Within minority communities toward the medical industry. Thank you to all of our witnesses and, of course, my colleagues for joining us. Todays reading is about the extraordinary effort underway to develop a vaccine to prevent covid19, safe and effective vaccine could hasten the end to this disastrous pandemic. But the herd immunity that would in covid19 once and for all requires all of us, all of us to get vaccinated. For that we need public trust in this entire vaccine project. Around the globe nearly 200 vaccine candidates are being developed and over 20 have entered human Clinical Trials. In the United States, five entered human Clinical Trials with large Clinical Trials that begins later this month. With a historic all hands on deck effort underway around the globe, the timeline to develop a vaccine may be compressed from several years down to just 12 or 18 months. However, moving with this amazing speedos not and must not allow for getting any corners. Today we will how we must place trust in the food and drug administrations tried and tested vaccine review process. We will learn how this process remains the best in the world, and we will hopefully through this process produce a covid19 vaccine in record time. While this nation scientific workforce spans late nights in the lab to produce the vaccine, we in Congress Must do our part to protect their work from political meddling. So that they can uphold their professions utmost standards and scientific analysis and ethics. We are not here today to place the kind of vaccine horserace. Relieve the careful assessment of individual vaccines to the experts. We must entrust science to the scientists, not the politicians. I want to highlight to guard rails that protect the integrity of Vaccine Development and will ensure the safety and efficacy of a covid19 vaccine. First, the most important hurdle for a vaccine to be deemed safe and effective is to successfully undergo phase three human Clinical Trials. According to tradition as well as the science, phase three human Clinical Trials must include at least 30,000 people. This is a requirement endorsed by nih director francis collins, and our top Infectious Disease authority, dr. Anthony fauci. Second, fda must receive and consider advice from what is called the vaccine and related dialogical Advisory Committee, also known as vrbpac. In the area of vaccine, vrbpac has a sterling reputation and for decades it has played a central role in sbas process for assessing new vaccines. Review of a covid19 vaccine by this body of vaccine experts from academia and industry will add transparency, public accountability, and scientific insights into the approval process. These are critical values for a vaccine that will undergo intense public scrutiny and required full participation and trust by the public. However, up to this point fda has failed to commit to these guardrails with fellow oversight chairs Carolyn Maloney and jim clyburn, i wrote to fda commissioner hahn asking for his commitment to a 30,000 trial participant requirement for stage three human trials, as well as engagement vrbpac. A month later we precede no response. Two weeks ago fda commissioner hahn testified to congress that he was named in his bed and a High Standard of the fda. Commitments to a 30,000 trial Participation Rate as well as engagement with vrbpac would be concrete ways to guarantee that independent and rigor. We must remain vigilant to the [inaudible] political tactics or media campaigns. It does not follow Consumer Sentiment or approval ratings. The impending elections, the stock market and yearning for return to normalcy must not distort the decision on whether or not to approve a a vaccine. We must expedite development of vaccine, but we cannot cut corners in the process. With that i would now like to recognize the full committee chair, Carolyn Maloney, for her opening remarks. And thank thank you, chairwoman baloney, for joining us as well. Thank you to all of my colleagues, and i especially want to thank each of our witnesses are joining us this morning to hear from experts about the importance of promoting transparency to ensure that the Coronavirus Vaccine is pretty safe and effective. Where fortunate to have such a distinguished panel of Public Health experts for the subcommittee to integrate for your taken time out of your schedule to share your insights with us. I would like to take a moment to recognize dr. Jason schwartz of the yale school of Public Health. The privilege of hosting last may for a vaccine roundtable at Hunter College in new york city. Im delighted to see again, dr. Schwartz. Thank you for joining us. Finally, i want you really, really command the leadership of chairman krishnamoorthi inconvenient todays briefing to ensure that a safe and effective Coronavirus Vaccine is developed and made available to the American People following the protocols of the fda to ensure safety for our people. I am so grateful for your leadership and ungrateful to be a partner with you on this very critical issue, and i yield bac back. Thank you. Thank you very much, chairwoman baloney. Sorry for the delay, folks. Its just a way to make sure each of us gets unmuted so you can hear us when we talk. Now i would like to turn over to Ranking Member cloud for your opening remarks, sir. If you would like to if someone could unmute mr. Cloud. Hello, hello. Can you hear me . Yes. Good. Thank you, chairman krishnamoorthi for holding this ring. This is certainly an important topic as were dealing with a pandemic that has ravaged our nation and indeed the world. Its important we come together and address these healthcare issues very intentionally. I would note just bite off the top that we have the ability now to hold hearings as opposed to briefings. Hearings which would follow rules and i would just request that as majority considers future hearings that we would conduct them in a format that would protect minority rights. Over the last few months our country has been affected by this, and congress has provided 3 billion for research and development, vaccines, therapeutics and diagnostics for covid19 through the cares act. The Trump Administration has worked tirelessly so our country cant overcome the unprecedented challenge of this virus poses and she would find the best therapies to treat covid19 and can develop a vaccine in record time. To this and President Trump initiative operation warp speed which empowered our government to work with the private sector to manufacture 300 million doses of approved vaccine with the goal of having those by january 2021. To this end President Trump initiated excuse me because of this immense effort government and pharmaceutical companies, the u. S. Is on track to have an effective vaccine widely available by the end or early, early 2021. This of course is an incredible feat in contrast or in context, the h1n1 vaccine was developed in six months but he relied on nearly 70 years of flu vaccine research. It took eight years to develop an ebola vaccine. The American Public should rest assured that the administration and Industry Partners are not sacrificing safety or efficacy while developing this vaccine. We will not be cutting corners in the development of this vaccine. Instead, operation warp speed enables steps in the vaccine process to happen simultaneously. It doesnt skip steps. It just allows them to be done simultaneously. This does increase the cost of production. Drug companies and the federal government have partnered together to cover the costs so we can get the vaccine to market faster. Just last week the federal government announced two new contracts and one with most of these countries have agreed the doses manufactured under these projects will be owned by the federal government. Meaning that if this vaccine a proven effective, u. S. Government would make the doses available to americans at no cost. Other Companies Like moderna and astrazeneca have pledged to set low prices on any vaccine approved. The goal is that between the low prices and existing programs that no one would go without a vaccine who wants one. Finally, ensuring equitable access to the vaccine once developed is key. The cdc has been working since able to develop a ranking system for vaccine distribution. Those serving on the front lines like our medical professionals, those with underlying conditions and those over 65 will likely get the first doses ensuring our most vulnerable are protected. I look for to hearing from the pedals today on how we can assure the public trusts vaccine and has access to it once it is developed. Thank you, chairman. I yield back. Hey, thank you so much, Ranking Member cloud. Its great to have you at this hearing and i really appreciate your remarks. I think were much better off when edwin is participating and asking the tough questions, and that produces a real robust conversation, so thank you. Let me now turn to our briefers. We have five witnesses. And is going to quickly say their names and then going to turn it to dr. Gellin but we have triple, dr. Goodman, dr. Karron, dr. Schwartz. We are now going to start dr. Gellin. You are now recognized for five minutes. Theres a timer on your screen, and i appreciate you all, and all of us, sticking to our five minutes. So with that, dr. , dr. Gellin,u are now recognized. Thank you. Can you hear me pgh yes i can hear you. Thank you. Ill look for the timer, thanks. So good morning chairman krishnamoorthi and members of the subcommittee. Thanks that this Book Discussion today and for the work youve already done to ensure the response to the covid19 pandemic is guided by the best science and the best scientists. Icarly served as president of global immunization at the Sabin Vaccine Institute in washington. Founded in honor of doctor albert sabin, the inventor of the oral polio execute our mission is to make vaccines were accessible, enable innovation and expand unionization across the globe. My entire career stems largely in the government business and faxing focus at cbc, nhf or 15 years as Deputy Assistant secretary help address the National VaccineProgram Office at hhs. As you already were ultimately with the starley and deeply disturbing statistics of this pandemic. The u. S. Continues to experience record numbers of infections and the virus has taken a of american life. Andy on the obvious Health Impacts no sector of society has been spared and the full economic and social reckoning will be grim though still difficult to predict. While the various efforts to flatten the curve of social distance come handwashing and face coverings are all important helped to control this virus, its clear that only population wide immunity will dampen the ongoing spread and end the pandemic. Let me repeat. Only population wide immunity will stop the spread of covid19 and end the pandemic. As you mentioned theres been an unprecedented effort to develop and apply vaccines for the u. S. Population and around the globe. This has been extraordinary and marked by collaboration, innovation and speed. The focus of todays previous how we ensure all of this result in vaccine settable safe and effective. In addition to good science which is always a good starting point, i would suggest there e three crucial elements that a fundamental to the success of this effort. No shortcuts, transparency, and trust. Let me elaborate briefly. The development of successful human vaccines is a complex and lengthy process. In response to this emergency a number of steps have been taken where steps can be taken in parallel rather than in sequence to shorten these timelines without sacrificing a thorough assessment of safety and efficacy. The fda is to be committed for publishing a detailed guidance document on the development of covid19 vaccines. Guidance like these while directed industry are really for all to see so all considerations go into the process. But theres where the pressure to rush these vaccines to the American People at warp speed may be well intended, they have well intended but misguided desire to shorten those timelines. Shortcuts could shortchange the process and we all know that cutting corners comes with a price. The consequences of such a misstep or such as a failure to detect safety signal that wasnt expected would have serious implications. Not only to the risk of people, we risk much more that trust the American People in the very process we have come here to discuss. A recent poll found only half u. S. Adult population would take covid19 vaccine. A third are not sure and what if i say absolutely not. These results are a window into the conference the American Public ask about this process. In 1972 Congress Passed the federal Advisory Committee act which lists are best experts of either independent advice to government and these needs are open to the public and because transparency is an important element in the trump equation i strongly recommend any vaccine that is being considered for any type of approval by the fda be reviewed and open Public Meeting of sbas vaccine and related biological product Advisory Committee. As a past participant i can assure you about the robust discussions that they would have. Without such a public review i have no doubt stories will appear about vaccine approvals made behind closed doors because the government didnt want the public to see what or whom men influenced those decisions. Though stories are impossible to stop and the best edit it would be some shocker while we are to talk about the processes in place to make a vaccine would be safe and effective we should also acknowledge were here to talk about trust trust in research and Development Process in which the vaccine licensure is come trust in a vaccine policy process by which a vaccines are recommended come trust in the provider recommends and administer vaccines, to the patient and trust once vaccines are used broadly in a population that there is a system that continues to assess the safety and effectiveness. In the end, americans want to know and understand what the process is and want to be assured the process is being followed and not shortcircuited. They need to all this to build trust and confidence so when they come to weigh the decision of the benefits and risks they will choose to be vaccinated when a vaccine becomes available. I have no doubt when a vaccine is available, the Vaccination Campaign in use would be visible to all americans. Given some of the frustrations and delays and critical of its of the Pandemic Response to date lets not repeat that pattern. Its not too late to put up plan in place and community to all people want and need to know. People are tired of hearing were building the ship before sailing it. Lets build a, finn sailor. Nobody wants it to sink. In conclusion the guard rails to ensure a and effective vaccine beyond compliance rosary to a skunk whats not assure a Successful Campaign that will then end this pandemic. There must be transparent in the vaccine developed developer pr. There can be no shortcuts in and trust must be built and rebuilt among the government, Vaccine Developers and the public and when you do get started on these matters. Thank you. Thank you, dr. Gellin. Next i would like to recognize dr. Goodman. You have five minutes. Can you hear me now . Okay, great. Good morning, chairman krishnamoorthi and other Committee Members. Im an Infectious Disease physician and professor at georgetown. I was formally fdas chief scientist and director effect d lead many Public Health responses. Before that i directed center for biologics evaluation and research, the resident that assesses and monitors vaccines for the u. S. And news. I do appreciate the opportunity to be here today. Public health measures, diagnostics and treatment can save lives but only vaccine offers a potential provide widespread in the and stop this outbreak before it simply turns to the worlds population. For this reason there unprecedented effort to accelerate Vaccine Development that weve heard about. However, vaccines veltman and manufacturing are complex, success is never assured, and while we can speed the process, we must not cut corners. We must ensure any Covid Vaccines are safe and effective and maintain public trust which is already to do so fdas independent should be protected and agency must uphold be transparent about its standards and scientific decisionmaking. In a recent article colleagues and i outline four safeguards needed in covid19 Vaccine Development. First, we need strong evidence of effectiveness. This is best accomplished in a large controlled Clinical Trials involving thousands of individuals that compare rates of illness in vaccine and control groups. To ensure vaccines work and tho