So, if there is no safety signal, if it is effective, we should say that absolutely loudly. If there is a safety signal and if its not as effective as we hope to say that also. I have very folk of his and the scientists that they will say what they find. While the data are produced by companies that are running the trials, the trials or under enormous amount of scrutiny, both by the fda and by the public. The guidance the fda put out that include a lot of this concerns other Committee Members have raised, including the representation of diverse populations, sample size, looking to safety signals. I believe, and again, maybe im being naive, but i dont think so. I think were going to see a lot of information. I hate to interrupt you but i want to make the point back when i was a very small child, i remember standing in line at my Elementary School with my mother to get the sugar cube for polio. I had friends that have polio, and im excited about what the possibilities can be, and i also feel that there are Many Companies that have agreed to donate millions of doses to the federal government for distribution. And i just want to see what is it to ensure that those doses are distributed for all americans across the country. And i think that operation warp speed is a step in that direction so that we dont have to fight over who gets the vaccine. Its potential if those doses if the vaccine works and is distributed widely, medicare covers it. Everyone in medicare gets it for free. Every person with Health Insurance would get it. So, i think there are mechanisms in place to allow this vaccines to thank you. I yield back. Thank you, congresswoman. I would now like to recognize ms. Tlaib. You have five minutes. Thank you. Yes, i know, im multitasking. Im so sorry. Thank you so much everyone for being on this call. I mean, i think one of the things i wanted to focus on and i thank the chairman for this, is to really talk about their effectiveness, right, and safety. As we all know is that it seems like its a good step towards some transparency and goal setting, but i think dr. Karron, i want to start with you with some of the basics. Will a successful vaccine, what will he successful vaccine to and how will that phase three trial make sure the vaccine does what it needs to do . Well, thank you very much for that question. I think that in the fda guidance , there are several possible outcomes, Outcome Measures that could be assessed. I think the most important thing for a vaccine to do is to prevent severe illness and death. And i think the fda guidance does speak to that and say that at minimum, must be a secondary outcome and could be considered as the primary outcome. Other outcomes that can be looked at, but in my personal view, are less important, are preventing any covid disease. Because i honestly think that even a vaccine that could prevent severe disease and death but still allows mild disease to occur would not be a failure. We would count that as a success. And what does the fda guidelines mean when this is a vaccine must be proven to be 50 more effective . 50 , it must have 50 efficacy. So, what that would mean is that somebody who is vaccinated would have 50 less chance of having a particular outcome, whatever outcome of the trial. And if i can, could i just make two comments about that . Because in some ways, many of our vaccines are 90 effective or 80 effective, and i think maybe the American Public might think 50 is a low number. But a couple of things to say about that. One is that, frequently what we see with vaccines is that theyre more effective against worse disease, so that a vaccine that is 50 effective against a mild disease might be even more effective against severe disease. And the other thing just to say is if we had a vaccine, if we had happened and death in this country that weve had from covid, that would still be a major accomplishment. So, you know, i dont know if you folks know, but the subcommittee wrote a letter to fda asked for a commitment to have 30,000 participants. We havent received a response yet, i believe, right . I dont think we received a response yet. One permanent part of a trial design is the number of participants, but the fda has been so desperate so what are the risks of having too many, or too few people in the Clinical Trial . And one of the things that dr. Collins and dr. Fauci endorsed phase three trials of at least 30,000 people. Do you agree with them that we need to hit the 30,000 mark . Im sorry, that question is to me or to no. Me. Those are great questions. I think that they were outlined well in the guidance. You heard from dr. Collins, as well. Reasons we talked about should 30,000 be the question . Should it be 30,000 . I think thats a pretty good number. Because thats going to allow us to look at some of these groups in the population. What we often see one of the things dr. Karron mentioned, some of the advisory committees is when the data comes through, while you wish you knew about some group and we need to go look at that. Setting that kind of marker makes to ensure you have evaluation each of the groups who receive this vaccine. I only have a little bit of time left. Dr. Karron, i saw the work you do on a vaccine for pregnant women. How important it to include pregnant women in these safety studies . Its critically important for some of the reasons i mentioned. Pregnant women, the data is still being gathered as to whether pregnant women have more disease than their nonpregnant counterparts. There are data from the cdc that suggest black and latino women may suffer more than other subpopulations of pregnant women. But at the very least, they dont have milder disease than other adults. So they deserve an opportunity to be vaccinated just like other segments of the population for population. Its really critical for support. Thank you both for your answers, and i yield the rest of my time, chairman. Thank you very much. Thank you so much. Can you hear me . Ok, great. Thank you so much, congressman tlaib. Now, we go to congressman connolly. Are you with us still . Can you see me . I cannot ah, we can see part of you. Here i am. Ok. Youre recognized for five minutes, my friend. Thank you, mr. Chairman. Thank you all for being here. I want to talk about two things, efficacy and risk. Dr. Goodman, how long does it take, historically, to develop an effective vaccine . Well, typically, as others have said, several year process. But what were seeing here dr. Goodman, i have five minutes to let me interrupt you. What is the fastest vaccine ever developed . Probably the 2009 pandemic vaccines, but they were based on influenza manufacturing vaccine design. But that was several months. Several, ok, but for months . Yeah. For example, how long has aids been around . Well, hiv, now about 20 years. Well, actually it goes back to around 1980, right . Right. So thats 40 years. Thats what i said. Ok. Have we got a vaccine that is efficacious, that prevents the transmission of aids . No. Hiv has been a really hard target because the bodies immune bodys immune response to the virus is clearly ineffective. So, the spanish influenza, maybe thats more of a parallel, that was 100 years ago, 19171918. Do have a vaccine today that prevents somebody from getting the flu . We have influenza vaccines. As you know, they change every year based on what strains are circulating. And we also developed vaccines against pandemic threats. You know, maybe an analogy to this is more like Something Like where in the course of a very like ebola, where in the course of the very accelerated development, a vaccine was available in a few years. But the point is most flu vaccines help with the severity of the flu. They dont necessarily prevent you from getting the flu. Fair enough . They do both, actually. They are more or less effective and that they typically reduce risk of an actual infection, depending on the population in the year. It could be 2060 but they are more effective like you said at reducing complications. Right. What im try to get at is were talking about efficacy as if it is a cure. But efficacy isnt always a cure. It is sometimes lessening the severity of the symptoms, or preventing the worst from happening, or at least showing up your immune system so you are better equipped to try to fight off infections. Fair enough . Yeah, absolutely. And as one of my colleagues just said, if we could reduce mortality or hospitalizations, that would be wonderful. I understand, but in this conversation, i think weve lost sight a little bit of what efficacy really means. It doesnt it isnt necessarily a cure. And the history of cures to a vaccine is very limited. Dr. Gellin, risk. Im old enough to remember what can go wrong when you rush a drug to market . That was a simple drug, antinausea, for pregnant women to make them accountable. And it led to terrible deformities in babies that were born. How do we weigh risk here when hundreds of thousands are dying . Millions are getting infected you want to try to end that. What risk is acceptable and what risk isnt and how to insulate ourselves, politically, from the pressure were seeing from this president and this administration to kind of cut corners scientifically already . What confidence do we have every taken into account risks . If 20 get accident and develop that seems to the high risk that would be unacceptable. If 1 of them nonetheless get covid19, that might be acceptable. Could you talk about that . Then i yield back. Your questions all point to the same thing. [inaudible] they point to the independent science of the fda to look at all the data and decision of deliberations. Its always a balance of benefits and risk. Nothing is perfectly safe and nothing is perfectly affected. And its that balance that we have to look at here. And thats mr. Chairman, i know i just a few seconds. Thank you, doctor. Could dr. Schwartz be allowed to answer it, as well . I saw him shaking his head vigorously and id like to hear from him and then i yield back. I agree entirely. Its a difficult question, i subthreshold, questions the how much evidence is needed and this is why we need to defer the kinds of structures and expert mechanisms to sort through these very challenging tradeoffs of any vaccine in the best of circumstances all the more so so this is why we have these systems. Its exactly these questions that youre imagining that might come down the line. Thank you so much, congressman connolly. Now, we recognize, i recognize katie porter, congresswoman katie porter for five minutes. Thank you so much. Dr. Gellin, im a mom with three kids and i want to make the best possible decisions i can for their health and for our community. And thats why every single year, we all get our flu shot. We wash our hands. We wear masks if were doing the right thing because i believe that science works. I believe that vaccines are safe and effective. Now, imagine were living in a world six months from now with the fda has approved a covid19 vaccine for use. But im a concerned citizen and ive been hearing a lot that the president pressured the fda to approve this do covid19 vaccine. Dr. Joachim, do you think i might be nervous about getting this vaccine from the kids if i thought the process was rushed or different than the other vaccines that i routinely and know that are safe for my kids . Dr. Gellin . For the same reasons, and that the information that comes from these studies is going up going to inform that. It also raises up the ship were to get your information and who are your trusted sources . I think another layer here is that while this data is very important and very expert committees will be good, its critical that people on the front lines, the doctors and nurses who are going to be delivering these vaccines, they are going to be asked questions by you and their patients and also feel confident in the process. They have to know that it was undertaken it away, the way that was going to bring about the best results and understand what that was, and they need to be the translators of that information. Theres probably no other trusted source than the people you entrust your health and her Childrens Health too. And if theyre not part of the solution, theyll be a part of the problem. And another piece of this is to make sure the data thats going to be reviewed is translated and provided to the front lines of medicine so they can answer questions like yours. No, i really appreciate that because i think most people are not going to be reading medical journals, not going to be going to the fda website. Theyre going to be googling. Theyre to be going to be on facebook and it will be asking their friends and youre right to point doctors and nurses are like my childrens pediatrician has been their pediatrician since then been born. But im also would i will not be getting the shot from the kids pediatrician or i will be getting it from a Mass Public Health setting, so i think its really important that the fda put out that information in an acceptable way, including to providers that we can reach out to. So, what happens if people hear these stories about the process being rushed . I actually am not i dont know. I havent got the usual information that i get. What happens if we are 4050 of the population gets the vaccine . Because they dont trust [inaudible] unfortunately, the story you mentioned is already out there, even before vaccines gets to the Clinical Trials. I think the solution or response is coming to and i can against this information to the degree that we cant which is not easy to do. That is separate from your question a lot of mathematical models about what it would take to achieve herd immunity to stop the virus. But i think that if we see the vaccine has worked and see that its damping the disease process, i think that will decrease the confidence of those who might be skeptical to ask a ask ask, well it is actually working and then they rethink a decision been made previously, which is why that information history is critical. We need to make sure the people on the front lines are able to respond to peoples questions like yours. Thats really helpful because i think weve seen in the past months what happens when the public doesnt understand or is given any kind of mixed signal about the Science BehindPublic Health and virus prevention has become more controversial. The science is there. Wearing something as simple as a cloth mask has become an aggressive debate. And social distancing become more and more controversial. The science is a bear. Things like Wearing Masks and vaccines do work but because we havent had a clear decisive message from the federal government about the scientific validity of things like social distancing and Wearing Masks, they become divisive. So we cannot risk the same thing happening with a vaccine because it so imperative that every person who can get this vaccine once it is developed does so. Is there anything more at the that the fda should be doing with regard to create that kind of Public Confidence for vaccine adoption . I think that we talked about the public process is an important part of it. Also, there needs to be an effort to communicate things in a way people can understand them. Often, the language of the experts is not so approachable so we need to be able to translate that so people can understand what it means. We had a discussion a few minutes ago what vaccine means. All of the panel can give you all the math behind it, but that doesnt mean the people who hear it understand it. Thanks so much and i yield back. Thank you, congresswoman. Now, i recognize john sarbanes, congressman survey congressman sarbanes. You have five minutes. Thanks very much, mr. Chairman. Can you hear me . Yes. I want to thank the panel. This has been a very, very enlightening hearing. I appreciate so much the testimony about how we have to balance speed with safety as we pursue these vaccines. I wonder, and i invite any respond too wants to this, if you could compare this Covid Vaccine pursuit with what Many Americans are familiar with, which is sort of the flu vaccine, and maybe compare it in terms of the way the Research Happens around the flu vaccine, the way that gets administered, the extent of uptake of the flu vaccine in the population, what is the confidence level around the flu vaccine, how do you compare that to what you were seeing in surveys about a potential coronavirus vaccine. And what are some of the practical dimensions of how we would be distributing a Covid Vaccine at the same time we would be distributing the seasonal flu vaccine . So, since thats the frame a lot of americans have in terms of a vaccine that comes at them on a regular basis, i wondered if you could droste and comparisons at could draw some comparisons analogies on those bases. I can address that. The flu vaccine, the big uncertainty has to do with blood strain of [inaudible] have to make best guesses about that but the knowledge to produce the antibody response once you identified which strain you think is going to be predominant is wellestablished. By contrast, in this case, we dont know how effective the antibody response is going to be from the vaccine. So, in that sense, more uncertainty about this vaccine then the flu vaccine, the seasonal flu effort. The same time the amount, the number of people in the trials is extraordinary that the we are going to have a lot of information about whether to some extent even more than so, i think its both more and less uncertain because we dont know about we know what the virus is, unlike the flu, but we dont know the strain. [inaudible] i think youve asked a critically important question. Because, as you said, in peoples minds, these are similar. Weve read a lot about the influenza pandemic. Weve heard about the parallels and we expect this is somewhat to be like influenza. And thats an important conversation because i think you just heard some of those. This figure that weve all seen about flattening the curve. That comes from work 15 years ago from influenza. You flatten out the curve to keep you out of the way of the Healthcare System until a vaccine arrives. Because its been decades of experience making influenza vaccines, we knew that we could do it. We knew we could get there. It was just matching the strength of the pandemic. This is different. We are flattening the curve to keep people out of the Healthcare System while were working on a vaccine that we dont know will work. Thats the key difference. You asked a number of questions we could distribution, the simultaneous use of vaccine and a Covid Vaccine. These are all very important questions and i think that we all need to be working on so there is an confusion about these two. So, thank you for asking. I have 45 seconds to get someone could just speak to this question of confidence in the public relative to the flu vaccine, what is the percentage uptake that we get on a seasonal basis of that vaccine . How does it relate to peoples perception of whether its risky or not risky or risk involved compared to what youre hearing out there to the Covid Vaccine . Just quickly, half the population gets the flu vaccine the confidence is not about safety. The confidence is about how well it performs. Theres a lot of work thats been done to try to improve the performance of the vaccine and thats people dont get is probably because of that now because any concerns you have about the safety profile. Thank you, mr. Chairman. I yield back. Thank you so much. I really appreciate everybody who participated in todays hearing, especially the panelists. Thank you for a grueling session of question and answers. And i also want to just conclude by saying that, you know, we all want a vaccine as soon as possible. And i think that goes without saying. And we also want to expedite the creation of a safe and effective vaccine. But the only way to do that come do that and i think theres relative unanimity on this particular point from everyone on this panel that we should not cut corners at the fda. Perhaps there might be some efforts to expedite what we do in the manufacturing of vaccines. Perhaps we think about the economics and the prioritization of delivery of the vaccine. Simultaneously, with the creation of such a vaccine, but we must not cut corners and do anything that would hurt or harm the conclusion that whatever the fda ended up approving is safe and effective. And so i hope that coming out at out of this hearing, we proceed based on those two conclusions to make sure that the fda does its job. Commissioner hahn answers our letter, that he assures us that he will continue to maintain the independence of the fda, that we will have 30,000 participants in any stage three human trial, and that it be engaged fully in the deliberations surrounding a covid19 vaccine. With that, id like to thank you all for participating in this session is adjourned. Give. [captions Copyright National cable satellite corp. 2020] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] be with us later today when pharmaceutical officials testify before the house energy and commerce subcommittee. You can watch it live starting at 10 00 eastern on cspan3, online at cspan. Org, or you can listen live on the free cspan radio app. Next, joe biden on clean energy and infrastructure development. His remarks were part of a series of speeches laying out his plan to safely reopen the u. S. Economy amid the ongoing coronavirus pandemic. He spoke from wilmington, delaware