Microphones anytime you speak. During the any time hearing, the chairman the vice chairman of the committee, congressman kennedy will serve as chair until i am able to return. Beuments for the record can sent to Benjamin Tabor at the email address provided to staff. All documents will be entered into the record at the conclusion of the hearing. The chair will not recognize herself for an opening statement. Today the energy and Commerce Committee continues its oversight of the nations covid19 Pandemic Response. Examining the pursuit of a safe and effective covid19 vaccine that the American People can trust. In the eight months that we battled covid19, over 7 million americans have had the virus, and over 200,000 of them have lost their lives. Millions of the phase unemployment and have lost their Health Insurance, and families are still juggling childcare and virtual classrooms. The list of those most vulnerable to covid19s especially on the line as the virus continues to spread across the country. We know that a safe and effective and trusted covid19 vaccine will be a critical tool to stand this pandemic. I believe that i am joined by everybody in this hearing and everybody in this country and hoping that a vaccine is available as quickly as possible. This summer, we held a hearing with the leading Companies Working to develop a covid19 vaccine. The companies assured us that well the pace of the vaccine is unprecedented, safety and science are not going to be sacrificed for speed. Last month, these companies joined four other manufacturers in a rare joint pledge stating that they would stand with science and not put forward a vaccine until it had been thoroughly vetted. Our commitment will be critical as the future success of a covid 19 vaccine depends on the American Publics confidence that it will be safe and effective. Alarmingly, the public trust in a future vaccine has declined dramatically in just a few months. Nearly two thirds of americans worry political pressure will rush approval of a covid19 vaccine and more than half say even if it were free, they would not get vaccinated before election day. One does not have to search far to find the source of the publics distress. Time and again throughout the pandemic, at the Top Administration has politicized science, undermining its own Public Health experts get every turn, and, in fact, just last night and yesterdays president ial debate meltdown, President Trump called the process a very political thing. The white house and hhs leadership have interfered with cdc guidance and other scientific publications for political purpose. The white house has publicly pressured fda to issue emergency use authorization for prospective covid19 treatments despite objections from fda scientists. And the president unfortunately as attack the credibility of his own Public Health leaders. For example, just hours after cdc director redfield testified on the effectiveness of wearing face coverings at a vaccine, President Trump told the press the dr. Redfield was confused and had made a mistake. The president as politicized the pursuit of a covid19 vaccine repeatedly by claiming it will be available in october before a special date, obviously referring to election day, and he did that again last night. At the president as even accused his own fda of being part of the deep state, suggesting it was blocking a vaccine to hurt his political prospects. Following the reports the fda would be publishing additional standards for emergency use authorization of a vaccine, President Trump falsely claimed that the guide guidance was politically driven. The guidance was praised by external experts but it may not ever see the light of day because of the president s political whims. About thettee oversight subcommittee as been sounding the alarm on the administrations dangerous politicization of science for months, and frankly we are not alone in our concern. Sciencesnal academy of took the unusual step of issuing a statement warning that the repeated politicization of science undermines the credibility of Public Health agencies and the Public Confidence in them at a time when we need most. Fortunately, as we will hear from our witnesses, that there are ample reasons to be optimistic. The search for a covid19 vaccine is and will continue to be driven by science, and i believe there are steps we can take to restore the American Publics confidence. Namely, the Administration Must allow the career scientists at the fda to do their jobs free from political interference, such as allowing the time necessary to give a robust review of clinical findings. It must let fda release the additional standards for emergency use authorization of a covid19 vaccine once it is developed. All of us on this committee, democrats and republicans, are rooting for a safe, effective covid19 vaccine accessible to all americans, and we will continue our oversight until these goals are met. We will also continue to call for a comprehensive covid19 vaccine plane. I look forward to hearing from the panel today. Hopefully, our wonderful experts can help guide us on ways to help ensure that the public as full confidence in a covid19 vaccine once it is made available. I also hope that they can provide Additional Solutions and a suggested guard rails that will ensure science and not politics guides in the way, because the health of our nation depends on it. Now i am very pleased to recognize our Ranking Member for five minutes for the purpose of an opening statement. Thank you for holding this important hearing. It will be a vaccine that offers us the best chance to finally edit this pandemic, allowing our nation to fully reopen, but it is not just the vaccine itself. In addition to an approved or authorized vaccine, we will need widespread acceptance, distribution, and immunization to combat this virus. The purpose of this bipartisan hearing should be to increase Public Confidence in the food and Drug Administration edits processes for authorizing and approving vaccines through science based decisions that there is greatest Vaccine Acceptance and confidence among americans. Congress created the emergency and later expended that pathway and hazardemic reauthorization act on a bipartisan basis. Through those efforts, we provided special reporting to the fda to use in a Public Health emergency prior to full approval when the Scientific Evidence is available to support such use. To receive an emergency use authorization, a drug company must demonstrate based on the total totality of Scientific Evidence the drugs known or unknown potential benefits outweighed the potential risks. The fda can apply that standard appropriately to different settings, such as requiring more , rous standards the fda has announced it is approach. Ua plus through guidance setting stringent more stringent standards for other euas. I have great concerns and were trying to score political points by criticizing the fda in his vaccine review and approval process, particularly undermining trust in the fda authorization vaccine, especially during this Global Pandemic and international emergency. It is understandable that many in the public would be concerned and confused about the Vaccine Development and approval process work orders are being cut with unfounded witticisms circulating. The truth of the matter is that the review and approval stages of the vaccine will be controlled throughout the process but nonpolitical, independent scientific experts, not politicians. The data produced during the vaccine political trials are reviewed and evaluated by a isety monitoring board which composed of independent scientific experts. In addition, there are the fda vaccines and related Biologic Advisory Committee to propose leading experts expected to review the data. Even if congress has contributed to getting assurances on a scientific decision from the fda. It was this committees full Committee Hearing in june and other Committee Hearings over the past few months where congress and the American People received assurances from fda commissioner stephen hahn that he would support his career scientists, and the fda would not cut corners of dirt just over the safety and efficacy. The intense scrutiny is extended to other from highly respected Health Officials. Dr. Peter marx said he will resign his position if the fda or to greenlight an unproven vaccine. The director of the National Institutes of health and the director of National Institute of allergic and Infectious Diseases that they will only back a vaccine that is Science Behind it. Nine Drug Companies have already pledged they will not submit vaccine candidates for fda review until their safety and efficacy is shown in large Clinical Trials. In addition, each of the four companies now in phase three have published trial particles. , twoaccine distribution independent committees will provide guidance. The National Academy of science engineering and medicine and cdc Advisory Committee on immunization practices. I urge each of us to put politics aside. I know what are a few weeks from election, but put politics aside in order to deliver one unified thatsaving message americans can trust the fda vaccine approval process. They will be driven by the science and will result in science based decisions. Lastly, a reminder for everybody to get your flu shot this year will be more important than ever. I look forward to the testimony from these esteemed witnesses and welcome them to this hearing and i yelled back. Shotank you i got my flu too and i echo what you said. Everybody should get their flu shot. We will now recognize the chairman of the subcommittee for five minutes. Thank you. To date we will hear from some of the nations leading Public Health experts about one tool that will help put an end to the pandemic and suffering, and that is a safe and effective and trusted covid19 vaccine. I am pleased that you are all with us so that expertise and science have the rightful place in these discussions. We all want a covid19 vaccine to be developed as soon as possible. First and foremost we must confirm it is safe and effective and trusted and accessible to all who need it. ,s i said in our july hearing my fear is that the Trump Administration might force in the fda to approve a vaccine before proven to be safe and effective in an effort to boost the president s political fortunes. I hope that does not have and im grateful career fda officials have repeatedly stated the importance of putting signs first. Since january, the president as consistently placed politics over science eddie is undermined the independence and integrity of our scientific agents and experts. His words it created confusion amongst the American People, and so it is Little Wonder that pulling noshows public trust in the future covid19 vaccine has declined drastically over the past few months. That is why we have to build back the confidence of the American People as it works to ensure a safe and effective vaccine is developed. We will probably vote on an updated heroes act introduced yesterday. Included in that is 1 billion in funding for an evidencebased Public Awareness campaign to outline the importance of vaccines and combat misinformation, some of which is unfortunately coming from the president. , updated heroes act, there is also 20 billion added to authorize the secretary to provide grants or contracts for vaccine and therapeutic development, 7 billion to conduct activities to enhance, expand, and improve Vaccine Distribution and administration and language to provide grants to state and local Public Health departments for procurement of vaccines. I would also remind everyone the heroes act, as well this updated act, provides free treatment, drugs, and vaccines with no copays, similar policy we had and cares for testing and Contact Tracing with a free testing, in this case free vaccines and no copay. I regret that Mitch Mcconnell and President Trump have really stood in the way of the heroes act that the house passed back in may and i continued to call on Mitch Mcconnell and the president to come to the table maybe before we leave this week we will have a consensus, a bill to follow up act. E cares act it what we continue to see from this administration is political calculation and not science guiding its decision. Now of course the Trump Administration is attacking a potential Covid Vaccine in court because they want to strike out the Affordable Care act and they have asked the Supreme Court to do that. The aca requires that Health Insurance plans cover all recommended vaccines. If it is struck down, we will lose access to health care, including a potential vaccine for those who lose their coverage under the aca. At that to me is an outrage. I look forward to hearing from the witnesses today. I think the Trump Administrations actions would hamper the developments to effectively administer a vaccine. For that reason, i hope our witnesses can [indiscernible] i what guardrails they hope to see employees to keep that from happening. That is one of the reasons i want to hear from you to make sure we can prevent a situation where we have a safe and effective vaccine, we do not people do not want to take it. Thank you again, and i yelled back. Recognizes the Ranking Member of the committee for five minutes. Thank you, and i appreciate you having this hearing. American should have confidence that any vaccine approved or authorized by the fda will have gone through the most rigorous, independent, and transparent trials, testing, and review in the world. The scientific and public Attention Focus on the vaccine process is itself unprecedented. Fda has issued rigorous guidance for these vaccines and each of the phase three trials is enrolling at least 30,000 participants. The fda as multiple existing safeguards in place to ensure an science based decisions. These include standards for the vaccine review process, the emergency is authorization process and necessary evidence required to receive an approval that meets fdas Gold Standards. There are multiple safeguards outside of the fda. Each of the three trials will be overseen by the data safety and monitoring board. That is an independent Multidisciplinary Group which includes individuals experience ,ith Clinical Trials biostatisticians, bioethicists, the facts, and a biologist virologist. And the integrity of the data. In addition, all four companies in phase three trials published their Clinical Trial protocols to provide even more transparency. Independento experts who serve on fda Advisory Committee will scrutinize safety and efficacy data of the vaccine candidate. The evidence requires these vaccines to be consistent with the fda Gold Standard that made the vaccine supply in the u. S. Reliable, safe, and effective. Separately, the u. S. Centers for Disease Control and prevention, the cdc, the adviser reported is comprised of medical Health Experts responsible for developing recommendations on the use of fda approved vaccines for americans, including how, when, and to whom a vaccine should be given. It is incredible that a lifesaving vaccine gets to those most at risk for this deadly virus without delay once the fda independent scientists have glittered for safety and for efficacy. Indicateds now have that they plan to withhold distribution of vaccines while they conduct their own unprecedented review of the data. I think that potentially risk the lives of their own citizens. It would be the first time some of these governors have done that. Such reckless actions dangerously undermine the fda and leave a greater Vaccine Hesitancy and delay and describes distribution. They create public confusion with misleading information without vaccine safety and efficacy, and worst of all, it will jeopardize american lives. These dates have not provided any evidence or any expertise to co