So concerned about flu season, about children not getting , not justight now with the Covid Vaccine, but other childhood vaccines that we are seeing a decrease in the numbers. What are your recommendations for how we implement a better strategy in making sure that we are tracking flu and covid, and also getting children, making sure they continue to get vaccinated . Dr. Gayle . Dr. Gayle we really need to build on the existing programs that we have. We have such a strong system for childhood vaccinations that needs to continue to be strengthened. It also, as was mentioned in several other questions and by other panelists, we have got to restore the trust and confidence that has been eroded in vaccines. I think those two things for me are essential. Build on the systems that we know work, get the right information out, and continue to build on the messages on why it really makes a difference to have children vaccinated, and build on those systems that we know work. In my 15 seconds. Dr. Offit initially, what happens, because of the pandemic, there was a dramatic decrease in childhood vaccinations, as reported by the report. That started to,. People are more comfortable going to the doctors office, but you are right, we need to make sure we get a flu vaccine coming into this winter. I got my flu vaccine. Thank you. I yield back. Thank you. Chair now recognizes miss custer for five minutes. Thank you for this hearing. This is bipartisan. I got my flu vaccine as well. We are not trying to politicize. The president of the United States has politicized this vaccine coming just weeks before an election. We owe it to the American People to explain the process and the system and the transparency in the hopes that one of these multiple vaccine candidates will be proven safe and effective. That will be only half the battle. Once we have unapproved vaccine, we still face the formidable challenge of distributing hundreds of millions of doses around the country. This will be an unprecedented effort and we need to start preparations right now. Of then, what are some essential Lessons Learned from past Vaccination Programs, such , regarding thec novel use of a vaccine . Dr. Khan thank you, congresswoman kuster. I think it starts with appropriate messaging. Under promise, overdeliver, make sure we have excellent planning at all levels, local, national, state level, tribal and territorial level. Make sure we have prioritization. Not be enoughwill vaccine the moment it is released. That needs to be clear up front. Part of the planning needs to deal with the logistics. This is going to be logistically extremely difficult, unlike the h1n1 pandemic in 2009. In the end, there was only a need for one dose. In this case, you need two doses of the exact same vaccine 2128 days apart, which will be problematic. There is complex requirements for storing these vaccines. Depending on what the size of the orders are, those may need to be split up and sent to various places in rural areas. We talked about mass vaccination but we need to be careful about what the word mass means. You dont want hundreds of people gathered together. We would like to keep those two pieces apart, the infection and protection. There is going to be significant challenges throughout the system. I did not even get into the data systems. I was going to ask you further about one of the challenges with the Vaccination Program on this scale is data systems to track about distribution and schedule immunizations, especially if they need two separate doses. What should congress be insuring to make sure that we have good data on a Vaccination Program . Dr. Khan how do we strengthen the systems that are going to have to Work Together in terms of vaccine tracking, immunization registries in the state, the vaccine adverse Event Systems . There are three systems. How do you make sure those are working, robust, interoperable and will give you the data in realtime that you will need to where isat not just the vaccine being distributed, but actually giving it to people and what the side effects are . Out,vaccine is getting make sure that we are being equitable in the distribution. Thats only going to be determined by data. Is our existing Health Infrastructure adequate to meet the storage and Transportation Needs for national and equitable distribution, including rural communities, communities of color that have been disproportionately hit by the covid19 pandemic . And then, distributing a global vaccine will require extensive air travel via cargo flights. Do we have the workforce and capacity to achieve this logistical feat . Dr. Khan i think the one thing that does worry me is the requirement for at least one of the messenger rna vaccines to be shipped and stored at 70, 80 centigrade, which would require at least dry ice constantly being used. They are doing studies where i am sure the company has been very good about making sure there is no historical precedent for us maintaining vaccines on dry ice in the United States, thats never happened. I do worry about that. I think it will be an in normas challenge enormous challenge. Thank you, madam chair. I do appreciate holding this hearing, although i am concerned by the fact that everybody keeps bringing up not to politicize it, the administration is politicizing and. Thats exactly what this hearing is, we are politicizing it. Me you constituent tell can tell when a Natural Disaster or a nationals disaster is serious is when republicans and democrats are both on the same page. When we start politicizing it, it becomes less series. Thats exactly what we are doing here. We have members on this panel that are extremely biased towards the president. That alone drives down the confidence of the American People. Do they really need it . Is it really that serious . If you are in one of the vulnerable positions you need to get the vaccine when its available, not worrying about if the president brought it out too fast. Do we really think the pharmaceutical companies or the fda would allow that to happen . It is their name. They are the ones trying to get it to the American People to save lives. The more we question it, why underneath the disguise of trying to say we are trying to keep the American People safe, the more we can actually cost peoples lives. We need to be very careful about that. Everyone of us have a responsibility to the American People enter the public, regardless of if youre a witness or a member here. You yourself can be driving down the confidence of the American People. , ih that said, dr. Mcclellan would like to talk to you real quickly about the pharmaceutical companies and the vaccine. Do you think that the companies would knowingly produce a vaccine that is unsafe for the public . Dr. Khan no dr. Mcclellan no, representative, i dont think so. They have affirmed the same thing in writing and they are affirming it by following the fdas guidance on how to conduct the development, the Clinical Trials, and making sure they are doing safe manufacturing. Under President Trumps administration, do you think the pharmaceutical companies or the fda are cutting any corners and developing the Covid Vaccine . Dr. Mcclellan the warp speed process is happening much faster and i know that makes people nervous. Its important to recognize that fda is firewalled off even from warp speed. The work they are doing in supporting these very large trials and an unprecedented pace is different from the review that is going on independently by fda. It is sort of like independent oversight within this very accelerated process to make sure that we are not cutting corners on the safety and effectiveness. Panelistsny other like to add to that . Ok. If not, we will go on then. Thate you confident then when a vaccine is authorized, that it will be saved to the public. The other former fda commissioners, the group all stated their confidence in the fda process as well. We have heard that from dr. Tony fauci, dr. Francis collins, from other Public Health leaders in and out of the administration. Thank you so much. I dont have anything else. Thank you. The chair now recognizes congresswoman castor for five minutes. Thank you chairwoman for having this very important hearing today on how we can ensure a safe and effective Covid Vaccine, covid19 vaccine. The experts have been direct and straightforward and simply outstanding, very helpful. You simply cant to gloss over the fact that the administrations Public Health response to covid19 has been weak and overly politicized. D ahas cost lives, cause lot of pain. The importance of developing a safe and effective vaccine is paramount. Once a vaccine is approved, we will face the daunting task of distributing it across the country. For that effort to be successful, everyone must Work Together, federal agencies, states, territories, local and tribal communities and our public out agencies. I asked thehearing, vaccine manufacturers about the importance of our state and local Public Health professionals in Vaccine Distribution. Local,l agreed that our trusted Public Health agencies are critical to successful dissolution. Across americas are very diverse and covid has laid bare many weaknesses in our longestablished public Health Infrastructure. It will be more critical than ever that our state and local Public Health professionals are empowered to implement an effective and timely Vaccine Distribution. You point to this infrastructure as a key component of a successful covid19 Vaccine Distribution and uptake, stating that we canleverage our nations existing Vaccine Distribution infrastructure to ensure efficient and equitable aspects to covid19 vaccine. As thele will they play partners for effective distribution . And do you want to highlight any weaknesses in that infrastructure now for us to address . You, congressman castor. We dont need a vaccine. Fromow from experience china, vietnam, thailand, new zealand, taiwan that you can get pretty much to zero cases based on good Public Health practices. Those would be the cdc guidelines that i discussed previously and guidance. We know a vaccine is critical and will help her do this but we know we can do this without a vaccine with the Public Health tools that we have today if you want to. Critical to make that happen is that we have strong state and local, tribal and territorial infrastructure to do what needs to be done. To ensure Community Engagement around wearing masks, social distancing, and handwashing. Dr. Offit and others have highlighted why it will be more difficult than what we have done for example in 2009. Do they have the people necessary to do all of this . This is not just that epidemiologists. It is the epidemiologists, health communication, laboratory people, publichealth advisors. It is a core of people that we need to make sure that we have to ensure that this vaccine is wellplanned, can get out as it needs to get out within our communities. Rep. Degette what is your view . You have devoted your lifes work to publichealth and boosting our trusted authorities and that infrastructure. What do we need to be focused on right now . What we really need to do is to make sure that we make it possible for the systems that we know have delivered for decades and decades have what they need to be successful. So, all of the things that people have already talked about around building those systems starts with building the confidence in those systems, adequately funding those systems, making sure that we have the personal, and then making sure that we have the data systems in place that are going to be so important for continuing to track the distribution. Also, i think rep. Degette im afraid, because i have watched in my home state of florida over the past decade, or the Public Health agencies, they have let them wither on the vine. We dont have the same kind of infrastructure in place. What can we do about that . part of it starts with having the right kind of National Leadership in place. It has always been important that we have a strong cdc, that the other agencies that are involved in the immunization programs are fully funded, have the support that they need, so it starts with national guidelines. National you have to have those systems in place, with the national guidelines, infrastructure, and make sure that those are then being partnered with state, local, and territorial leaders who really are the ones who can get to the people and make sure that these programs are implemented. It takes having that whole system. You cant have these fragmented systems. You need the whole system working in tandem. Thank you very much. Rep. Degette chair now recognizes mr. Duncan for five minutes. Duncan a hearing entitled pathway to a vaccine ensuring a safe and effective vaccine people will trust has taken a lot of different paths today. It has been very interesting to hear the comments from my colleagues in congress, but also the panelists. Ans comments kh about we dont need a vaccine, we can do all these other things, and we are spending billions of dollars on development of a vaccine. I dont disagree with him i believe in. Herd immunity, taking those necessary steps. We can probably eliminate a lot of folks catching the flu, yet we push a flu vaccine every year. Its just kind of interesting to hear the banter back and forth. We talked about how this thing, you are not tried to politicize it, but you are doing exactly that, not pointing out that the president said this, that, on the other. The president is a Real Estate Developer and businessmen who had to rely on the cdc experts to give him the advice. They have been all over the board. If they are advising the president and he seems to be all over the board, it is because of the advice he has been given by nonpartisan members of the cdc. And other organizations that advise him. Mcclellan, your. Know, i understand that fda vaccines and related biological products Advisory Committee, an government form of and pharmaceutical companies, they review and a bill you wait and evaluate data on vaccines. Why should the American People have confidence that this committee will provide unbiased recommendations regarding a covid19 vaccine to the fda commissioner when we have seen so much partisan rhetoric from all fronts, not just my colleagues, but really the media and other groups . How can we have confidence that this committee will provide unbiased recommendations . Dr. Mcclellan i have a lot of confidence in the committee. It goes from my own experience. I was fda commissioner, not at a of this level publichealth emergency. The agency is used to getting pressure and different views, both political pressures and from scientists, who sometimes have different views and interpretations of the evidence as well. The evidence evolves over time. What we thought might be the best answer in february is not rep. Duncan let me stop you right there, dr. Mcclellan. You just said this was, i know coronavirus. El we are learning things about the virus from the time it came on the scene in january until today. Things that we learn, we shift course, right . They are saying the president has lied to the American People, basically shifted course based on the knowledge of the virus. Would that not be fair to say . Dr. Mcclellan do i trust the Advisory Committee . I trust that they will bring all this information together and oversightas expert and experience to enable fda to make an informed decision that reflects all the science. That is a process we should have a lot of confidence in. Let me talk to dr. Offit. There was a question on how they would create a vaccine and affective for the most vulnerable the population. We know who the most vulnerable are. Did, youerview you stated regarding individuals in the 65 and up age group, i cant would ever allow a vaccine to be recommended for that Group Without having adequate data. Do you stand by that Statement Today . Dr. Offit sure. I am on the fdas vaccine Advisory Committee. I can tell you how we operate. We operate as scientists. Thats what we are. Politics does not enter that at all. Do you think dr. Fauci has operated as a scientist . Dr. Offit absolutely. I think dr. Collins and dr. Redfield have operated as scientists. Thats what i think. Duncan dr. Offit i believe they have operated as scientists. We learn more and more about the has beenit evident the publishing. As the data comes in, remedies and other things will change. Dr. Offit you always learn as you go. You always have to be openminded. What do we know . We know that masks work. Even though you will have rose garden meetings or these rallies where everybody is inside not wearing a mask. Rep. Duncan what about protests . Dr. Offit convalescent plasma has no evidence that it worked, but it was push. I dont understand why we are having this meeting. We should not need this meeting. We dont trust the fda largely because of what has happened with the administration pushing the fda to do things it shouldnt be doing. Thats why people are upset about this. [crosstalk] thanks, madam chair. Can you hear me . Good. Rep. Degette i can hear you, yes. I want to return to a topic that has been touched on because i am very concerned about this declining confidence we see in the public when it comes to the Covid Vaccine that we are working on. We have seen that confidence decline over the last few months. Retty precipitously i in a pew survey, only 51 of u. S. Adults now would get a vaccine if one were available. Thats down from 72 in may. A Kaiser FamilyFoundation Poll found that 60 62 of americans worry that political pressure from the Trump Administration will lead fda to rush in its approval of a vaccine without making sure that it is safe and effective. So thats not a good situation to be in. Its very alarming, as we are trying to tackle this pandemic. In your testimony, you emphasized trust of the vaccine will be as important, if not more so, than safety and efficacy. Thats a pretty powerful statement. I wonder if you could elaborate on it . You always think efficacy and safety are rated at the top of the list, but you are saying you have to put trust up there, or else it will not be effective. Dr. Khan i will give you two specific examples. The first was with the h1n1 outbreak in 2009. Individuals failed to get vaccines when they thought they were supposed to get, in the end , i believe only about 27 of americans get vaccinated. We did not vaccinate as Many Americans as we would have wanted for h1n1 because of this mistrust in what they were being told. The second example is for highly efficacious lyme vaccine that was taken off the market, not because of any concern about efficacy or side effects, but and efficacyeived and side effects efficacy and side effects. It was pulled off the market. Trust was really critical to allow us to get to the vaccine coverages we would have liked. Howou are pointing to tenuous this trust can be with the public and how careful we have to be in the process in convey that sense of comfort and safety and efficacy that will allow people to take advantage of this opportunity when it presents. Thats whats really at stake here. I think its cause for real concern. You said in your testimony, the administrations arization of science causedization of science some to wonder whether the same low standards would be applied to covid a Covid Vaccine. Answer this for me. We could go a long way towards restoring trust, could we not, if the president , if the administration, the political people, in other words, not the Public Health experts, but the political folks who operate in this space, beginning with the president , who is, you know, leading the executive branch, if they would align themselves with publichealth experts and follow them . It doesnt mean you dont watch over the process. It doesnt mean you dont kick the tires and make sure it is being vetted properly. You could convey broadly your view that the Public Health experts, the scientists, the people that are most knowledgeable in this field are the ones that are going to call the shots. Quickly, ift very that was the posture the president and the administration took, couldnt that be to restore trust in a meaningful way . Could you speak to that . Absolutely. People look to the president for leadership. Other countries have done much better on getting on top of this pandemic. We havent. The biggest reason is that hygienic matters. It is more powerful than vaccines. A couple weeks ago at childrens hospital, philadelphia hospital now loaded with children who have covid19, if you give me the choice of a mask or vaccine, i would choose the mask every time. It is such an important, powerful to. I think the president could do so much to promote that and he doesnt. I grew up in baltimore, maryland. Huge fan of your father. I would just say that if you are fighting with the Public Health experts, you are politicizing this. If youre aligning yourself with them, your depoliticizing it. I yields back. Do we have mr. Burgess on the phone . I dont see him. Going once, going twice. Mr. Peters, i will recognize you for five minutes. Sorry about that. Would just offer a lot the questions have been answered, but just to follow along, i guthrieu and mr. Deserve credit for putting on this hearing. The idea that it not be political. I think to even throw a bone to administration, i like the idea of the way that dr. Fauci has characterized this warp speed effort. , is tofort, by the way accelerate manufacturing once a safe vaccine is developed. He has emphasized over and over again that the risk we are taking is a financial risk. I think that is totally appropriate. Once you have that formulation, that you would be able to hurry up in making it available. I think that makes all the sense in the world. I think it is important for all of us, and you may call this political. If anything you say against President Trump is necessarily political, then it is blue. You cant set a date for this vaccine to be safe. That is something that has to follow through the process of that we have developed over many years and which we are not just lucky to have, but we are smart to have in our country to develop these vaccines. We have the confidence that our public Health Infrastructure, from research to industry, can come up with a vaccine. I think we all believe that thats true. We would maybe like to see a one does vaccine, but in any event, i dont think its inappropriate to call about any politician who suggests that that time i should be modified to fit a political schedule. I would just say that i appreciate the testimony of the witnesses and i wheeled back i will yield back. Agree with your comments. Clark on the. Phone . Oh, there she is. Your recognize for fiveminute. Rep. Clark thank you so much, madam chair. I have been listening attentively at so much and so much of the concerns we have have been responded to. I want to raise the issue, being a new yorker who was at the ,picenter of this outbreak around things that we can do to how wedrill down on continue to protect ourselves. I am concerned about the mixed messaging around the publichealth protocols that have been working in tandem with our awaiting of the vaccine. We know that todays hearing focuses on what much of the world is eagerly anticipating, the approval of a safe and effective vaccine for covid19. We are all rooting for that, but we all must keep in mind the bigger picture. Publichealth experts have been warning for months that an eventual vaccine, while critical, will not be a Silver Bullet that instantly kills off this pandemic. I really want us to drill back home with the American People when i see there being some retreating from the initial protocols that have brought new york city down to record lows. We are beginning to see small ticks. Up it is because, i believe, people are beginning to relax around those publichealth protocols. We can all agree that a vaccine will be a critical tool in this fight. Why wont this be like flipping the switch . Will a vaccine alone be enough to stamp out this virus . Or will we need to rely on other Public Health measures to some extent . Thank you for that critical question. Of course, we all wish it would be like a light switch that we can flip on and move forward. There are several reasons why it wont be that way. Even under the most optimistic scenarios, i do not expect a vaccine to be 98 or 100 effective. If it is 70 or 80 effective, that would be terrific. There is so little we know about what will happen after you are vaccinated, about your ability to transmit to others. It may be that you are vaccinated, you may be protected but still able to transmit to others. It is on highly unlikely that 95 of americans will get vaccinated. A lot people wont take this. 70 of americans get be vaccine, which would wonderful and 70 efficacy, that does not get you population level everything is done. It will be immensely helpful. It will allow much of our lives back. There will be some highrisk things that we will continue to manage very effectively. We will have to continue to avoid large, indoor gatherings without masks. A lot the things we care most about, schools and work, a lot of people a lot of that will be possible again. It is not a Silver Bullet. 2023, we will2, still be dealing with this virus but hopefully much better off than we are today. , we cannot you state wait for a vaccine to contain this outbreak. We must use the publichealth tools we already have available. How does a vaccine fit into the larger Public Health strategy for fighting covert 19 vaccine covid19 vaccine if it will not be Silver Bullet and instantly end the pandemic . To unmute. Ou have dr. Khan thank you. The doctor has stated why a vaccine itself is not sufficient. Vaccine needs to sit on top of a publichealth response. We know that this publichealth response can contain disease from experiences in a not just now multiple countries, but what we saw in new york and what we are seeing in a lot of the northeast. We know these publichealth measures to make a difference. Know what the controlled is. The first is integrated, coordinated, local, state, and National Leadership that is evidencebased, consistent messaging, looking at metrics. Number one is leadership. Number two is drive down community transmission. Increase Community Engagement. That is masks, handwashing, social distancing. Number four, which we are doing a very good job at, is decreased deaths amongst people who unfortunately still get infected. Our Case Management has markedly improved. Haveherapeutic options markedly improved. Those are the four things that we need to do. We still have not fully implemented those in the United States yet, which is why we see day, and why we cannot wait for a vaccine to down to zeroaths or as close to zero as we can get. After having to experience what i did in new york city, it pains me to see the rest of the nation going through what it is going through. They have not learned from our experience, and what we have done to keep our curve flat. I hope that this discussion today in collaboration with the vaccine will really provide a parts ofroadmap for the nation that are still struggling with the answer to keeping americans safe. I yelled back. Thank you so much. Of the members of the subcommittee have asked their questions. I am pleased that we are joined by several members of the full committee. I am going to start with congressman carter. Your recognize for five and its you are recognized for five minutes. Thank you for allowing me to participate. As a practicing pharmacist over 30 years, confidence was extremely important. , an i recommended a product overthecounter product to a patient, it was important for me to be confident and to exude confidence that this was going to work for that patient. That, we spent a lot of time today talking about the politicizing, if you will, of this hall vaccine and this whole process. As a health care professional, as a pharmacist, i find it irresponsible that members of congress would be doing this. This is something that we show all be together on. I have dealt with the fda, i have seen the process work. I have seen products that went all the way up to the fourth stage and then were not allowed to go any farther. Ive seen that happen. Up confidence in me in knowing that the process works. That is all i am going to say about politicizing this ordeal. I want to talk about distribution of this, and making sure that we have a process in criticalecifically the aspect of allowing pharmacist to be able to administer this vaccine. Dr. Mcclellan, i want to ask you, 95 of all americans live within five miles of a pharmacy. Pharmacist ares the most Accessible Health care professionals in america. In order to make sure that when we get this vaccine safe and effective and when it is out there, and we are going to make sure that it gets out, would you agree that pharmacists need to be able to administer this covid19 vaccine . Dr. Mcclellan i agree. We have got experience in the pandemic of pharmacists playing a Critical Role in access to testing and helping people respond more quickly, get greater access there in helping with flu vaccines and other issues that also play into the pandemic, as we talked about already today. They are also an important part of that trust. People still trust their health professionals, doctors, pharmacists, even if its gone down for fda unfortunately. Thats another check on making sure we will have an effective vaccine that can be brought to the public. Pharmacists have a Critical Role to play in this. One of my favorite stories is the fact that i went from being a pharmacist to being a congressman, the second least trusted profession in america. The point im trying to make is that it is important for pharmacists to be able to administer that. Weve got a situation where a lot of the states have authorized it, but we need a blanket policy, if you will, so that we can have all pharmacists, whether it be independent retail or chain retail, to be able to administer this to get it out quickly. You are a former cms administrator. I wanted to ask you, you are aware of the issues that deal with pharmacists getting reimbursed and being able to bill medicare for these types of things. This has led to a lot of problems. Right now, we are trying to get a temporary pharmacist provider status so that pharmacists will be able to get reimbursed for administering these vaccines. Obviously, we have got to have insurance, coverage, everything that we should have in order to administer these vaccines. That is something we have been working with cms with in trying to get that done. Do you agree that congress should grant temporary authorizations for pharmacists provider status to be able to administer this vaccine . Dr. Mcclellan if thats what it comes to. Cms has authority to expand the scope of practice and coverage, any Public Health emergency. We did that in circumstances like an hurricane katrina. Edentsare some prec for handling this. There seems to be broad agreement around the fdas process of approval to make the vaccine available. We all have work to do together on the distribution and access to the vaccine, where that depends a lot on, you know, i would love to see more activity at the state and local level focusing on that, since we do have a good program in place for the safety of the vaccine itself. Rep. Carter again, this is not a partisan issue with pharmacists being able to be granted provider status in order to distribute and administer these vaccines. I would solicit your help as well as my colleagues on the other cited the isle as well as myne on this Committee Colleagues on the others of the aisle as well as everyone on thank you,tee, and i and i yield back. Youve raised an excellent point. Millions of americans get their flu shots right now at workacies, so we would together with you on that. I would like to recognize ms. Dingle for five minutes. Representative dingell thank you, madam chair. I would like to tell my colleague from georgia, when we know the vaccine is safe, i trust distribution capacity. Aboutne has been talking all day, both witnesses and members, about ensuring any potential vaccine is safe and effective and making sure it is available is going to be critical when we know it is safe. Committees the constructive role in helping shed light on the challenge we face. Noted in your testimony that while we sometimes accepted potential a certain level of ential harm, it seems like i believe weve lost [indiscernible] can you hear me . Yes, we can hear you now. I believe i have the gist of the question [indiscernible] you point out, was [no audio] hear me . . You know what he thinks he gets the gist of your question, so we will go ahead and have an answer. The question is really important, and this is an important point i think the American People need to understand, that we do use a different bar for using emergency youth authorization for therapy because these are for sick people who otherwise might die and you have a lower threshold for what you would call effectiveness and when you give vaccines, youre giving it to Healthy People. Protect Healthy People by having people wear masks, by doing social distancing, by all the things we know about, so you have to have a relatively high bar for the authorizing of vaccines. This is a basic principle of medicine, first do no harm. You have to have clear evidence you will do much more good than harm to that person when you intervene medically. That is one reason why we all have said this, and the processes of the fda around vaccines have acknowledge this and i think have been built around it, but it has been really critical to all of us those processes be followed in the covid19 Vaccine Development and approval. I am not an antivax or so ie make that clear did have [no audio] you are frozen again. Representative dingell ill yield back. all members can submit questions for the panelists in writing, so we can have you do that. The chair now recognizes mr. Bill ruckus if he is still with us. I see he is sitting down. [indiscernible]. You need to unmute where did he go . Ok, weve lost mr. Bella rock us, so im going to recognize mr. Ohalloran for five minutes. Ohalloran thank you and thank you to the panel for all the information they put forward this morning on this afternoon. Over the past six months, this committee has held multiple hearings featuring Public Health experts and officials as well as witnesses from pharmaceutical Companies Involved in development and manufacturing of the vaccine while discussing the Public Health response to the coronavirus pandemic. Through the cares act and as we madeseen the government significant investments in a bipartisan way in the private sector to manufacture and scale a vaccine to protect americans from the coronavirus. Ofly reports on developments vaccine are promising. The release of an effective vaccine to market will mark a milestone and serve as an to finallyeapon defeating a public of crisis, but americans are confused. A Pew Research Center poll released just two weeks ago showed that only 51 of americans, adults, would definitely or probably get a covid19 vaccine if it were available today. These members represent a 21 drop from survey numbers released in may. This has the potential to be of massive concern. I also want to address the issue of what this means to development of future vaccines and future medicines as we go injectingh of politics into this process. And is about scientists researchers and process as it has been for many decades. We need much transparency from vaccine train your vaccine manufacturers, Public Health agencies like fcc and nih, so the public knows the vigor and scientific discovery going into these products. Unfortunately, we are seeing the current process has cast doubts healthapolitical public agencies. We need clear and straightforward information from our leaders to ensure that americans are vaccinated when these products are brought to market. Further communication is also needed from pharmaceutical companies. Andr role is critical, their business depends on public vaccines work as intended. The American People need unprecedented transparency from tormaceutical companies explain what various trial stages mean, what the side effects are and eventually when a vaccine is approved, are there may be given the drug, are they compromised in any way . This first vaccine will hopefully not be the last vaccine and hopefully will not be the only vaccine. Can you talk about how political intrusions into Vaccine Development process are harming Americans Trust in our Public Officials and Public Health agency . And importantly, how this will be undermining the importance of americans being able to be safe andd when a effective vaccine is approved . Thank you. Thank you for that very important question. The bottom line is that so far, the scientific integrity of the process has been superb. Really worldclass scientists working in the private sector, working with nih to do what i think is an unbelievable job in bringing a vaccine forward in record time of the problem is that when i speak to people working on the Clinical Trials, they cannot give me a date. They dont know when a vaccine is going to be ready. There are processes for looking at the data. There are independent boards that are going to be different. What we all want is we all want a vaccine yesterday, but we want a vaccine that is going to be effective and weve got to let the science lay that process out, and it makes me very anxious when i hear ceos of companies who technically dont have access to the data or political leaders who are picking specific dates and saying we will have a vaccine by a specific date. I know they dont know what they are talking about. But it makes the American People deeply concerned because they safeguardsall of the , and we all worry those will be undermined. What ive been asking is for politicians to basically be quiet, to knock it off, to stop talking about dates. Let the scientific process move forward. Scientists will declare based on scientific principles that the vaccine is ready for authorization and eventually approval, and not a day before that, unfortunately. Thank you. I yield. Thank you so much. S, you have the last word. Representative bill rockets thank you, madam chair. We had some technical issues before. Thank you for giving me the time. I understand youre here in your capacity with the national academy, but given the importance of enrolling diverse populations in largescale covid19 Clinical Trials, i wanted to ask if your organization, the Chicago Community trust, has undertaken any efforts to promote and encourage participation in Clinical Trials among racial and ethnic minorities, and if so, would you be able to share the details of those efforts . Thank you so much for your question. I would just say here in chicago, we have an Outstanding Department of Public Health that has really wonderful relationships with the community. We continue to work with them. We have had a really close relationship with them throughout this pandemic and we will continue to work with our department of Public Health to make sure that these efforts actually serve all people. We dont have specific details, but just to say this is something we here in chicago feel is incredibly important, and we always put Health Equity at the center of the work we do in Public Health. We will stand by our Public Health department and make sure that we can be part of making vaccine is safe and available in an equitable fashion and our guidelines we are talking about in this hearing put a real focus on equity and on Mitigating Health inequities because we know there has that has been so much a part of the pandemic that highlighted the longstanding Health Disparities that exist in this country among people of color, so this is going to continue to be a big focus for us as an organization, and clearly, it is something highlighted in our report. Thank you. Out how can we reach out tell us how to reach out to communities and groups that are disproportionately affected by but have high rates of Vaccine Hesitancy, and who are the most effective messengers to these communities . I think this is so vitally important. Dr. Kohn dr. Kahn i would say you need to reach out to them for their concerns about covid19 affects people of color, their access to care, so that needs to be done by local and state health department, working with local community organizations, make sure you are engaging those organizations, including faithbased organizations in that work, so that is the good Community Engagement work you need to do, and as part of that work, you can help protect that Community Today with tools that are available to us. Please make sure you make yourself available for Contact Tracing if somebody calls. Please wear masks. Wash your hands, social distance. Working with the community not to decrease transmission, that will markedly increase the trust once the vaccine comes in to help all of our communities get vaccinated. Are you familiar with the Vaccine Hesitancy and Education Programs . If so, can these programs help increase Public Confidence and increase immunization rates . I think people who are hesitant about the vaccine are and skeptical about everything including vaccines. If you asked me if i would get a covid19 vaccine right now, i would say no, i want to see the data first. Is use what you do reason and logic and passion and compassion to try to explain those data, to frame those data in an emotional and human story that let people know that a isice not to get a vaccine not a risky choice. You have to explain, heres what we know. The vaccine is safe in 20,000 people. That does not mean it is safe in 20 million people. We know the vaccine is 75 effective, but we dont know how long it is effective. We will know that over time. The question is not if you know everything you dont know everything. The question is when you know enough and if you dont, how you will find out. I think there is a group and much Smaller Group i would call antivaccine activists, people i would largely call conspiracy theorists. As noted tyson says, if someone comes to a conclusion without using logic or reason, youre not going to talk them out of it using logic or reason, and i think that is the case here. I would say 85 of the people who are concerned about vaccines are reasonably concerned and can be i think talked down as long as you provide data and clear, compelling, and compassionate data. Thank you, gentlemen, and i want to thank all the witnesses. I think i can speak where everybody on both sides of the the integrity of the Research Process that weve had so far has been superb. We have the pharmaceutical working through operation warp speed, and we are hoping we will get a vaccine as quickly as possible, but that we really cannot i think as you and the other panelists said, we cannot force a timeline, and all of us just have to be ready to accept the timeline we hope its fast, but we cannot be saving dates. It includes not just meddling in the Research Process, but also announcing deadlines or reallyes before they are appropriate. I think it is imperative that we follow the contact. Its imperative the public has access, and thats what this hearing was about today. Pete frequent the, people ask me why we do oversight hearings. The reason is to shine a light because sunlight is the best disinfectant and we think the more we have experts like you coming and talking about the process and what we need to do that the more likelihood it is that we will have a process that will not be meddled with and that will produce not one but we safe and effective vaccines. I want to remind members that they have 10 Business Days to submit additional questions for the record to be answered by the witnesses who appear before the subcommittee looking at you, representative dingell and i also want to ask that representatives respond quickly to any such questions, should you receive any. E have some documents we have mr. Waldens request. Project, theve Clinical Trial protocols for four covid19 vaccine manufacturers. The letter signed by nine Drug Companies touting the safety of any covid 19 vaccine, the fda information on covid19, usta opinion dated september 10, 2018. We have the Washington Post opinion from seven former fda commissioners of the Trump Administration undermining the credibility of the fda dated september 9, 2020, which i offered, and we have the oxfam report on the worlds covid 19 vaccine supply dated september 17, 20 20. Objection, th heres a look at our live coverage, thursday, on cspan. The houses by canonical icam eastern for general speeches before turning to legislative business at 11 00. Members may consider a coronavirus economic aid package that provides another direct payment and funding for schools, small businesses, the airline industry, and covid19 testing. At 7 00 p. M. Eastern, our campaign 2020 coverage includes President Trump and joe biden speaking at the annual Alfred E SmithMemorial Foundation dinner. At pan two on