Dramatically. I would echo the callers point the Administration Needs to listen to Public Health experts. We know what we are talking about. Let me ask you about a tweet from the president. Lets take you to a Live Committee hearing on how to develop a safe and effective Coronavirus Vaccine. A safe and effective vaccine could hasten the end to this disaster us pandemic but the herd immunity that would end covid19 once and for all would allow all of us to get vaccinated. We need public trust in the entire vaccine project. Around the globe nearly 200 vaccine candidates are being developed and 20 have entered human Clinical Trials. In the United States five have entered human trials with large Clinical Trials that begin later this month. With a historic all hands on deck effort underway the timeline to develop a vaccine may be compressed from several years from 12 to 18 months. Moving with this amazing speed must not allow for cutting any corners. Today we will hear how the tried and trusted vaccine review process. This remains the best in the world and we will hopefully through this process develop this vaccine in record time. This nations scientific warhorse spend latenight in their labs, we in Congress Must do our part to protect them from political rattling meddling. Some standards of scientific analysis and ethics. We are not here to place that kind of vaccine horse race, from individual vaccines to the experts. We must entrust science to the scientists, not the politicians. I want to protect the Vaccine Development and ensure the safety and efficacy of a covid19 vaccine. The most important hurdle for a vaccine to be safe and effective is to successfully undergo phase 3 Clinical Trials. According to conditions, phase 3 Clinical Trials must include at least 30,000 people. This is a requirement endorsed by nih director Francis Collins and top Infectious DiseaseAuthority Doctor fauci. Fda must receive and consider advice for the vaccine and related biological Advisory Committee. In the area of vaccines, they have a sterling reputation and played a central role in assessing new vaccines. Review of the covid19 vaccine by a body of experts from academia and industry will add transparency, public accountability and scientific insights to the approval process. These are critical values for a vaccine that will undergo intense public scrutiny and require participation and trust by the public. Up to this point fda has failed these two guardrails with fellow oversight chairs Carolyn Maloney and jim cliburn, i were to commissioner stephen hahn asking for his commitment to a 30,000 trial participant requirement for human trials and engagement with burbac. A month later weve received no response. Fda commissioner hahn testified to congress about the high standards of the fda. Commissions with 30,000 trial Participation Rate as well as engagement with burbac would be concrete ways to defend that. We must remain vigilant. Must not distort the decision on whether or not to approve a vaccine. We must expedite developing a vaccine but we cannot cut corners in the process. With that, i would like to recognize the full Committee ChairCarolyn Maloney for her opening remarks. Thank you to all your colleagues and i want to thank each of our witnesses about the importance of promoting transparency to assure the Coronavirus Vaccine is safe and effective. We are fortunate to have such a distinguished panel on the subcommittee and im grateful that youve taken time out of your schedule to share your insights with us. I would like to recognize doctor Jason Schwartz of the yale school of Public Health. I have the privilege of hosting him last may, im delighted to see you again, doctor schwartz, thank you for joining us and i want to really come in the leadership of the chairman in convening todays briefing to ensure the safe and effective Coronavirus Vaccine is developed and made available following the protocol of the fda to ensure safety to our people, im grateful to your leadership many grateful to be a partner with you on this critical issue and i yield back. Thank you very much and sorry for the delay. It is a way to make sure each of us get an muted so that you can hear when we talk and i would like to turn it over to Ranking Member cloud for your opening remarks. If you would like so we can unmute. Can you hear me . Thank you for holding this hearing. This is an important topic, dealing with a pandemic that ravaged our nation and it is important to come together and address the healthcare issues very intentionally. I would note right off the top we have the ability to hold hearings as opposed to briefings which would follow rules and i request the majority considers future hearing, over the last few our country has been affected by this, congress afforded 3 billion in research and development and diagnostic for covid19 through the cares act. The Trump Administration has worked tirelessly so we can uncover the challenges the virus poses and ensure that we found the best therapeutics to develop a vaccine in record time. To this end donald trump initiated operation warp speed which empowered our government to work with private sector to manufacture 300 million doses of a vaccine to have those by january of 2021. Donald trump because of his immense effort, to have an effective vaccine widely available by the end of early 2021. This is an incredible feat in context, the h1 in one vaccine relied on 70 years of flu Vaccine Research, took eight years to develop an ebola vaccine. The American Public should rest assured the administration and interested partners are not sacrificing safety or efficacy while developing this vaccine. We will not be cutting corners in development of this vaccine, it enabled this to happen simultaneously. It just allows them to be done simultaneously. This does increase cost of production, Drug Companies and the federal government partner together to cover the cost but we can get a vaccine to market faster. Last week the federal government enough two contracts, most have agreed the doses manufactured will be owned by the federal government meaning if the vaccine is proven effective the Us Government would make the doses available to americans at no cost. Other Companies Like moderna and astrazeneca put low prices on any vaccine approved. The goal is between the low prices and existing programs no one would go without a vaccine. Finally insuring equitable access the cdc has been working to develop a ranking system for vaccine distribution. Those serving on the front lines like our medical professionals or underlying convictions will likely get the first dose ensure you are most vulnerable are protected. I look forward to hearing from the panelists today, and have access once it is developed. Thank you so much. I really appreciate the remarks. Everyone participating and asking tough questions and that produces a real robust conversation. We have five witnesses. I will quickly say their names, doctor guillen, doctor goodman, doctor karen, doctor schwartz, we are now going to start with doctor guillen. You are recognized for five minutes. There is a timer on your screen and i appreciate you and all of us speaking for five minutes. You are recognized. Can you hear me . Banks. Good morning, members of the subcommittee. An important discussion today and the work youve done to ensure the response to the pandemic is guided by the best science and best scientists. Im doctor bruce guillen advisor with the safe Vaccine Institute in washington. The inventor of the vaccine, to make vaccines more accessible, enable innovation across the globe. The cdc, nih and Deputy Assistant secretary for health, at hhs, we are familiar with the deeply disturbing statistic of the pandemic, the us continues, the virus has taken a disproportionate number of american lives and to be on the Health Impacts no sector of society has been spared at the economic and social reckoning will be grim and difficult to predict. Various efforts to flatten the curve, social distancing the handwashing and face covers are all important to help to control the virus, it is clear that only population wide immunity will dampen the ongoing spread. Only population wide will we stop the spread of covid19. There is been an unprecedented effort to develop and deploy vaccines for the Us Population and around the globe. This is extraordinary and marked by collaboration, innovation and speed. The focus of todays briefing is how we ensure that all of this is safe and effective. In addition to good science which is a good turning point, three crucial elements in the success of this effort. Developing a successful human vaccine, steps can be taken in parallel and without sacrificing an assessment of safety and efficacy. The fda is to be commended for developing a vaccine, directed to industry, so all other considerations go into the process but a lot of effort to push these to the American People at warp speed may be well intended but misguided desires to shorten this, shortcuts could shortchange the process and we know cutting corners comes in a price. The consequences of such a misstep, what wasnt expected would have serious implications, to trust the American People, the process we have come here to discuss was a recent poll found the adult population, and these results are a window into the confidence the American Public has about this process. And the Advisory Committee act, the best ever to provide independent advice to government in these meetings are open to the public and transparency in the trump equation i recommends, any type of accrual by the fda, with the related biological products. In that committee, the robust can additions they have. Stories will appear, vaccine approvals made behind closed doors because they didnt want the public to see what or who may have influenced those decisions. The best answer that would be some shock. And they would be safe, helping our trust. Trust in the research and development process, vaccine licensors, trust in a vaccine policy process, trust in the providers who recommend administer vaccines to patients and once vaccines broaden the population there was a system in place that continues to assess those efforts. In the end americans want to understand what the process isnt being filed and not shortcircuited. And to way their decision this, they choose to be value vaccinated when the vaccine comes available was at no doubt when a vaccine is available a Vaccination Campaign in the us will be visible to all americans and given the frustrations and delays a critical element of the Pandemic Response lets not forget that pattern. Its not too late but a plan in place to communicate to all who want and need to know. People lets build it and sail it, nobody wants in conclusion the guardrails ashore safe and effective vaccines beyond compliance with rules and regulations, compliance will not assure a Successful Campaign that will end this pandemic. There must be transparency in the Vaccine Development process. There can be no shortcuts in the bill for rebuilding the government Vaccine Developers in the public, need to get started on these matters, thank you. Thank you. Next i would like to recognize doctor goodman for five minutes. Can you hear me now . Good morning Committee Members. Im a disease physician and professor formerly fdas chief scientist and helps with many Public Health responses and i directed the center for biologics evaluation and research, monitors vaccines for us news and i do appreciate the opportunity to be here today. It can save lives for the potential to provide widespread immunity and stop the outbreak through the worlds population. For this reason there unprecedented references to Vaccine Development we have heard about. The manufacturing is complex, success is never assured and we can speak the process, we must not cut corners. We must assure any covid19 vaccines maintain trust. And the agency must uphold and be transparent for standards and scientific decisionmaking. In a recent article that outlined four safeguards in development. Strong evidence of effectiveness. This is best accomplished in large control Clinical Trials involving thousands of individuals and vaccinated and control groups. To ensure things worked and those who need the most trials must include diverse populations as well as elderly and conditions. Fda recently published guidance that it should be 50 effective, a reasonable starting point. The effectiveness of covid19 vaccines is not different. Against other corona viruses and immunity may wayne quickly. We need strong evidence of safety. Unlike treatment given to the sick vaccines are given to the healthy and must be extremely safe. This is a novel disease for which we have no vaccine precedent and many are based on novel technologies not yet utilized to ensure that they have preapproval safety databases that increase 7000 individuals. In addition, safety and general population factors studies should move ahead given the risk they face in their roles with other essential workforces. We need to be thoughtful about Vaccine Access prior to approval. There may be circumstances of unapproved vaccine, appropriate for severe output. It is not submitted, fda provides access to expanded Access Program or emergency use operation. The us is designed to enable responses in Public Health emergencies but have lower evidence in fdas normal effective standards. It may be effective and many benefits outweigh risks. It is the same as approval. Vaccine used turns out to be any effective or raise safety concerns and users are unclear that it was unapproved, a crisis did occur and therefore a vaccine is used, informed consent to be part of the process and be targeted to those at highest risk of infection and complication. The highest safeguard is robust Monitoring System as things are rolled out. It was not detected for preapproval. Also the vaccines administered occur coincidentally after vaccination and it is critical to ashore. The 2009 h1 n one vaccines the system captures government and private sector data first vaccine doses. To communicate that the vaccines were safe. We need a system in place now, not later, with full transparency how safety will be monitored and communicate. While working to get covid19 death quickly, these safeguards are sure will be safe, effective and trusted. Thank you, i look forward to the discussion. Thank you, next, doctor karen, have i pronounced your name properly . Yes you have. You are recognized for five minutes. Good morning. My name is ruth karen, pediatrician chain trained in Infectious Diseases and professor Bloomberg School of Public Health where i lead the center for Immunization Research and the vaccine initiative. My work is focused on respiratory virus vaccines and vaccine policy, with respect to covid19 vaccines, likely be a coinvestigator for two other vaccine trial scheduled to begin this summer. I had the honor and privilege of serving on two federal Advisory Committees, i served as chair of burbac at a cip, the cdc Advisory Committee. More than 3 million americans have been infected with the virus and more than 137,000 have died. This virus profoundly affected us all. For racial and ethnic minorities, the development of covid19 vaccines, vaccines will be the best tool to this pandemic. This is not a competition. Most vaccines increase the chances that we will have effective vaccine for sufficient quantity to affect people worldwide. The populations included in vaccine trial, the necessary safety and efficacy data to inform decisions about vaccine authorization licensure. We need to plan for the careful, open and transparent evaluation of all trial data. To protect all members of our society. This will be critical if the fda reviews vaccine trial data without making decisions about emergency authorizations, the review of trial data and recommendations for licensure, two important purposes, the public and fda have the opportunity to hear about questions and concerns, the leading independent vaccine scientists, the fda and other members have the opportunity to hear and respond to public concerns in an open public forum. This following winter safety and efficacy data will be emerging from covid19 trial. As doctor goodman just described decisions need to be made about issuing euas for one or vaccines with data promising but incomplete. Questions about risk and benefits for populations are high risk groups must be