Transcripts For CSPAN2 Hearing On Vaccine Research Developm

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

Help contain the largest Public Health crisis the nation has faced in over a century. The extent of the crisis cannot be overstated. Six months, over 3m people in the United States have been diagnosed with covid19 and more than 140,000 americans have died. Sadly these numbers will only continue to increase as new covid19 cases are searching all across the nation. I is possible. They also appreciate the chance to bring some ten i ten unseat e Trump Administrations work speed effort. This transparency will be crucial to secure the american Peoples Trust that the vaccine will be made available only once it is proven to be safe and effective. Congress has already taken actions to support these efforts. This spring, congress provided the Vaccine Development and manufacturing of birds and other medical countermeasures. Then two months ago the house passed the heroes act, the comprehensive legislation to strengthen the nations ability to fight the pandemic like altering the Strategic National stockpile and increase funding for Research Development and manufacturing vaccines and treatments. It would also require the administration to get to congress a vaccine plan identifying the activities undertaken to manufacture distributed vaccines safely. The house passed the act more than two months ago and the senate has failed to take it on into the death rates soar. Its compounded by the fact moore could have been done to mitigate a disease. From a number one President Trump has done everything he can to minimize the severity of the pandemic and to undermine his publichealth experts. The Administration Still hasnt developed a National Plan to combat the pandemic. It has no National Test no one in charge of the supply chain and little effort to invoke the defense production act. We are against seeking the resurgence of the same problems that hampered the response efforts this spring such as testing shortages, ppe and medical supply shortages and a tax on publichealth experts. These will likely center for Development Distribution of this before vaccine as long as Congress President and we all want a vaccine to be developed as soon as possible, but before a vaccine is distributed, publichealth experts must ensure the Safe Committee that he band available tevent availad it. My fear. We must ensure the supply chains can safely manufacture the vaccine in the quantities necessary along with other products required to administer. The committee has a long history of supporting efforts related to the developed and playmate and im hopeful if we prioritized the strategic preparations and the administration finally learns from its mistakes that the collective efforts will result in a safe, effective and accessible vaccine coming and i would now like to deal with the remainder of my time to the chairwoman of the house subcommittee, ms. Anna eshoo of california. Hispanic thank you for yielding and good morning to my colleagues and to the witnesses. Each of you represents great hope for americans and people around the world. Speaking of hope, we cant help but think of our colleague john lewis who always said keep your eye on the prize and i think that is what we are talking about this morning because all eyes are on your companies to develop a vaccine that will allow us to return to school, to work out to hug our loved ones and begin a process of recovering from the pandemic. With that opportunity comes great responsibility to ensure products are safe, effective, affordable and accessible so i look forward to hearing from each of you today how you are going to make a transparency and accountability from the american taxpayers and the american patient, how you are scaling up domestic manufacturing thank you again to each of you for testifying. The chair of the subcommittee for holding the hearing and i look forward to not only hearing from you but working with you and i yield back. The chair now recognizes the Ranking Member of the subcommittee for five minutes. Thank you madam chair. Appreciate you holding this critical and important hearing. First i know i dont have to make a unanimous consent request that for the record, ms. Rogers and mr. Carter will be sitting in on the subcommittee. Thank you for holding this important hearing. This before pandemic has been a tough challenge for the incredible effort to develop safe, effective and accessible covid19 vaccines gives me great hope that we are on a promising path to solutions. The unified effort by vaccine manufacturers in the Research Community and federal partners to work with each other is remarkable, and im confident through this unity of purpose, cooperation from a focus on expertise and a tremendous amount of resources. And the accelerating therapeutic interventions for the manufacture and distribution vaccines therapeutics and diagnostics. The testimony today for the witnesses of the vaccine candidates will be a vital interest to the American People. The companies represent the first portfolio platforms with promising primary data for example the experimental vaccine reportedly provided authority by the volunteers with immune responses to the rear generally well tolerated. The university of oxford candidate might complete the trials by september and agreements have been mined to produce 2 million doses by 2021. In addition, there reportedly is positive news on the Response Team from the antibodies in the cells. Last month, some vaccine experts expressed concerns that the Trump Administration and then when it gets assurance that the vaccine will not authorize unless theres 30,000 people in each phase three Clinical Study. It appears such assurances have been made by the Trump Administration. The leading vaccine candidates under the auspices are required to enroll 30,000 participants in the trials. As doctor fauci of the Infectious Diseases at nih and doctor stephen hoge testified before the full committee on june 23, there will be no shortcuts on safety and efficacy standards. The speed is being achieved through the financial risk. I will repeat that, of manufacturers, not safety or efficacy. And accelerating the capacity to this millions of doses and not at the expense of the safety and efficacy. Concerns have also been raised about vaccine content and whether there will be sufficient Vaccination Coverage to ensure her community. We need to have a High Percentage of American People vaccinated to achieve the protective effect of herd immunity to save american lives. Regarding supply, the manufacturing capacity we will hear testimony of how these companies are working cooperatively to address potential supply concerns. These companies in the aggregate are committing to manufacture billions of doses. I look forward to hearing more about how each of the companies before us today plan to scale up manufacturing efforts to ensure an adequate supply of an authorized or approved covid19 vaccine. Finally, access and affordability many manufacturers have told the Committee Staff that if the vaccine effort is successful, they dont want cost to be a barrier to accessing a covid19 vaccine. This is a welcome commitment and we are eager to discuss it further. The mission to get safe and effective vaccines have been a driving force for the committee republicans. At the beginning of this month, leader walden and i released the second wave product with recommendations on how to better prepare the production and distribution of the vaccines and therapeutics. I welcome all of the witnesses and look forward to your testimony and discussion of these issues. Madam chair, i yield back. Todays hearing will examine efforts to develop safe and effective covid19 vaccines. And i know i speak for everybody this morning and saying we are all rooting for a safe vaccine to be developed, manufactured and accessible for all americans as soon as possible. This committee and congress have launched the federal effort to advance the development and availability of the vaccine. This spring we provided billions of dollars in funding to support vaccine Research Development and manufacturing. Further assisting some of the companies testifying today in developing covid19 vaccines. This committee has the responsibility and oversight today we will have the opportunity to hear from some of the manufacturers working on potential covid19 vaccines and how the Funds Congress provided are being put to use in these unprecedented times. I think the witnesses for being able to participate in such a critical hearing and critical time. We are now six months into this national Public Health crisis and covid19 case numbers continue to climb at a staggering rate. Today more than 140,000 americans have lost their lives to this disease. As long as the Trump Administration continues to short the responsibility to lead a coordinated National Response effort, sicknesses and deaths are going up. Its also clear that we are not going to be able to contain covid19 in the United States without a rapid and robust deployment of Public Health measures and medical countermeasures, including a safe and effective vaccine. We note containing the virus as soon as possible is of utmost importance. Billions of americans face continued unemployment and loss of health insurance. Across the country, parents are making impossibly hard decisions about child care and school participation. Frontline Health Workers Comedy Central employees, people of color, seniors and others most vulnerable to covid19 face daily threats to their survival. Fortunately, there are reasons to be optimistic that the search for a covid19 vaccine is headed in the right direction. According to statements from several of the companies testifying today, and based on the speed at which they are progressing through Clinical Trials, it is possible a covid19 vaccine may become available by the end of this year or early next year. That is a bit of good news in this terrifying time. But while some Public Health experts are [inaudible] we must remind ourselves plenty can still go wrong so the anticipated timeline is not guaranteed. Determining the vaccines safety and advocacy is the first of many challenges that must be addressed to manufacture and distribute a vaccine to the americans and people around the globe. While we await the results of Clinical Trials, the necessary manufacturing and distribution infrastructure must be placed or so that its readily available for hundreds of americans once it is determined to be safe and effective. Additionally, as the pursuit of the covid19 vaccine moves forward, we must be prepared not only to produce the vaccine itself, but to have it supplies required to administer the vaccine such as vials and syringes. The Committee Heard from governors across the country just how unprepared we were as a nation to provide basic testing supplies like slobs and personal protective equipment. The lack of this undermines the response effort and we are still feeling the effects today. I have a concern with all of the efforts around the world to develop a vaccine, the government and manufacturers like with testing supplies and pp e. , maybe ill competing for a limited supply of items such as glass vials and syringes. These are critical and ultimately to deliver a vaccine showed one proved to be successful. Further, critical decisions must be made now across the federal Government Cut the industry and Public Health shareholders regarding vaccine rollout efforts and public and provider education. This is especially true given the value of any future covid19 vaccine life and the willingness of the American People to get vaccinated and their ability to access and afford it. Developing and distributing the vaccine requires a National Plan, one o that the administration stated is still being developed despite urging the administration to adopt such a plan two months ago but time is of the essence and now is the time to prepare for a nationwide vaccine program. Developed connie vaccine will be instrumental in protecting the health and wellbeing of the nation. While we are racing for all of your collective success, we must make sure its safe, effective coming and ultimately a portable for all americans who need it. The committee will continue to conduct oversight. These remain the focus of the pursuit for the covid19 vaccine. And with that, im pleased to yield five minutes to the Ranking Member of the committee, mr. Walden. I also want to welcome todays witnesses. We know that you ar that your ho develop the medical countermeasures including the vaccines that they are here to discuss today. We are literally working to save the world. We greatly appreciate you taking the time to participate in todays hearing. Energy and Commerce Committee republicans continue to closely examine Current Issues related to covid19 and how to prepare for an uptick in cases at the same time this season hits this fall. The. [inaudible] the second pillar of focusing on vaccines and therapeutics is includes a series of important recommendations that better position the country to produce vaccines and therapeutics. There are extensive efforts led by the federal government and private sector to develop countermeasures for covid19 including operation warp speed. Operation warp speed is an unprecedented pace to develop and manufacture and distribute covid19 vaccines. One of the many goals is to have as much as 300 million doses of the vaccine for covid19 available to americans by january of 2021. We have been able to identify vaccines and move to Clinical Trials. To put it simply theyve been an integral part and collaboration weve seen over the past few months in the federal government, Trump Administration, private sector is extraordinary and i commend all of those involved. At the june 23 hearing, we are taking financial risks, no risk to the integrity of the financial to be ahead of the game is safe and effective vaccine to be available to the American Public. In addition to the hearing today on an update on the efforts to develop vaccine, we also want to give that unprecedented speed doesnt mean sacrificing safety or efficacy. Along those lines, and also need to know how the companies are helping to build vaccine confidence. This is a critically important topic that spans the covid19 and beyond. Its made more urgent when its proven safe and effective in authorized by the fda. We want americans to feel confident in getting the vaccine. Its also vital when thinking about the fast approaching fall into the influenza season. We need a vaccine that is available but also is accessib accessible. Communities frequently are on the outside looking in but for covid19, no american should be left behind. Continue to work to provide a safe fixing my also the debate could ask you take into consideration a Robust Manufacturing process providing the vaccine in a timely manner to all americans. We also want to hear about the efforts underway to ensure there are sufficient amounts this is another issue we need to be taking [inaudible] if theres anything you need help on from the congress, we want to hear from you. [inaudible] without objection, so ordered. We have several members of the full committee that we will be waiting on a per the hearing today. For the majority congresswoman eshoo, and then we heard from the Minority Congress Mcmorris Rogers and congressman carter. I want to introduce the witnesses for todays hearing, doctor mene pangalos is the executive Vice President of the biopharmaceutical. The head of the Clinical Development and johnson and johnson, doctor Julie Gerberding executive Vice President and chief patient officer of merc, stephen hoge and the chief advisor for pfizer. Thank you for hearing today. Its important to you what you have to say. The committee is holding an investigative hearing and we were things of the practice of taking testimony under a. Does anyone have any objection to testifying under oath . The witnesses have responded no. The chair advises you under the rules of the house and of the committee you are entitled to seek counsel. Does anyone desire to seek counsel during your testimony today . Let the record reflects the witnesses havreflect thewitness. Good news, im not going to make you buy but raise your hand so you may be sworn in. Do you swear the testimony that you are about to give is the truth, the whole truth and nothing but the truth. You are now under oath and subject to the penalties set forth in 18 section 1001 of the u. S. Post. The chair will now recognize the witnesses for five minutes summ

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