Around the globe, nearly 200 vaccine candidates are being developed and nearly 20 have entered human. Clinical trials in the United States. Entered human Clinical Trials with large Clinical Trials to begin late this month. With the historic, all hands on deck effort underway around the globe come of the timeline to develop a vaccine may be compressed from several years now to just 12 or 18 months. Moving with this amazing speed does not and must not allow for cutting any corners. Today, we will hear how we must place trust in the fdas [audio drop] to produce a vaccine. We in Congress Must do our part to protect their work from political meddling so that they can uphold their professions utmost standards of scientific analysis and ethics. We are not here today [audio drop] not politicians. I want to highlight two guardrails 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. [audio drop] vaccines. [audio drop] a 30,000 trial participant requirement for trials as well as engagement. Haves later and we received no response. Two weeks ago, the fda commissioner said he would maintain his higher standards. Commitment to a 30,000 trial Participation Rate as well as engagement with the concrete ways to guarantee that rigor. We must remain vigilant to the risk it does not follow consumer ratings, theroval impending election and the urine to return to normalcy must not distort the decision on whether or not to approve a vaccine. We must expedite the developing a vaccine but we cannot cut corners in the process. Like tot, i would now recognize the Committee Chair for her opening remarks and thank you, chairwoman maloney for joining us, as well. Thank you to all of my colleagues, but i especially want to thank the witnesses for joining us this morning. To hear from experts about the importance of promoting transparency to ensure the is safe andvaccine effective. We are fortunate to have a panel of Public Health experts before the subject subcommittee today and i thank you for taking time to share your insights with us. I would like to take a moment to dr. Jason schwartz of the yale school of Public Health. I had the privilege of hosting him last week last may in new york city. I am delighted to see you again, dr. Schwartz. Thank you for joining us. Finally, i want to commend the andership of the chairman convening todays briefing to ensure a safe and effective Coronavirus Vaccine is developed and made available to the American People following the protocol of the fda to ensure safety for our people. I am thankful for your leadership and grateful to be a partner with you on this very critical issue, and i yield back. Thank you very much, chairwoman maloney. Im sorry for the delay but it is a way to make sure each of us gets on mute and can hear us when we talk. Now i would like to turn it over to Ranking Member for your opening remarks. Unmute congressman cloud. Hello, can you hear me . , chairman for holding this meeting. It is certainly an important topic as we deal with a pandemic that has ravaged our nation and indeed the world. It is importantly come together and address these Health Issues intentionally. I would note off the top of that, we have the ability to hearings as opposed to briefings, hearings which would follow rules and i would request the majority considers future hearings, that we would conduct them in a format that would protect rights. Congress has provided 3 billion for vaccines, therapeutic, for covid19 through the cares act. The Trump Administration has our countryessly so can overcome the challenges and ensure we find the best therapeutic to treat covid19 and can develop a vaccine in record time. To this end, President Trump initiated operation warp speed, which empowered the government to work with the private sector to manufacture 3 million doses of the vaccine with the goal of having those by january 2021. President trump because of this immense effort that the government and pharmaceutical companies, the u. S. Is on track to have a vaccine available by 2021. D or early this is an incredible feat. In context, the h1n1 vaccine was developed in six months, but relied on 70 years of food flu Vaccine Research. It took eight years to develop an ebola vaccine. The American Public should rest assured the administration and Industry Partners are not sacrificing safety while developing this vaccine. Cornersnot be cutting in the development of this vaccine. Instead, operation warp speed enables steps in the vaccine process to happen simultaneously. It doesnt skip steps, but allows them to be done simultaneously. This increased the cost of production. Companies have partnered together on cost to get a vaccine faster. The federal government announced two new contracts. Both of these companies have agreed the doses manufactured under these products will be owned by the federal government, meaning if the vaccine is proven effective, the u. S. Government would make the dose is available to americans at no cost. Other Companies Like moderna, to astrazeneca have pledged set low prices on any vaccine approved. Between the low prices and existing programs, no one would go without a vaccine who wants one. Insuring equitable access to the vaccine once developed, the cdc has been working since april to develop a ranking system for distribution. Those serving on the front lines like medical professionals, those with underlying are likely and those to get the first doses, ensuring the most vulnerable are protected. I look forward to hearing from the panelists on how we can sure ensure the public trust. Thank you, chairman. I yield back. You so much, Ranking Member. At thiseat to have you hearing and i appreciate your remarks. I think we are much better off when everyone is participating and asking the tough questions, produces a real robust conversation so thank you. Et me turn to our briefers we have five witnesses. Im just going to quickly say toir names and turn it over. He doctors, dr. Schwartz start. Now going to you are recognized for five minutes. There is a timer on your screen and i appreciate all of us sticking to our five minutes, so with that, you are now recognized. Thank you. Can you hear me . Ill look for that timer, thanks. And morning, chairman members of the subcommittee. For the work you have already done to ensure the response to the covid19 pandemic is done with the best science and the scientists. I am the president of globalization at the Vaccine Institute in washington. Make vaccines to more accessible and expanding across the globe. My entire career has been vaccine focused and for 15 years as director of the National Vaccine program. Familiar with the statistics. The virus has taken a disproportionate number of american lives and beyond the obvious health impacts, no while has been spared and the various efforts to flatten the curve, social distancing, handwashing are all important to help control the virus, it is absolutely clear the only population wide immunity will dampen the ongoing spread and the pandemic. Let me repeat. Immunitylation wide will stop the spread of covid19 and the pandemic. There has beend, an unprecedented effort to deploy vaccines for the u. S. Population and around the globe. This is extraordinary and marked by innovation and speed. Is focus of todays briefing how we insure all of this results in vaccines that are safe and effective. In addition to good science, i suggest there are three crucial elements fundamental to the success of this effort. No shortcuts, transparency, and trust. Let me elaborate. The development of successful human vaccines from idea to licensure is a complex prices, but a number of steps have arte been taken already been taken. Timelines without sacrificing safety. The fda is to be commended for a detailed guidance document on the development of a vaccine. These, there is pressure at work speed , may be well intended, may have misguided desire to shorten timelines. Shortchangeuld the process and such a misstep here would have serious applications, not only the risk that people will decline vaccination, but the trust of the American People in the process weve come to discuss. A poll found only half the Adult Population would take the covid19 vaccine. A third arent sure and one in five said absolutely not. These results are a window into the confidence the American Public has about this process. In 1972, Congress Passed the advisory act, committees were the best effort to provide their independent advice to the government and these meetings are open to the public. Transparency is an important element and i fully recommend any vaccine being considered for approval by the fda be reviewed by ann Public MeetingsAdvisory Committee. Ensurerticipant, i can the robust discussions they would have. Without such a public review, i stories will appear about closed doors because the government didnt want the public to see what may have influence the decisions. Those stories are impossible to stop and the best antidote would be sunshine. While we are here to talk about the processes to make a vaccine safe and effective, we should acknowledge we are here to talk about trust. Trust in the Research Process that leads to licensures, trust in a policy process by which vaccines are recommended. Trust in the providers who recommend vaccines to patients and trust that once vaccines are used through the population, there is a system that continues to assess their effectiveness. End, americans want to understand the process and to be assured the process is being followed and not shortcircuited. To build the trust that has been eroding over vaccinations for some time so when they come to weigh their decision about risks, they will choose to be vaccinated when it becomes available. Ive no doubt when a vaccine is available, the Vaccination Campaign in the u. S. Will be visible to all americans and given some of the frustrations and delays, critical elements of the response to date, lets not repeat that pattern. It is not too late to put a plan in place and communicate to all who need to know. People are tired of hearing we are building the ship we are sailing. But spilled it and sale it, no one wants it to sink. Guardrails to ensure a safe compliance with rules, compliance alone will not ensure a Successful Campaign that will end the pandemic. It must be transparent in the development process. There can be no shortcuts and amongmust be built developers, the government, and the public. Thank you. Dr. Gellin thank you rep. Krishnamoorthi thank you, dr. Gellin. Can you hear me now . Good morning, chairman and other Committee Members. Im a professor at georgetown. I was formally fdas chief scientist and have helped lead Public Health responses. Center forthe fdas evaluation and research, the center that monitors vaccines for use. I appreciate the opportunity to be here today. Health measures, diagnostic treatments can save lives but only vaccines offer the potential to provide widespread immunity and stop the outbreak before it burns through the worlds population. For this reason, there are efforts to accelerate Vaccine Development that weve heard about. Vaccine development and manufacturing are complex. Success is never assured and while we can speed the process, we must not cut corners and insure any vaccines are safe and effective and maintain public trust, which is already tarnished. So, fdas independence should be protected and the agency must uphold transparency about it scientific decisionmaking. In an article, colleagues and i outlined four safeguards needed for covid19 vaccine developed. We need strong evidence of effectiveness, best accomplished in Clinical Trials involving thousands of individuals, comparing rates of illness. In vaccinated and control groups to ensure vaccines work, you diverse most populations as well as elderly and those with chronic conditions. Fda recently published guidance a vaccine should be at least 50 effective as a reasonable starting point. It is born to emphasize effectiveness is not a given as it has not been easy to make vaccines against other coronaviruses. We need strong evidence of safety. Given to theents 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 candidates are based on novel technologies not yet utilized in approved vaccines. To ensure the benefits outweigh risks, safety databases should include several thousand individuals. Once safety is documented, studies should move ahead in pregnant women given the risk they face and the roles in health care and other essential workforces. To be thoughtful about Vaccine Access prior to approval. There may be circumstances where an unapproved vaccine could be appropriate in a severe outbreak. Safetyne with documented were available, fda can provide access to expanded Access Program or to an emergency use authorization. Eua are designed for flexible responses in health emergenciess but have an evidence requirement longer than the fdas normal standard. Andproduct may be effective the known benefits outweigh the risks. Experience has shown the public may interpreted as the same as approval. If a vaccine under eua raises safety concerns and users are unclear it was unapproved, a price crisis could occur. Therefore, if a vaccine is used before approval, we suggest informed consent be part of the process even under a eua and this be targeted to those at higher risk of complication. Finally, a Monitoring System to track safety. Be detected in preapproval studies and a vaccine is administered, common events will occur after vaccination but it is critical to be assured they are not vaccine related. H1 vaccines, the system, tracked millions of doses. Vaccines were safe. We need systems in place now, not later. For transparency about how safety will be monitored and communicated. In conclusion, while working to get vaccines quickly, the safeguards ensure they will be effective, and trusted. Thank you and i look forward to the discussion. Rep. Krishnamoorthi thank you, dr. Goodman. Next, have i pronounce your name properly . Yes, you have. Rep. Krishnamoorthi you are recognized for five minutes. Thank you and good morning, mr. Chairman. I am a pediatrician trained in Infectious Diseases and a professor at Bloomberg School of Public Health were i lead the center for immune is a sure research and the vaccine initiative. My work is focused on respiratory virus vaccines and vaccine ethics. With respect to covid19 on the vaccine trial and will likely be a coinvestigator for two other vaccine trials scheduled to begin this summer. Ive also had the honor and privilege of serving him to federal Advisory Committees. I served as chair and on acip. Americans3 million sarsbeen infected with covid two and more than 137,000 have died. This virus has profoundly butcted affected us all, especially for the elderly, poor, and racial and ethnic minorities. Development and deployment of vaccines is essential. Vaccines will be our best tool to control and ultimately end this pandemic. This is not a competition, but a yes and moment. Testing multiple vaccines now will increase the chances that we will have effective vaccines in sufficient quantity to protect people in our country and worldwide. We need to make sure the populations are included in vaccine trial so we have the safety and ephesus he efficacy data to inform decisions about authorization. Plan for the careful, open, transparent evaluation of all child data so we can use these vaccines effectively to protect all members of our society. Advice will be critical as the data anded reviews makes decisions about licensure. Childhood that a conditions. For licensure are two important purposes. Fda have concerns about some of our countrys leading independent vaccine scientists. Equally important, the fda has the opportunity to hear and respond to the publics concerns in a public forum. Safety and efficacy data will be emerging from covid19 vaccine trials. As dr. Goodman described, decisions may need to be made s for vaccineseua that are promising or incomplete. Questions about risks, benefits for entire populations or high risk groups must be discussed using all available data with clear acknowledgment of what is known and what is yet unknown. Decisions about licensure must be made with engagement, review, and advice. We also need to make sure vaccine safety and efficacy information reviewed is representative of society, which means trials must include geographic, and age groups. We need to ensure black, latinx, and native american populations who are far more likely to be infected and die from covid, have opportunities to participate in the trials but choose to. For this to happen, we must acknowledge the high level of andrust in many communities work urgently to engage communities to build trust and insure the vaccine will be free and readily available. We must also have a clear plan to meet the needs of pregnant women. The recent cdc report indicates