has brought up this allegation that your Companies Might bring a drug to market before it sufficiently tested. Are your companies insulted by that accusation that you can bring a drug to market thats not safe or effective, is that insulting to you . Age of the five of you, please. Thanks for the question. Given the speed at which were working people may ask questions with anyone whos cutting corners. Its the speed or working at cutting corners doesnt lower our standards. We feel comfortable in a vaccine is effective and it will be good to go in terms of the regular preapproval. Any others . We are working around the clock to accelerate our developments and were not cutting corners on safety. We believe my question was is it insulting . A company of your stature to be accused of cutting corners. We stand by our science and we will continue to develop safe and effective products as we always have. Thank you. I yield back in my time has expired. Thank you. Next the gentleman from massachusetts mr. Thank you for the conversation. Im confident about the vaccine and grateful for the work that you do. What i also want to make sure is that there is sufficient political will and corporate courage to ensure that the vaccine is not only accessible to the patients and communities hit hardest by also distributing to them as well. Because it has been the choices of elected officials and Health Care History that has led to the historic disparities wave seen throughout the course of this pandemic particularly those who have been devastated by this virus. In massachusetts, art cities have been named hotspots with covid19 with the rate of testing being lower. Chelsea, everett, more river, lawrence, lowell, when, marvel and bedford. Communities of higher rates of immigrants and minorities and color and i think theres wellknown at this point are direct correlation. Companies representing here today as enormous efforts and resources in the development of the vaccine and as Janice Schakowsky pointed out were not doing it alone. Some of them have received the backing of federal funds for support and for Johnson Johnson, and up to 1. 2 billion for afghanistan. We have a responsibility for those investors and you have a commitment to righting the wrongs and past decisions that the medicines are out of those communities and i want to start diving in a little bit here about beginning with doctor dr. Pangalos. Have you engaged at all in any plan to ensure that there is in fact a distribution of a vaccine number one and particularly at the frontline communities where weve seen rates of infection the highest . Thanks for the question. We appreciate the impact that this disease is having in communities of color and diverse cities. We will provide broad access to all races in United States and around the world. Its the agreement that we have in the United States with 300 million doses but clearly were supportive of making sure the vaccine is distributed fairly. I dont mean to be rude by just dont have a ton of time. Is there a plan thats being put forth to ensure that there is in fact have you actually developed one and what stated element is that . Its the administration that have the doses we provided. They distribute them across the United States and throughout the United States government. Same circumstance . Its up the administration to decide distribution . It is. However, were willing to share our plan that were working on which adds to the framework of the highest medical need and will have further discussions on that important topic. Dr. Gerberding, do you have a plan or not . Dr. Gerberding . Yes. Thank you. We dont have a plan right now because we dont have a product. I just want to say very quickly, the acip and the modern medicine that will adjudicate those allegations and the administration per se. Dr. Hoge . Congressman, we agreed the vaccine is in the place the most need and support that and we will rely also on the government to distribute the vaccine. Doctor young . Thank you for the question. Like my colleagues, we believe in ensuring its approved to the patients of greatest need and we believe the cdc guideline develop the number of years ago that those will be a greatest risk. We look forward to working with the administration with distribution. Just over clear and i have a few minutes left on this. Im not talking about government funding with the most resources, all of you are relying on a government that couldnt provide ppe especially now to places across this country and weve got even with those dollars and from the environment were still 26 of people that rely on insulin and still cant get access to. Its great youre saying youre distributing and clearly the federal government has failed here times over. Im just curious, if you dont think there will be a problem for companies when communities of color and minorities dont have access to this you will come back here and will have another hearing. By or beware on this if you dont actually make some effort potentially now. I would urge you to do so because the consequence of not doing this right is going to be dramatic for this country and this administration i dont trust at all to actually do this right and i yield back. Chair now recognizes mr. Mullin for five minutes. I dont think at all our government has failed. For a pandemic we never experienced before were responding better than any other country out there. Were testing more, developing more and theyre depending on our country to find the vaccine. To say our government failed is completely wrong. Real quick, can each of you speak to your manufacturing capacity and how ramping up to meet that demand would be needed once the vaccine is authorized by the fda and i dont really care the order you can do it one of the time. Thank you for your question. As i mentioned in my opening, we have a dedicated supply chain with supply through the United States and were working with our partners to develop a supply chain and will have the luxury leverage in our sights and handover in massachusetts and michigan with our stop manufacturing process. Were very proud of the work that our other colleagues have done. They work already before we have our phase three program to establish our manufacturing supply. We still have a lot of work to do and were excited about what our colleagues have gone so far. Thank you. Let me go next. Im confident about our supply chain and our operations deem of done of phenomenal job and the cities have been working with our partners in mri and we have 100 million doses in the first half of next year and will continue to supply as it needed and as it safe. Thank you. Ill take a stab next. Weve been working on a dedicated u. S. Supply chain for several years now, we go to the factory in massachusetts to manufacture and recently partnered with one of the largest manufacturers of drugs in a Company Called logs a in new hampshire. Their supply chain is confident will have several million hundred doses next year. Like the other manufacturers, where manufacturing at risk meaning were preparing now and we expect to have hundreds of millions of doses available beginning in 2021. Are securing the supplies that we need to be able to support that. Thank you. I can answer for johnson and johnson. Were setting up Global Supply. We have entered partnerships with emergent and cattle noon so well have at least 400 million doses from those facilities and were setting up other areas so we can supply the rest of the world with a vaccine. Were targeting 100 million doses by early 2021 with the goal of getting to one billion by the end of the year. Thank you. Can you guys tell me if any of this manufacturing as been done in china . It is not. It is not with johnson and johnson. Only the u. S. Supply chain. The majority or all of this is happening inside the u. S. . For pfizer 100 . It will be supplied from our u. S. Based supply chain. The same for everybody else . Yes. We have supply agreements around the world and the supply chain will be sourced in the u. S. And other supply chains around the world will be supplied from other sources that are dependent and not competing with each other. Merck committed our supply chain in the u. S. Of about 9 Million Dollars prior to the pandemic and were only adding to that now. Great. Johnson johnson, half of the supply will come out of the u. S. And the rest will come from other supply chains distributed around the world. With 20 seconds left, real quick. Does the majority are all of you guys look to expand your manufacturing . Yes. Yes. Yes. Thank you guys. Madam chair, thank you so much and i yield back. Thank you very much. Chair now recognizes raul ruiz for five minutes. Thank you all for being here today. Im cautiously optimistic that the progress you are making in your efforts to develop a safe exit scene. While the numbers of the vaccine that you anticipated in the next year seem promising, im very concerned about the lack of Health Equity plan in the distribution of those vaccines. The double what steps is the sides of developing and effective it safe accede. Number two step is to produce that vaccine. Number three is to distribute the vaccine and then for is to administer the vaccine in the front lines. We should be able to foresee whats coming and develop a Distribution Plan that based on Public Health principles with the objectives to slow the trend of transmission and to save as many lives as possible. When we ask those questions then we need to ask the questions where is the highest risk and the highest rate of transmission of coronavirus, which communities and demographics are dying at a higher disproportionate rate of coronavirus. It is not too difficult to find the answers to those questions. We know that seniors and seniors in Nursing Homes are at highest risk of dying those with underlying conditions. We know african americans, latinos, native americans are at the highest risk of getting infected in also dying from coronavirus. We need Public Health principles based on Public Health and equity, not politics, not for profit going to those who are the highest bidders or objectives that favor the powerful, the prosperous or the healthy. For large corporations who can afford and offer the highest bidding amount in order to keep their healthy workers safe to affect their bottom line in the profit. We cannot repeat what has happened already in the distribution of testing in the outreach and in the treatments of the coronavirus. I was just called by a previous employee yesterday who told me or texted, his sister works in the front lines of covid19 units was recently exposed and couldnt get tested herself and wasnt offered and wasnt offered in a hospital. She had to go to an urgent care and pay for it herself and it was difficult to get testing. Yet, he has a cousin who is in training for the professional Baseball Team and they get tested every two days. My office is hearing the same thing from nurses across my district. This is unconscionable, we cannot repeat this mistake with the distribution of vaccine. Having millions of vaccines is a good first step. We also need to be planning now how we get the vaccines into the hands of people that need it most. I dont want to look back and then have Health Equity being an afterthought, it has to be prioritized. I want to ask dr. Gerberding from merck, what is your company doing to ensure that the distribution of these vaccines are getting to the populations that need them the most with the highest transmission and death rate from covid19 . I think the best way to answer your question is to think through what works and doesnt work in this regard. Its the cdcs responsibility and the acip that makes decisions about allocation and in this very special case i have personally and maybe all of us through the county medicine to create Health Equity and ensure that the allocation is fair. Thank you very much. I heard a lot about thats the government, thats the government but not all of you are going to give 100 percent of your vaccines to the government. There will be a percentage that you will hold back for the private market as well. That market should also follow a Public Health principal so we could save as many lives and we could stop the surge in order to improve the Public Health. Dr. Young from pfizer can you answer that question for me, please . Very forward question. I wanna support what my colleague dr. Gerberding has said. The cdc has laid out very clear criteria for pandemics situations and patients should be prioritized. We are looking to network with the federal government in order to ensure that its essential. Alaska every single one of you if you can please mail my office and this committee your distribution priorities. Not only that go towards the government but also that you have within your private market, sales and distribution and what your objectives are during this pandemic, can you do that, please . Yes we will. Yes. Thank you. Dr. Pangalos, dr. Hoge and dr. Gerberding, can you do that . Yes. Ill take that at the us from all of you and ill follow up with you as well and ive heard from Johnson Johnson, thank you. Chair now recognizes the Ranking Member greg walden for five minutes. We talked before this and i have a couple of questions first of all, real quickly when we talk about the testing thats available before the end of the year and next year, to all of your vaccine candidates require at least two doses to be effective . John young from pfizer. The protocol we will study in our trial will use an additional dose so yes to doses. Is that true for the others of our witnesses . It remains to be seen. Go on. I was going to say or earlier in our development and we may have the possibility to evaluate both but we dont yet know. All right. Merck selected vaccine candidates that have a reasonable possibility to have a single dose a vaccine as our whole but thats not proven at this point in time. I would suggest that they are getting a stronger immune response and understand the protection and that one will be enough. It could end up becoming one of those. Thank you. Thats really helpful for the public to understand. When we talk about having 300 million doses we probably should estimate thats cut that in half in terms of people that will get vaccinated and thats worstcase scenario my takeaway of that. In terms of the supplies you need and many of you talked about this. The ancillary supplies just says stoppers and packaging and shipping. Is the federal government assisting your companies in this endeavor or do you feel like you have the supply chain lock down a to be able to produce package, ship safe and effectively and efficiently and with the administration or what in congress we need to do to assist to that . Obviously, the funding are getting from the government, which were very thankful for, is helping us ensure that we have everything we need to enable the supply of the 300 million doses rapidly as possible, so, from our perspective, we have what we need, we think, and supplier has agreed with the government. Doctor gerberding . When we say we are anticipating hundreds of millions of doses going forward, we have secured the necessary supply contracts, etc, and we can do that because we are big company we make a lot of vaccines so we have existing relationships for those procurements. Others . Here we are working on a Global Supply chain to be able to provide what is needed to. Are you confident will be able to achieve that . So, far looks it that will be the case, yes, but we are monitoring situation closely, and we would appreciate the support of thats available. It had very positive engagement with our suppliers, both for Raw Materials but also for glass and so we believe we have a path to be able to have all the necessary materials for a Vaccine Program to be successful. Hes a doctor hoge . We believe we have a path where we have secured officers supplies or are in the process of doing that but we do appreciate that folks at b. A. R. D. A. And hhs has been helpful in helping us identify contingency plans. I want to talk about fda for a bit, just real quickly, are you welcomed with the guidance fda has issued to protect consumers safety and ensure the efficacy of the drug . Is there anything there that disturbs you . Are you this is are you concerned that someones gonna try and rescue into production . John young from pfizer. I would really commend the fda revving been extremely productive and very transparent by the criteria that they have laid out for about safety and effectiveness. I think those standards are high, and it should give all americans a lot of confidence that actually if a vaccine is approved, under a ble or under emergency authorization, but theyve done so according to stringent guidelines for which they are to be commended for martin. My time is running out. Does anybody disagree with that . I completely agree. Thank you all, and the team you worked with for the work youre doing to try and safeguard the world, frankly, from this pandemic, and bring about a vaccine and therapeutics and madam chair, i yield back my time. I thank the gentleman. The chair now recognizes miss castor for five minutes. Thank you very much, madam chair, and thank you to all of you for being with us. One point i want to make clear, because we know were talking about confidence of consumers and americans who have a great deal of stress and anxiety, could you articulate, briefly if you can, the notion that because you are taking a risk on the manufacturing, that is related to speeding up the timeline of the vaccine, but that you are not taking a risk as to the safety and efficacy on the research side. One if you could, one by one, and we will just start with doctor pangalos. Yes, this is a very good question, congresswoman. So, youre absolutely right. Whats different about what were doing is that we are manufacturing in the hope that we will have a safe and efficacious vaccine, but that when we have that data available, and the hope that the regulators agree that vaccines are safe and effective, we will have the dos and supply in the u. S. And around the world straightaway. That is what i think this funding from b. A. R. D. A. Gives us. And how much time do you think that takes off the clock of a typical vaccine production . Its difficult to quantify, but a lot. I mean, you would not be making these investments and these clinical studies, before you have any evidence of efficacy, so i think it is a huge help. Thank you. I want to focus in on the daunting task of ramping up production to provide doses for over 320 million americans in a matter of months. This would be an unprecedented task and our Ranking Member has pointed out that this may take two doses per person. Recently i introduced hr 7104 which would expand our manufacturing capacity and require the administration to begin this planning now because i believe planning is essential so that we can assure that all americans have equitable access to the vaccine when one is available, and our communities can reopen fully and safely, including our schools. This legislation was included in the house version of the heroes act, and im very anxious for the senate to move forward without delay. So, again, doctor pangalos, if you will, astrazeneca has stated it anticipates producing 300 million doses of the vaccine, beginning as early as this fall. Does that include the one billion doses it plans to supply around the globe . It does not. Theres 300 million does a far u. S. Supply chain only. The other 1. 7 billion doses plus that we will be supplying around the world will be done in indian supply independence apply chains around the world. Thank you. And mr. Young, pfizer anticipates producing up to 100 million doses by the end of 2020, and 1. 3 globally in 2021. It is my understanding that fisa recently had some challenges challenges in manufacturing sterile injectables that resulted in shortages and delays. What steps is pfizer taking to increase its capacity, and mitigate any risk and future shortages or equitable distribution issues . Thank you for the question. So, since we acquired another company in 2017 we have invested several hundred Million Dollars in order to remediate production difficulties and some quality challenges. We are very proud of the work that our Manufacturing Team have done, and indeed were particularly proud that in the covid19 pandemic, actually, those sites have been able to respond to incredible increases in a number of really important basic injectable medicine to be used in intensive care situations and obviously we saw that with covid19 so, our plan was that would be substantially remediated 2019 and completed by 2020, and im pleased to say that those sites were on track. The sites that were supposed to manufacture the covid19 vaccine are actually from our legacy pfizer network where we dont have any history of compliance or quality problems. All right. My time is coming to a close. I will do my next question for the record, so thank, you and i yield back, madam chair. I think the gentlelady. Chair now recognizes mr. Burr just for five minutes. I think the chair. Madam chair, let me be frank, i asked him to play some of the record with a rather for Retractable Technologies from about production for 240 million syringe is, contract they recently received from b. A. R. D. A. Both. It is significant, with us being able to provide the delivery mechanisms, that i would like to ask all of the panelists, along the lines of what doctor ruiz was discussing about the availability, you know, the price of vaccines historically has not really been one of the big obstacles, or a big determinant in vaccination levels. In fact, weve had some hearings in this investigation subcommittee on the issue a Vaccine Hesitancy. It introduced a bill with director shriver in Washington State following a Measles Outbreak there last years nose and this was a bill designed to increase or decrease Vaccine Hesitancy phillips was. So just call on our, panel are there additional steps of the administration and Order Congress could and should take to encourage the American Public to receive the vaccine when it is available . And why dont we start with astrazeneca . Thank you. Congress member just, and its an important question because ultimately we know that people need to be vaccinated to be protected from the pathogen and we recognize that vaccine as a messy and public mistrust in the covid19 vaccine, given the dispute which we are developing, it may be perceived as a problem . We are supportive of the u. S. Federal agencies to support that a vaccine can be available safely and effectively, and i think the fda commissioner has already committed to showing that the fdas review process, when we got the higher standard. Weve talked about those at length, and of course we all support the cdcs efforts to encourage people to be immunize, particularly in areas and communities that are i mean under immunized. Thank you. I think we actually identified as a weak point in the hearing we did a year ago but i agree, we are going to have to engage with cdc. Johnson and johnson . From the same question to you. Well, grieve i fully agree that Vaccine Hesitancy is an increasingly bigger challenge overtime, and it certainly will be for covid19, i think the average of discussions and educational materials, all of that needs to happen now. And we would very much support any efforts that really focused on solid Educational Programs to make sure people understand, and share their concerns, because its not only about, access its about people willing to accept a vaccine and having confidence not only in the safety in efficacy but also have their concerns answered. Great. Doctor gerberding . Thank you, i could not worry about this more. I think that trust as a consequence by the truth telling as well as transparency and is not enough to have a government spokesperson, we really need to engage the people that are trusted, and often those are doctors at the local level, so we do have to engage the medical community, and have people get the information, and then have their own confidence or what were doing, right . They can translate that at the community level. Right, doctor hoge. Thank you for the question. I couldnt agree more of the concern, just like the other panelists. For you think its gonna take a broad effort to make sure the vaccine is properly adopted i would echo as well doctor governings last comment, there is a trust deficit, i would have to rely on those who have that trust, particularly given the short time horizons we have. Great, and after young . Thats the question, i think Vaccine Hesitancy is probably one of the greatest challenges for Public Health in america. We fully support the work of the cdc and i endorsed the comments of my fellow panelists, that actually all of us need to play a role in ensuring that should be successful in this mission, that actually there is confidence in the safety and effectiveness of a vaccine, based on the confidence that the fda will approve vaccine, only if it is proven to be safe and effective, and we certainly support the work of this panel in achieving that end. Thank you. Federal govern has lost several initiative and you accelerating medical countermeasures, including vaccines. How is your interaction with the federal government being through the Vaccine Development process . Have they been helpful . Yes or no . Thats again start with astrazeneca. Yes, theyve been helpful. Thank you very much for their support trump. And, yes Johnson Johnson . Yes, theyve been extremely helpful very constructive in this process. And dr. Gerberding . Absolutely helpful. We would not have an ebola vaccine approved in license if it was not for b. A. R. D. A. Him. Doctor hoge . Yes, absolutely. Incredibly helpful. And mr. Young . Yes, we maintain very constructive discussions with our whole range of federal Government Agencies. Thank, you madam chair. I yield back. The chair now recognizes ms. Castor for five minutes. Well, thank you, madam chair. Thank you know our witnesses to more here today. I would like to continue the discussion about cdc and our Public Health professionals across the country and how we will distribute vaccines because i believe any success, and a successful effort to deploy the covid19 vaccine we will rely on our Public Health professionals across the country. They have been on the front lines of the pandemic from day one. Weve got to build on that longstanding Public Health infrastructure thats already in place across america and while i believe its been drastically underfunded in past years, the congress has provided some resources to cdc and our Public Health departments, and here is actually passed in the house months ago would build on that investment. In the state and local immunization leaders recently wrote to operation warp speed meters just a couple of weeks ago and they said our nation has a decades long track record of facilitating both public and private infrastructure to successfully deliver lifesaving vaccines. Them very concerned, because the Trump Administration has not relied on our Public Health experts and at times when we need their guidance the most, and i think this is their dismissal of scientists and Public Health experts has really put folks at risk. I represent the state of florida and we are in a world of hurt right now. In fact, just this past weekend it was reported that the Trump Administration is trying to block necessary funding for testing, tracing, and the cdc to fight covid in the next emergency aid package so, getting a vaccine that is safe and effective is going to be absolutely critical, and i hope that the president and those around him will consult our Public Health professionals. Doctor gerberding, you are in the cdc. You are a leader there. In your testimony, you state, we urge strengthening of the systems that support routine immunization systems and preparing now to adapt them to mobilize for mass vaccination programs once the pandemic vaccines are available. Would you agree that the centers for Disease Control and the longstanding Public Health professionals across the country have been critical to our nations historical Vaccine Distribution effort, and what role do you believe the cdc and our Public Health partners must play in a national covid19 vaccine plan . Thank you so much for your questions. inaudible im getting some, echo i hope you can hear me. Doctor getting in our commuters and our, adults we cannot possibly do this without the cdc and the front line of our state and local health departments. We need to strengthen their support. We need to strengthen their ranks, and we need to get fully behind them, among them not only with information but with resources necessary to step forward and support Mass Vaccination Campaign in the context of this pandemic. They are our frontline through people in the. That whole system has been very successful in the past to contain outbreaks, i, mean for h1n1, we delivered over 100 million vaccine doses during that 2009 pandemic. Mr. Young, why will this existing that scene Distribution Network and infrastructure be essential for the covid19 Vaccine Distribution . Thank you for the question. So, i endorsed everything doctor gerberding has said. Plainly, the challenge that we face is enormous. In theory, i think doctor gerberding in her testimony, she already said, none of us are safe until all of us are safe, and that is what is unique again about the situation and the points for vaccine. Ultimately, everybody is protected, and so the critic already of the Public Private partnership that is represented in this hearing today, actually the engagement of the Government Agencies and distributing networks to be able to get to potentially 330 million americans and ensure that theyre all protected, is going to be absolutely fundamental. And doctor hoge, is this coordination happening now . Leaders to your knowledge is the operation warp speed leadership engaged in this kind of planning with our Public Health professionals across the country . So, i cant speak to what operations are doing outside of our division, but i am aware through our conversations they brought in colleagues obviously from the nih and cdc and other Public Health officials to help us both plan how to execute our steady and perhaps to begin to anticipate what happens if we end up with a safe and effective vaccine. Thank you, i yield back. I thank the gentleman. The chair now recognizes mr. Duncan for five minutes. Thank, you madam chair. And i want to thank the witnesses for being here. Some stats in South Carolina for our population of 5,148,714 people, we have had 1164 deaths. That is a 0. 23 mortality rate in South Carolina, 89 recovery rate for folks that have contracted covid and have gone on to recover. I am glad we are pursuing this vaccine, but i just want to caution us to a few things. When i look up the data for an influenza vaccine, and granted, there are many different strains of influenza, but there is also a fear that covid19 could mutate, and have different strains, but when i look at something weve been dealing with a long time, and that is influenza, we have to guess every year what strain will be there. If you look at the effectiveness, in 2019, it had an estimated 45 effectiveness. In 2018, a 29 effectiveness. 2017, it was 38 . 2016, it was 40 . 2015 was 48. 2014 was 19 effective. For a vaccine that was created to deal with influenza, and a virus that weve been dealing with a long time. Now weve got a novel coronavirus, known as covid19, and were trying to create a vaccine for it. Hopefully it wont mutate. Hopefully the vaccine will work, but when i think about influenza, i think about the fact that it affects a very similar population, more so than others, and that population being the older population, 60 plus, especially if there is comorbidities involved. Influenza affects the same age group. When you look at the data of influenza, he uses a comparison, the vaccinations are effective, most higher percentage wise, and healthy adults, age 18 to 46. Thats about a 70 effective rate. Healthy children aged six to 24 months, 60 60 6 effective rate. Influenza vaccine can also protect against other infractions, with the benefit of 15 to 45 . Where it is not effective is that population 60 and above, especially when comorbidities are involved so, lets shift to covid19. Were trying to create a vaccine for covid19 and my question for every company is, how would you create a vaccine that is effective for the most vulnerable population, and that is the 60 plus population, especially when there is comorbidities, comparing to the influenza vaccines which is not very effective for that demographic as well so, how are you going to target the most vulnerable population, if you look at the fatalities of covid19 from the. And so that was . And how you can deliver those, that is another question, but lets talk about how youre going to target that vulnerable population. Thank you. Its a really important question, and i think at the very back the beginning of Vaccine Development, tend to study vaccines and people have the greatest likelihood of responding to the vaccine but we do need to understand what will happen with these vaccines and older people. That is one of the reasons why i think were going to ultimately end up with more than one vaccine. The first vaccine might not be the best vaccine for seniors or four children so, we need to have additional studies to really define the value in the highest risk populations, and the safety in those populations. Okay. Mr. Pangalos . It is very important question, and during our studies, we will treating a variety of age groups, from five years old to 70 plus and so we will be able to generate who gives us an indication of who is likely to respond to a vaccine, and previously the regulators have said they want to see a 50 efficacy level in the broadest population, but it may be the younger population response better than an older population. We dont know yet, but we what we do know with our vaccine, is that we do see immune response in the elderly so, we are optimistic that it will work, but we also have additional therapies, like our antibody programs, which will be generating a romine and immune response, so if you have an immune compromised individual, we will be able to treat them with an antibody instead, and we will be helping them basically giving their immune response. My time is about a. Lets go to macaya. We, i fully share your perspective and said the elderly are an important population and that is why we are playing to evaluate them in our very first study so we can understand what the immune responses are, what does the safety profile look, like and what the appropriate doses and our schedule, such that we can evaluate them in our efficacy as evaluate our efficacy and our study as well because we believe there should be some of the first people to get access to the vaccine. We do have experience with our platform. We have a Program Targeting the elderly, and we are encouraged by some of the data that we have now been seeing in terms of the immune response looking terrible compared to what we see an adult. So it is possible we will have a viable vaccine for that population. Therefore the question. It is an important question, two quick answers because we are running out of time. Weve already evaluated our vaccine, and that date is going both in the face wanted to study that we look to publish in the future and in our face three study weve actually stratified the study for 20 25 of folks who are over 65 have comorbidities. Specifically to evaluate response to the magazine in those populations. Mr. Sarbanes is recognized for five minutes. Thank, you madam chair. Can you hear me . Yes. Excellent. I want to thank the panel for all your work, and obviously for your testimony today. I want to drill down a little bit more on this tension between safety and speed that youve spoken about a number of times. Of course, all of you have testified that you dont have to sacrifice safety to achieve the speed that you have undertaken right now but it sort of begs the question, what happens in normal times . Because i know for example that you wouldve said to investors that were leaning on you are quickly with getting a vaccine produced over some other product that you have to go deliberately for safety reasons so, maybe doctor gerberding and dr. Young, just to take two of you from the panel, tell me exactly why it is that we are able to move fast without sacrificing safety when we lay that against what the normal procedures would be, that you are now putting staff on this literally 24 hours a day, whereas normally youd be working a 12 hour shift . Isnt that youve got 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 fast but stay say. If i can start. You mentioned some of the categories. I think the biggest time saver is the fact that we are already investing in building the manufacturing capacity, literally, the plants that will be manufacturing the vaccine because as we said earlier, normally, that does not happen until we have proven that the vaccine works, so that takes a huge chunk of time this. It but in addition, the collaborative efforts such as the nih is creating, bringing together Industry Leaders along with scientists are trying to define what are the leading candidates so we dont waste time and resources prosecuting a portfolio that is not going to go anywhere, to concentrate on the most promising opportunities. And i think the fda is doing a lot to ensure that the portfolios are reviewed in an expeditious manner, even putting the guidelines out is a great help to us because it creates more regulatory certainty about what we need to come forward with a portfolio. We know we need six months of safety data, for example. So all of these things adding together begin to chunk out pieces of the normal, very extended timeline. That all axioms things will go exactly as you plan. I think those of us who are experienced vaccines know that is not always the case and so we dont want over promise in the timeline. That is one of the reasons we are cautious about that. Let me jump in and ask another question, and pivotal little bit here, but its related. Let me say, related to the point that you, made i think you are describing how this pandemic may be completely changing up the way vaccines are produced and approved and tested and so forth, for life after the pandemic. Hes obviously, this is an unprecedented situation, but it is forcing a changing in modeling of design in how we do this which will be relevant on the other side of it, and i think its interesting in the moment to step back and consider what that means, but, let me pick up on your point about expanding the manufacturing capacity, in a, sense ahead of whether you know that youre going to need it because that is going to be a time saver, and i know that a pfizer executive recently indicated that even if the companys vaccine is not successful, pfizer will pivot and dedicate whatever capacity it is building to help reduce what is successful so, maybe from doctor douoguih and doctor pangalos personal, you can speak about weather Johnson Johnson and astrazeneca have a similar posture, on whether youre going to step up and part of the manufacturing capacity solution regardless of what happens with your own vaccine pursuit. Thats a very good question and i think we can make ourselves available for those types of discussion, if our vaccine were not to be successful, we would have the capabilities to produce, it is something we would maintain a discussion, on absolutely. Doctor pangalos . I can say weve been having conversations with the administration about our overall manufacturing capacity, they were already 100 full, which is why we are using contract manufacturers to actually help us provide 300 million doses. Thank you. I yield back. I thank the gentleman. The chair now recognizes ms. Brooks for five minutes. Thank, you madam chairwoman, and thank you for holding this incredibly important poll here, and 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 very much for your work. Doctor birx already brought up the fact that this committee has brought the issue a Vaccine Hesitancy and Vaccine Confidence, and a recent poll shows fewest 50 of people in the United States are committed to receiving one of your vaccines, with the other quarter wavering, and so i continue to be really concerned about what we all are doing relative to Vaccine Hesitancy and so, im really curious what your specific companies approaches are, whether it is how you marketed, how you communicate it, how you educate the doctors and the Public Health professionals about the efficacy and safety of your vaccine because as you can see there has been a lot of questions about that and i will start with my friend and fellow chair with the csis commission, doctor gerberding, if you can share with us what mark is doing, i know you talked about truth telling and so forth but what is that companies are doing specifically to help educate the American People . And i would love to hear from everyone, doctor gerberding . Thank, you and thank you for mentioning the commission, we really appreciate your support in that regard and in all of your efforts on behalf of our Health Security. You, know its a long answer, and i should bring some of this back to you for the record, but the short answer is really that it really does have to do with grassroots as much as it does that top down and that means getting out in the community. For example, dealing with the Health Disparities of covid means we go to the front line. We are going to various local ngos, the opportunities to bring information to people, to encourage them to seek care, to try to catch up with the mist faction a shuns that have occurred in the consequence of the pandemic. So far, we are now at risk for a measles pandemic because of wondering mean is a shun. So, it is the grassroots, on the ground, supporting the medical providers and supporting Community Leaders on their terms, bringing them information. As chief patient officer ive round tables with various Patient Advocacy groups listening to what they, noaa weather concerns, are and how we can broker better information exchange. And then of course social media is also a big help. Astrazeneca, anything different . I would just add, i think the other piece that we need to be doing is being incredibly transparent about the data were generating with the vaccines and the studies were running. For two years postvaccination, we making sure that data is visible for all of the different Ethnic Diversity is in our trial populations, different age groups, i think we will give more confidence the population at large in the vaccine is safe as well as effective. Thank you. Doctor douoguih . Yes, i think the adverse need to start now in terms of education and outreach. Of course, we have to develop a safe and efficacious vaccine and be confident that the data we are presenting our sheridan understandable or they just go away so that people feel comfortable in accepting vaccination. But i do think the communities that are disproportionately affected might require more engagement and that is a long process, and that needs to start now so they can consider participating in Clinical Trials, that diverse participation also gives credibility to with the safety and the efficacy of the vaccine, and forms the foundation for the work that has to come after that. Thank you. Doctor hug. I want to make sure everyone is able to see what your company is doing. I would echo the comment about transparency in the data were working to generate. We needed to create information that elasticity visor to make recommendations to patients and of course our focus right now is making sure we are growing populations in our face three study, that are representing the burden of disease and we are part hearing with never different, roofs at the National Black church and also the nih and others to return to those committees, to leverage those trusted advisers to communicate with those populations. Its a critical question, i would endorse what my fellow panelists have said. You data transparency is really important, one of the commitments that we made early on in this pandemic is to publish transparency transparently or Clinical Data as we generate, at which we have sought to do. Like some of our other companies here, we are also looking to ensure that our pivotal study is representative of the burden of disease for covid19. So recruitment minorities, of women, of older patients in those studies, going to be really important. And that trial is complete. So physicians, the Scientific Community, and then the grassroots of america, confident that a vaccine is approved, it is going to be safe and effective for patients. I would remind you, what most of us are not the or in the medical community and so the extent you can educate us all in the best language possible is most appreciated thank you all for your work. And good luck. I yield back. Thank you to the gentlelady and the chair now recognizes mr. Peters for five minutes. Thank, you madam chair, and thanks to the witnesses for being here. I am sort of at the end so i have a long list of questions, most of them have been answered. I want to say thank you very much for the good work that you are doing developing this vaccine and of course we wish you the best of luck. A couple of things i didnt hear that i want to ask about or about interactions with the flu vaccine. Will patients, in the ordinary course, be able to get this vaccine at the same time as the flu vaccine, and when will we know if there is dangerous interactions between the vaccine and other medications. . I think during the course of our clinical studies around the world, we will be looking at all of the appropriate drug interactions, interactions and comorbidities, etc, that you would need with any regulatory filing and you need to be aware that obviously the regulators would look at that, i think that would be during the clinical studies that we are running. Youve spoken at length about the elderly his, and i guess the question i had is weather for young kids are going to be able to get or use this vaccine. Are you testing that vulnerable population as well as the older folks as part of the phase three trial . I can confirm again we have a pediatric study that will be ongoing in the United States, in addition to the border population. Here we. Here we are playing to initiate our pediatric program. The vaccine is available later for those populations than for other folks, would that affect the schedule at all . We dont need to understand what the schedule is and the immune response but you dont necessarily need an efficacy study in that population to be able to just generate the appropriate safety enemy response data. One of the issues come up as a result of our country not being prepared for this, is the availability of the Onshore Materials we need. Obviously, the big topic of conversation, ventilators. But i want to ask about basic pharma. A lot of basic farmers that has not been available has already become generics, its not the one that youre involved within the United States, in terms of domestic production, most of that is produced overseas in india. Can i ask each of you for your thoughts on how the United States should strategize around making sure that those drugs, those pharmaceuticals, are available on shore when we need them in case of a second wave or the next pandemic . Maybe start with mr. Young . Thank you for your question. I think the question of availability of high quality essential medicines is a critical one for every Health Care System around the world and that is something we have tried to play our part in and are very committed to. I mentioned earlier in response to a previous question that actually how manufacturing that work in the United States has seen a significant surge, and a number of those injectable medicines their off path, and they are basic, but absolutely vital to essential care, particularly in intensive care situation. We have seen specks of ten or 15 fold for some of those medicines, given what weve seen in intensive care units. We believe that is absolutely critical and certainly we are committed to our safety and supply network. We have sites in the United States 12 of them. That is something we are very committed to, in trying to run out the spirit of your question. Yes, the representative from johnson, johnson maybe more specifically, how would you suggest that as a committee and as a congress we strategist get those basic drugs, many of which are generic, onshore for the next pandemic . Im not sure im the best place to answer that. My focus is indeed on vaccines. What i can say is that we are committed to providing our product to making sure that the people who are already on these medications have access to those first and foremost and those who are at risk are next in line for that, and so far we are monitoring our supply and making sure we are able to continue to provide the pharmaceuticals that we have marketed. Thank you. It is probably a topic to future hearings. I appreciate your thoughts. When im, sure i yield back. Thank you. Some, seeing the subcommittee at this time were not in the. Thank you to members or not of the subcommittee, and thank you for joining us and i will start with congressman upton, if youre ready, for five minutes. Like you. Thank. You it is like to be here. Thank you very opportunities hearing. Then you put your camera on, please . I thought i had it. There. It should be, on right . No. There you go, we see you. There we go, okay, good well, thank you, really appreciate the opportunity for the hearing and9ann thank our witnesses for coming today, certainly to discuss all but theyre doing to quickly develop a safe and effective vaccine and i want to especially thank john young the, and of course, earlier this week we got the great news that two vaccine candidates. We got past as a nation with the fda, after last week, thursday, i had the chance to visit prizes manufacturing facility in my district where they are in fact already gearing up to make their vaccine. Its amazing how quickly youve been able to mobilize on something so huge in a short period of time, and as i talk to folks there, they had received a message from the higher up, to spend whatever it takes to get this done. Just a quick question for doctor young. You take us through the whole manufacturing process, and in particular, i know you referenced this in your testimony, the idea that we would have the supply chain in essence done, made in america, from start to finish, at least for the first 40 million doses that youre planning to produce there, and assemble their, before the end of the year. Can you just walk us through that manufacturing stage . Thank you for your question. We are extremely proud at the rule of our columbus you facility in your district is doing in the manufacture of our covid19 vaccine so, the manufacturing supply chain for an mrna vaccine is quite unique. The three sides that we have in the United States, that before mary died supply chain, each have a distinct role to play. So our site in st. Louis, so one side will create a dna template, a template for the messengers, which is the protein that we hope we will set an immune response, ultimately. That dna template is then passed to our site in and over where it is used to create the mri nay, and that is combined with litany no particles so you have a very small piece of mri nay insight that is literally microscopic droplets that have specifically been designed to be taken up by the bodies cells. And then that substance taking the columbus you in michigan where it will be put into the vials of health care professionals. And that drug products will then be taken into the supply chain and enable it to be distributed to hospitals and clinics all around the United States of america so, we are very proud of the work thats been done today, and from the comments my fellow colleagues, i know we have a hard a lot of hard work still ahead of us, but thank you very much for the question. Just a quick question. I want to ask something now. So, i know that the next trial is going to start literally in the next week. 30,000 american participating in that trial. What is the earliest that you might, assuming everything goes well and its not a glitch, and if the Safety Standards remain the same, when is it, the earliest that you think that you might be able to see an easy way, an emergency use authorization that would then allow the unleashing of the producing of tens of millions of vaccines to the American Public. Thank you for your question. So, if all goes well, we hope to be able to provide our dossier of Clinical Data from our large phase study to the fda in october. Obviously the fda will then review that and they will determine whether we meet the requirements but they have already laid out for what would determine the authorization so they will not be able to review that data for our vaccines but potentially other vaccines represented here. So potentially they would have the data to go on to make that decision by the end of this year and that is why we have invested in our supply chain, in order to be able to deliver up to 100 million doses of vaccine in 2020 globally and up to 1. 3 billion doses in 2021. Ill thank you. With the remaining, time let me just say this, the chair of the subcommittee, the two leaders, comey on passing 24 century curves through the congress. You tell me, how helpful this was, as it leads your actual production now of the vaccine. Thank you. And again, we support the work that you are getting done at 24 century cures, we noticed the funding mechanism for the fda helpfully the groundwork for many for instance, the recent pilot program, that Clinical Trial designs, the fdas familiarity with real world evidence have all been underpinned by some of the measures that we at 21st century that 21st century cures helped wet and i think we should begin to build upon 21st century cures and these advancements as the committee begins to constantly secure so, thank you very much to this committee for your support and thank you for your leadership. Thank you. I yield back the balance of my time. Hi. Next we have congresswoman as you for five minutes. Thank, you mister chairman. I would like to thank all the witnesses. I have listened highly attentively with the exception of going over to the capital to vote, so, thank you for your work, and the speaker of the house, says on a regular basis that science is, will be, and is the answer to our prayers so, what you are doing is one of the most important undertakings, relative to Public Health, i think, in a century so, doctor pangalos, astrazeneca is operations in the United States. The uk standards differ from the fda. How are you going to meet this challenge . As a global multinational company, we get our medicines approved around the world on a regular basis, understands that were working to in the u. S. Is set by the u. S. Fda, both for Manufacturing Development perspective, we are also working excuse me. Will there be a time difference between what is approved in the uk and what you would seek to have approved in the u. S. . There will depend on the data that each of the countries used to get approvals. We have ongoing studies in the United Kingdom that the infection rate is low, we have studies going on in south africa and brazil. I think all the regulatory authorities are working as fast as they can. This will be the data from all of our studies, when we get approval around the world. Thank you very much. I know that the Ranking Member of the full committee, mr. Walton, asked a question about dosages, whether it would be one or two, and i want to follow up on that. If there are, too hard for how far apart will they be . Im most reports that i read, have 55 and older in there in their trial but in order to, there is something about the dosage here, if your dosing for 55 and older, it is like the influenza shot. You need the super duper one to be effective and for younger patients, for children, young adults, you dont need that higher dosage. How are you all going to handle this . I cant remember who said they thought they were doing, or would have to do two doses so, maybe the two dose companies can answer that. I can speak for astrazeneca. I dont have a lot of, time to do it quickly. Were veering towards two doses, and youre actually right, the different populations may require different schedules. Our First Priority is to demonstrate efficacy and the best way of demonstrating efficacy is maximizing those. Well almost definitely go with two doses but for example, the 18 to 55yearold need a single dose, but we will start with two, almost definitely. Are you the only ones anticipating two doses . John pfizer. We also anticipate that it will take two doses into our pivotal trial. The second as would be minister 21 days after the first dose. We studied our phase one trials to date. We are going to try and find the optimal candidates to take into our phase three studies so that we end up with a single construct dosage for both older and younger patients, and safety in effectiveness across the age groups. I thank you all for that, and while i know you are not a scientist by reputation you are humanitarian, so i would salute you for that. Why did pfizer choose not to take any government money, and take it all on yourself, as well as the risk . Great question, and then our focus, as i mentioned my oral testimony, as we recognize that the world is in a completely unique situation, and we also recognize that given the experience we have on the company, vaccine of element company, but also giving the financial that we are maybe uniquely placed, in order to be able to move as quickly as we possibly could and slow speed has been our priority while making sure that we obviously maintain a focus on safety, and that really underpins our decision not to seek government funding for our program. I thank, you and i think the chairwoman, and the chairwoman of the full committee, all of the witnesses. Let me put it this way. God speed. I yield back. You thank you. So, we go to members of the subcommittee first. So, i yield to the gentleman here for five minutes. Mister chair, can you hear me . Well, thank, you and thank you to the subcommittee for arranging this hearing into our witnesses for your participation. This committee has held many pandemic preparedness hearings over the years, and weve consistently heard the manufacturing and enough ancillary surprise needed to go with vaccines, such as violence oranges another material, is an essential component for administering the vaccine. We all remember what happened in the spring as states and hospitals scrambled to compete for basic critical supplies like a 95 masks. So, now as we look towards an unprecedented effort to manufacture a vaccine for the entire globe, theyre increasing concerns about the availability but all the insular supplies needed for a vaccine. With so much riding on a vaccine, we will have to find ourselves in another situation of widespread shortages of critical supplies when it comes to vaccinating people around the world. So, mister young, if a vaccine is approved, media nothing fillers applies to administer hundreds of millions of doses in a compressed timeframe in this country alone. What steps are you taking now to ensure that you will have those sufficient supplies . Thank you for your question. So, as i mentioned my testimony, we have engaged to deploy capital and of a contract in place, at risk, with our suppliers so, weve engaged with suppliers of glass, of stoppers. Were also doing a lot of work to invest in the development of that supply chain, that we want to be critical to get those vials from our manufacturing site two clinics. All of that work is requiring capital, which we are deploying at risk, and so the thing we have done is to engage early and invest early in that supply chain. Thank you very much. And doctor pangalos, presumably, every company in the world working on a vaccine will be competing for the scarce vaccine supplies. You state your testimony, and i, quote and other Companies Involved in this project view this is a competition against each other. Our sole adversary is covid19. So, my question is, is astrazeneca coordinating with other companies on this production and procurement of vital supplies, or, will you be competing against each other for them . Thank you for the question, congressman. So, i think, first of all, we are all using such a different technologies so we are not necessarily competing to the same row materials and so i think that is a benefit. I would say, from astrazenecas perspective, we have created our supply chains in a way that they are not competing with each other so we have a supply chain in the United States, is pledging for the uk, supply came for europe, and the supply chain for the international region. As a calm sequence, are protected from one another and we are making sure that each one of our supply chain in United States, we are working with our own facilities, such as emergent and mris so we feel confident in the quality of strength of our supply chain. Thank you, and as i mentioned, this past spring, it was chaos estates hospitals scrambled to bid each other. As we heard from governors testified before our committee, the federal government did not effectively coordinate ppe distribution at the national level. In some cases, made it watch worse so, doctor hoge, moderna received 53 million deal 53 Million Dollars from b. A. R. D. A. To expand its manufacturing capacity. What guidance or coordination is your company receiving from the federal Government Regarding the production and availability of vaccine ancillary supplies . And is that going to be again a situation where every company is going out there for itself . Thank you for the question, congressman. We, like other companies on the panel have been working with suppliers to specifically purchase all the necessary ancillary supplies that you have mentioned, including glass and stoppers in the like. We have been working with barr to directly, for the grant you just mentioned, to provide transparency to them on those purchases, those contract. Purposes that is twofold, i think that gives them confidence that they have ridden cnn supply and we do have what we need but it also gives transparency to the u. S. Government where we are producing the supplies and certainly if the unfortunate circumstance arose that our vaccine was not successful, i would imagine all of those would be made available to other vaccines. Thank you very much. Well, i think all of our participants. The availability of the ancillary supplies necessary to administer successful vaccine will require coordination, and i am pleased to hear that pass supply failure but his administration is very wary. So, with that, mister chair, i yield back. And thank you. Thank you, mister tonga. Next, mr. Carter is recognized for five minutes. Thank, you mister chairman. I think all of you for being here thank you for your efforts. These are extremely important need to tell you, that you need understand how important this is, and we appreciate all the efforts being made here. You know, ive always said that i think there is a difference in knowing something and realizing something we have known for quite a while now that we are too dependent on other countries for our medical supplies and during this pandemic, i think we have realized, it and one of the things that we have realized is that 72 of all the active pharmaceutical ingredients in the u. S. Supply chain are manufactured in different countries, and in fact, in more than 150 countries. 30 of it comes from china alone is. Weve witnessed this as well and march in india, and even with 26 drugs from exploitation, this is a serious issue, increased removed and we have been doing everything we can to increase domestic manufacturing. In fact, the legislation and eight app will incentivize pharmaceutical manufacturers to bring their manufacturing back to america. I want to talk specifically about the vaccine, hes and i want to find, to specific to your vaccine, how much of the material that is using your individual vaccine, and in your product, comes from overseas . I will start with you, go, sir, pangalos. So, our u. S. Supplies, all of our u. S. Supply chain, it will be coming from the United States. All of it . Yes. What about vials . What about the other things that are used, such as, vials or other delivery methods . Anything at all . Even packaging . To the best of my knowledge, all of the materials that we are using for our u. S. Supplier coming from the United States. I can check that confirm it for you. And are you manufacturing the vaccine in the United States . Is that your intention . Yes, we are. Okay. Doctor doctor douoguih yes for some. 95 of our materials come from the u. S. So, we have very little coming out of china, and in terms of how much manufacturing we have in the u. S. , its roughly half of our supply will be produced in the u. S. And then the other half will be produced in europe . There will probably be a number of facilities in order to best important a Global Supply of our materials. Any in china . As far as i know, im not aware of that, but these discussions are ongoing. Okay. Dr. Gerberding. Okay, thank, you are going to have to get back you for the record on this. We are prosecuting to vaccines and while generally speaking, we have several, theyre very much luckless the night in states and other places in europe. I need to verify the entirety of the supply chain to make sure. If you get back to us in writing i would appreciate it. Doctor hoge . So, our manufacturing domestically is it to facilities in United States. The vaccine is may entirely in the United States. Our supply chain includes a number barometer ill, some of which have been source international, but we work to secure that supply and bring it into depots in advance of native or for manufacturing. And you define internationally . Does that include china . I do not believe so, sir, but i think there is a lot from europe. For david im sorry, does that include china internationally . It may include for some of the raw material, sir, but i dont believe it is a major component. Most of what i was describing was europe. Mr. Young, finally, you. Thank you for the question. As i mentioned, we will have a dedicated supply chain for a vaccine if successful for the United States parameters for a vaccine trump so persons are procured manufactured in the United States. Our drug substances made within our kaiser network, as well as the final product files that will go to a health care professionals. Okay, good. Doctor young, while i have you here, the fda has released guidelines a learning the conditions for approving the covid19 vaccine. Do you believe these guidelines are fair and are they achievable, particularly given the timeframe that we are working in now and the development of these vaccines . Thank you again, sir, and your question i believe is absolutely critical, ultimately, to addressing the confidence issue that i think weve talked about previously, and i think we are to be commended for very proactively releasing guidelines that are evidence based, very clear transparent around the standard that they can expect for both safety and effectiveness. I think they should give a lot of confidence to every american that a vaccine, if approved, is going to meet High Standards for both safety and effectiveness. Goo you are an needed now. Thank you. Thank you madam chair. I thank the witnesses for doing so much to educate the American Public about the potential for a vaccine in the coming months. Six months ago today, the cdc report of the first case of covid19 in the United States. In the months that followed, American Life has been offended, in which we face an unprecedented Health Crisis in this country. Lack of ppe are still plaguing our Health Care System, and with no clothes we define coordinated strategy, the administration inaudible the virus continuing to spread around the country. Congress has a lot of money allotted money for testing, yet, without a coordinated National Strategy inaudible . Obviously, while not directly related, it is important for congress to ensure similar accessibility problems do not occur when a vaccine is determined even if i could provide some level of community. Im encouraged by some of the early trials from these vaccines and im hopeful that the later face trials will prove the vaccine is safe and effective for mass production. However, the accessibility of this vaccine for americas from all walks of life is critical and that is where i want to focus my question. Cases across arizona, and across america, and some of the earliest case occurred on tribal lands in my district including the nomination inaudible government respond to our tribal nations to ensure they have the proper ppe. My question is for the entire panel,. And i know that you all a currently in stages of testing vaccines. Your planning for later stage trials with more people. What is your company doing to ensure that there is broad representation across racial and ethnic groups among our participants . Are there any difficulties that Congress Needs to be aware of while the covid19 packages me being negotiated. I would like to understand a little bit, inaudible i will start, and thank you for the question. We absolutely support making sure that our vaccine through Clinical Trials is tested, is diverse tested and as diverse a community as possible, but to give it confidence that it will be effective in a community that will represent populations all around the world and while we are running cities in the United Kingdom in south africa, south america, and in the United States to begin with, we are also going to other regions such as japan, china and elsewhere. Excuse me but yes, we also need to make sure that within the United States, also, we have diversity in terms of the communities in the populations that we are testing in, and in our 30,000 patients study, working with the nih, we will make sure that we have the diverse populations to present both Ethnic Diversity as well as age diversity. Thank you. Next, please . This is macaya douoguih, i can go next. So, we are still in the planning stages of our phase three study but we do plan to include a diverse population not only from an age perspective but for many of the communities that you mentioned. To do that, we are launching a Community Outreach program that will involve digital platform, but also leveraging some of our existing networks and connections in the context of some of our other programs for example, weve had a very long history of doing a chubby vaccine trial work with the nih and their networks and have a very Strong Community Engagement Group that is very active in the communities that youve mentioned. We want to work in part and lovers experiences we already have because populations are also disproportionately affected by covid, make sure that they have information about the disease, and the vaccine trials that were planning an ample opportunity to determine whether or not you want to participate. So, it is the past experience that people use to help improve the diversity in our trials. I dont chairwoman, i yield. Thank you. I think the gentleman for yielding. Do we have any other members who im not seeing my screen, and have the opportunity to ask questions . Seeing none, i want to thank all of our witnesses for their participation in this very important hearing today and i think i speak for all my colleagues on both sides of the aisle when we say we wish you well, we wish god speed, we wish the development of not just one, but more than one safe and effective vaccine so that we can have we hope by the end of this year or next year and then of course the challenge wouldnt be producing it, distributing it and convincing everybody to take it back. But i want to remind members that pursuing to the Committee Rules they have ten Business Days to submit additional questions for the record to be answered by witnesses who have appeared before the subcommittee and i would ask all of our witnesses to respond quickly and promptly to any questions that you may receive. I would ask unanimous consent to insert in the record the following documents, a report from the republican staff on vaccines and therapeutics dated july one, 2020, and a letter from Retractable Technologies representative bridges, dated july 4th 2020. Without objection, so ordered and with that again, thanks to all of our witnesses and the members. Thank you for being, thank you to mr. Pallone for filling in what we all had to go vote and with, that the subcommittee is adjourned. Today, a Senate Commerce subcommittee will examine various scams that have surfaced during the coronavirus pandemic and what can be done to protect the public. You can watch the hearing live at 2 30 pm eastern on cspan three. After that, President Trump holds a News Conference with reporters at the white house. He will address a range of issues, including the coronavirus response, Race Relations in the u. S. Economy. Watch the president s remarks live at 5 pm eastern, also on cspan three. The president of the Federal Reserve bank of dallas, Robert Kaplan joined a National Press club to talk about the National Recovery during the coronavirus pandemic. He outlined what is needed to turn around the economy, including mask wearing to prevent the spread of covid19 and to improve consumer confidence. Hello and welcome to the National Press club. I am kimberley adams. A member of the nash null a hosting correspondent for the radio marketplace. We are pleased today to welcome Robert Kaplan, president and