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,