still susceptible to this virus. >> just so i understand, you are saying that based from the preliminary indications from thor is the serological, americans have not had the virus yet. >> yes, sir. >> thank you. senator murray? >> dr. redfield, we know that a lot of patients avoid getting unnecessary tests or treatment because of cost and i've been pushing to make sure that insurers have to cover covid treatment at no cost to patient as we fight this deadly disease. meanwhile, president trump is fighting at the supreme court to overturn the affordable care act which would leave 23 million more people without health insurance and allow insurers to once again discriminate against people with pre-existing conditions leading to higher costs. covid-19 itself could become a pre-existing condition. so dr. redfield, let me ask you

straight out, would increasing the number of uninsured by tens of millions and increasing costs for the 133 million people with the pre-existing condition make it easier or harder to contain this pandemic? >> thank you, senator, for the question. clear clearly, access to timely health care is critically important in terms of public health, and in terms of this pandemic it's also true. access to timely, effective health care remains an important public health measure. >> i would take that as overturned that this would make it a lot harder to control this pandemic. dr. redfield, we have got to understand what happened with cdc's testing guidance for asymptomatic people exposed to covid-19. i am relieved that cdc reversed

course on friday, but i am concerned about why cdc put out guidance that contradicted the widespread views of the medical and public health community was not drafted by cdc scientists and did not undergo cdc's strict, scientific review process. dr. redfield, how is it a document published on cdc's website was not drafted by cdc scientists nor underwent the agency's strict, scientific review process? >> senator, the original testing guidance of august 26th had a full engagement of individual says at cdc, but it was a cooperative document that included the assistant secretary as well as the coronavirus task force, and i will say the intent of that document, as i mentioned before and i tried to clarify in my statement on august 27th was

never to limit testing and never to limit testing of asymptomatic individuals. the attempt was to re-engage the medical and public health community as part of testing so that there was a public health action that happened as a consequence of every test. it became progressively apparent that the guidelines were not interpreted in the manner in which we had intended them to be interpreted and that's what led me to realize that we had to put out a clarification to make it explicitly clear that we believe very much that asymptomatic transmission is an important part of the transmission cycle of this virus. those individuals when they've been exposed should, in fact, be tested. >> i appreciate that answer. i don't hear you answering the question, but let me ask dr. giroir. you said in an interview that coordinated editing of the guidance that you coordinated

editing of the guidance, the american medical association and the infectious studies of america and state health departments recommended testing for asymptomatic people. i want to ask you, on what scientific basis did members of the task force take a different position. scientific evidence. >> thank you, senator murray. i want to reiterate what dr. redfield said is that the original guidance that was published by the cdc with the -- >> i appreciate -- >> the approval of dr. redfield and the senior scientists did not, unequivocally, it did not recommend against testing asymptomatic individuals. in fact, it is important to test asymptomatic individuals, but in certain circumstances it's important to do that within the context of public health or medical supervision. that's all it said. it was widely misinterpreted. it was widely misrepresented and dr. redfield told the reason, we

have done fda guidance, clear guidance and i issued a declaration to assure -- >> please -- >> on friday cdc -- quietly updated another guidance identifying aerosols as common transmission of the virus that causes covid-19. yet on monday cdc reversed course. dr. redfield, you told me the earlier guidance had been posted in error, but especially given the trump administration's track record the reversal raises significant red flags. so here is my question to you, if i want the best guidance on the latest science so i can protect myself and my family, can i trust cdc's website to give me that information? >> yes. i'm going to say again that my agency and myself, we're committed to data and science and to give the american public the best public health recommendations we can based on that data and science, and be

open, if necessary, if the data and science changes to modify that guidance based on that new data, but we are committed to data and science and that will be the grounding of how we make these recommendations. >> mr. chairman, i am out of time, but i am concerned that the american public needs to be able to trust the decisions that are made and what's posted on that website needs to be trusted. >> thank you, senator murray. senator enzi. >> thank you, mr. chairman, for continuing to hold these regular hearings so that we and the american public can check onned federal efforts to fight the coronavirus. i know it can be hard for our witnesses to find the time to testify since they are all working very hard to respond to the pandemic, but i appreciate them being here and their information. i'm glad to see that we're making progress in planning how

we distribute a safe and effective vaccine when it's ready. i'm optimistic and pleased that there are all these efforts going forward. i hope we're thinking through how to ensure access, though, to rural areas. one of the things i'm asked about that people -- this is a question for dr. redfield and dr. hunt, some of the vaccines in phase three testing, evidently need to be stored in extremely cold temperatures. that's even by wyoming standards and that would be potentially as negative 3 degrees fahrenheit. hospitals, nursing homes, doctors offices, all of the places where americans can go to get their shots. however, they don't have the specialized freezers that would be necessary to store the vaccine especially in rural areas. so very few of those -- is there

another solution or how can we ensure sufficient freezer and storage capacity so there's access to the vaccine and it isn't just limited to major cities? >> thank you very much, senator. again, there's a total commitment to work that this vaccine has distributed in an equitable and fair way across our nation. the funding i announced today that will get out to the individual states to be able to really begin to operationalize their plans on the playbook is critical and each jurisdiction will have to address those issues, particularly as you looked at the importance of cold change and how they're going to maintain that. clearly, we have -- this is not something that we don't routinely do. i mentioned before, cdc routinely administers and distributes over 80 million vaccine doses a year through our

routine work. we're going to build on that. obviously, the ability to bring all of the pharmacies in is a really important step, but these microplans that your states say to wyoming will identify what other gaps are there and over the next four, six, eight weeks we'll need to figure out strategies that are going to fill those gaps to ensure that there's a proper cold storage for the vaccine distribution throughout this nation in an equitable way. we are committed to making sure that happens. >> dr. hahn, do you have any comment on that? >> fda's role, senator enzi, in this is to ensure that the controls around manufacturing and storage are followed. if, in fact, a vaccine is authorized or approved that requires such cold storage as you mentioneded, we will provide technical assistance and we'll work with cdc to ensure that that happens.

>> thank you. director redfield, do you anticipate that once the food and drug administration approves a vaccine, and you kind of touched on this the centers for disease control and prevention would have to work with the states to develop, new, more detailed vaccine distribution plans or will the work the states are doing in advance suffice? >> senator, it's very important, and i want to stress, this is why it's so important in the playbook we put out last week and the funding we announced today that we get these plans executed, we wanted to see the plans completed by october 16th so we can interact, share best practices of other states to try to get these plans as rock solid as possible. i'm confident there will be some things that were aren't thought of that will have to be dealt with as they come upon us, but

it's my expectation that each of the plans -- we've done the microplanning now in minnesota, in north dakota, california, for da and philadelphia over the summer just to get a sense on the complexity of it, and now we're looking for each of the 64 jurisdictions to complete that by october 16th and it is our hope that that's going to really lay out the individual plan to get this vaccine equity distributed in that jurisdiction recognizing that there will be things that come up that we'll have to work together to deal with as we see them, but hopefully those will be 95% of the way there buysed on the planning between now and october 16th. >> my thanks to you, chairman and the ranking member. >> thank you, senator enzi. senator casey? >> mr. chairman, thank you very much. i want to thank our witnesses for appearing and for their work. this week we've announced to the

world that we've reached the 200,000 grim milestone of deaths in america from covid-19. that number translates in pennsylvania into 8,000 deaths. so as we're thinking about those, all those we've lost, we now have to consider the possibility that covid-19 could be and likely will be considered a pre-existing condition just as the affordable care act would be struck down by the supreme court in early november, at least the arguments starting then. at the same time, we've got to consider the ravages of this disease, the covid-19 disease in the context of nursing homes. i released yesterday with senator widen, the headline of the report is the cost of inaction, 11 deaths an hour. 11 deaths an hour. that means in the months of july and august of this year, 11

nursing home residents died from covid-19 every hour in total when you look at the total number of the pandemic more than 78,000 residents and workers in long-term care facilities have died of covid-19 and unfortunately, the trump administration has no effective strategy, no effective plan in place to reduce this number. either to reduce the death number or the case number in long term care settings. this is an american tragedy. there's no excuse for these numbers to keep going up. we should not allow the next couple of months to transpire and have the number of nursing home deaths or the nursing home case number go up again. that is not the america we should be. now the majority in the senate could be doing something about this. the majority in the senate has been obsessed with confirmation

votes, all kinds of confirmation votes all summer long and we did the defense bill, as well, but mostly all of our votes run confirm eggs a confirmations and now the senate majority is obsessed with getting a confirmation vote on the supreme court justice. i just have one question for the majority, when will senate republicans and the trump administration become obsessed, yes, obsessed, with reducing nursing home deaths? let me get to our witnesses. i want to ask a question that dr. hahn was already kind enough to answer which was about the vaccine and his response to that in terms of his own family and his own -- his own person. one of the most important challenges we face in developing and then distributing and administering a safe and effective vaccine is public confidence. as a way to demonstrate faith

and the integrity of both the approval process and to assure the american public that vaccines are safe, i would ask the other three members of our panel if they would commit to receiving the covid-19 vaccine in public view when one becomes available and is authorized and approved by fda starting with dr. fauci. >> thank you for the question, senator casey. yes, i've said that in the past that if a vaccine has shown to be, proven to be and authorized by the fda to be safe and effective, i certainly would take that vaccine and i would recommend to my family that they take that vaccine. yes. >> thank you. >> i have every confidence in the fda process to provide us a safe and effective vaccine.

i would have no hesitancy to take that vaccine. i would have no hesitancy to recommend that to my family, but i think the question is a little bit inappropriate. people need to read that vaccine. they need to understand and have a discussion with their physicians or providers before you ask anyone to commit to that, but i just want to tell you, i have complete confidence in the fda process. >> dr. redfield? >> senator casey, yes. absolutely as i would with my wife, children and 11 grandchildren, i would recommend it to all of them and of course, myself, i would take it. i have total confidence in the fda and in the process of getting us a safe -- i am confidence it would be a safe vaccine and i'm ready to take it. >> dr. redfield, i have a question for you on state immunization information systems in light of the vaccine program interim playbook. i have one question before my time expires.

how many jurisdictions immunization restrictions meet all of the standards in the playbook today? >> senator, vii would have to g back to you to answer that specifically. i will say that we are building on the system that we regularly use in these 64 jurisdictions to distribute 80 million vaccine doses a year. in addition, there will be additional information capacity that will be put in to where there are new points of service where that technology currently doesn't exist, but i will have my team put together a comprehensive answer for that for you. >> thank you. thank you mr. chairman. >> thank you, senator casey. senator burr. >> thank you very much. welcome to all of our witnesses and our thanks to your agency and the many workers who work on this and let me say to senator casey answering his question. the majority has been focused on

the pandemic when we started passing legislation the architecture that we fall under today and the protocols that allow dr. hahn, dr. fauci and admiral giroir to do what they're doing and we thank you for that. dr. hahn, have we made up new protocols for the review of a covid vaccine or are we simply following the protocols that we've used for every vaccine that every member of this committee, every committee of congress and the american people have always seen as a gold standard? >> well, with respect to our approval or authorization of medical products, fda does represent the gold standard. the statutory definition for an eua or authorization is different than it is for an approval, but we're following those criteria with respect to our performance during covid-19. i want to give you a few examples because in fact, you're correct. fda does represent the gold

standard. our scientists are incredible. they've done really remarkable work here and one of the major things that distinguishes us from other regulatory agencies around the world is that we actually look at the primary data. we don't just look at a paper. we don't just look at a press release and we look at the primary data and our scientists analyze that data and then we draw conclusions from that data. we did that with remdesivir and we did that with convalescent plasma and we're doing with tests and so those are the sort of things that fda does that i believe represent the gold standard and allow us to have great confidence in the decisions that our career scientists are making. >> dr. hahn, would it be appropriate to say that the clinical trials, phase three clinical trials that are currently going on now for manufacturing, i think the fourth one announced this morning are the most expansive and diverse trials that we've seen in recent memory just

simply because they are global trials and typically we haven't picked up that international data until post-approval in many cases and reviewed it? >> senator, it's correct to say they're mook the most diverse and expansive trials and that's a reasonable way to put this. we were very clear in the june 30 guidance with what we needed to see with respect to efficacy, a floor, not a ceiling of 50% which led to the calculations of these trials and therefore 30,000 plus volunteers in each of these trials and if you think about the number of trials that are ongoing and plus the studies that were done before in phase one and phase two are great, if you will, a number of people who would have received these vaccines which will give us the data that we need to see in order to make the determination. so these have been very robust. the private sector has responded and the government has responded and i think it's been a great effort to get these trials

together. >> dr. hahn, you talked about the steps that an applicant would go through and how it would be their decision to how it would apply for emergency use authorization or approval and one thing you didn't mention and you left out is the data safety monitoring board and the dsmb which actually looks at the data prior to the application coming to the fda, is that, in fact, correct and is that another safety step? >> senator burr, it's another check and balance in addition to the other. let me just explain that, if you will, sir. when a sponsor, someone that's developing a vaccine, a company performs a phase three clinical trial, there is something called a data safety monitoring board and that is an independent board and they have set check-ins to look at the data. when they meet they can mack a couple of determinations, one, if there's significant safety issues they can stop the trial because of safety issues. number two, they could do what's called a futility analysis,

meaning that continuing that trial won't do any good because there's not a statistical probability that it would reach the primary end point that could be successful and they could have met the pre-specified criteria around effectiveness in the case of the vaccines and prevention of infection and that would be another criteria that would be used to say, okay, the data are mature, give it to the company and then the company can put that into an application to us. >> thank you. dr. fauci, i want to turn to you just real quick because the moderna vaccine works off of a technology platform that you actually created at nyad. are you confident of the process that's going on at the fda that will, in fact review the application of clinical data from that platform and as an add-on to that, would you also answer for members of congress for the husband and wife that

come to us and say my husband got covid and the wife didn't get it, how would a highly transmittable infection like this can two people live together and one be positive and one never get positive? if there is an answer -- >> yeah. that happens all of the time with infections, senator, that although a virus can be highly transmissible, there is a great degree of variability of a person's natural resistance to a particular type of an infection. so although a highly transmissible virus usually has an attack rate that's high, we see all the time individuals who are exposed to someone with an infection who do not get the infection. if you look at the population as a whole, you see the kinds of things that you're seeing as this pandemic evolves that it is

highly contagious. we had the same situation where you had hip where individuals were living with a person that had sex on a regular basis with someone with hiv and they never got infected. whereas another person could have sex one time with a person with hiv and they get it. that's the susceptibility of infection among individuals and it's entirely conceivable. >> your confidence -- >> we are running well over time. >> absolutely. the answer is yes, i'm quite confidence in the fda based on the data of the trial. >> thank you, mr. chairman. >> senator baldwin? >> thank you, mr. chairman. dr. redfield, in april the cdc staff conducted an investigation into a covid-19 outbreak at a meat packing plant in south

dakota. following the investigation, your staff sent a report to the state that is south dakota's department of health that included strong safety recommendations the cdc determined were necessary to stem the transmission of covid-19 at the plant. that -- that report was dated april 21st of this year. last night it was reported that your office intervened and ordered that the safety recommendations be watered down. the next version of that memo dated the following day or april 22nd essentially adds to the words if feasible to the strong safety protocols over and over again throughout the document,

telling the plant essentially that these recommendations were voluntary or optional. workers continued to work shoulder to shoulder at that plant and the plant ignored the safety guidelines. to date, at least 1200 workers from that very plant have been infected with covid-19 virus, 34 have been hospitalized and four have died. and we'll also note that in that same time period in april, on tuesday, april 24th or 28th, excuse me, that's when president trump issued his executive order basically naming meat packing as an essential industry in meat parking workers as essential workers. i'd like to enter the two documents i referred to the april 21st and april 22nd safety

recommendations concerning this meat packing plant, if that's okay, mr. chair, i'd like unanimous consent to do so? >> i think i heard someone indicate that i got unanimous consent. dr. redfield, why did your office demand that he's recommendations be watered down? >> thank you very much, senator. i wouldn't characterize it the way that you did. what i would say is that the field teams that we had that were in on the smithfield plant investigation that you're referring to had a report that they did in the field and they shared it with the local south dakota health department. one of the critical things that needed to be stressed in that report was that cdc is not a regulatory authority. these were, in fact,

recommendations. the department of labor and osha have regulatory oversight and their report can direct that regulatory oversight. our report was recommendations from an epiaid and as that document was reviewed we wanted to make clarification that made sure people understood ours was a recommendation and not a regulatory requirement. >> thank you, and i will note that osha and the department of labor have failed to issue anything but voluntary guidance as has cdc. there are no pandemic emergency standards in place for workplaces in the u.s. even though they've had eight months to work on this, but that's not your responsibility. did your office have any contact with smithfield foods or the u.s. department of agriculture or the white house concerning

specifically this memo before it was edited? >> no. not at that time. there is a multiinteragency discussions between labor,ing a culture and ourselves on a variety of the issues that intersect, but in that regard, again, it was -- the purpose was to stress clarity that we were not a regulatory agency and these were recommendations. >> well, given that i would ask you to consider changing the meat being paipacking guidance, say we are not a regulatory agency and these are the safety protocols that we would recommend and not have, if feesible, if feasible, if feasible, it makes it sound like these are not particularly important if you can do it, great. if you can't -- you can say these are our safety recommendations without it being

construed as an osha standard, and i would ask, will you change that meat packing guidance in light of the death toll and harm? >> i appreciate your comment, senator. >> thank you, senator baldwin. senator paul? >> initially, government officials were honest enough to admit that the goal of mitigation efforts, aka, lockdown was to flatten the curve, but the area under the curve, the total deaths from the virus would likely be the same. in other words, the lockdown was to mitigate the spike in viral deaths or our hospitals would not be overwhelmed, but the same amount of people would likely die with or without the lockdown, the media and frankly government officials seem to have forgotten this important caveat. flattening the curve morphed into a belief that we could change the course of the pandemic with an economic lockdown. this is unfortunate and has led

to the protracted lockdown recession we're currently mired. it's important that we examine the data, learn from the data and try to avoid the man made aspect of this calamity in the future. to those who argue that the lockdown flattened the curve in new york and new jersey, the evidence argues otherwise. new york and new jersey wound up with the sharpest spike or highest death rate in the world at over 1700 deaths per million, in contrast, sweden had a relatively softer touch. few mandates and mostly voluntary guidelines and sweden's death rate ended up about a third that of new york and new jersey. some might argue that sweden and new york and new jersey are different population, perhaps, but even the average death rate for the u.s. is now greater than sweden. in fact, the u.s. death rate is quite comparable to less developed parts of the world where social distancing is virtually impossible such as brazil, bolivia and ecuador

which brings us to an important question. is man really capable of the disease with crowd control. the statisteics argue a resounding now. most countries regardless of public health policy suffered a significant spike in deaths and then a gradual decline. some will argue what about hong kong, taiwan, south korea, japan? each which have had extraordinarily low death rates. hong kong, taiwan and south korea certainly enforced stricter quarantine and contact tracing than the u.s., and japan's rules were largely voluntary since their prime minister lack the legal powers to enforce a lockdown. one explanation for the death rate in much of asia is that the population may have a higher degree of exposure to coronavirus colds, coronavirus colds and therefore have more pre-existing cross-reactive immunity. if scientists were interested, there is a fascinating field of

inquiry looking at susceptibility to covid-19, an assessment of people would have pre-existing immunity to similar coronaviruses. in fact, pre-existing, cross-reactive immunity to coronavirus may explain why we have so many people that have very little symptoms or asymptomatic. there are things we need to learn about this pandemic and it is important that we, the people, not simply acquiesce without first making the nanny state prove their hypothesis. as for now, what we do know is that new york and new jersey and connecticut and rhode island still allow the highest death rates in the world, and we also know that sweden who enforced few mandates ended up with a death rate one-third of new york and new jersey. we also know that the overall death rate for the u.s. now is essentially equivalent to that of south america where social distancing and mitigation efforts are virtually

impossible. dr. fauci, today you said you are not for economic lockdown, yet your mitigation recommendations from dating to baseball to restaurants to movie theaters have led to this economic lockdown. do you have any second thoughts about your mitigation recommendations considering the evidence that despite all of the things we've done in the u.s. our death rate is essentially worse than sweden, equivalent to the less-developed world that is unable to do any of the things that you've been promoting? do you have any second thoughts? are you willing to look at the data that countries that did very little actually have a lower death rate than the united states? >> senator, i'd be happy at a different time to sit down and go over detail. you've said a lot of different things. you've compared us to sweden and there are a lot of differences and you said, well, you know there are a lot of differences between sweden, but compare sweden's death rate to other

comparable scandinavian countries. it's worse so i don't think it's appropriate to compare sweden with us. yes, we have, i think in the beginning we've done things based on the knowledge we had at the time and hopefully and i am, and my colleagues are humble enough and modest enough to realize that as new data comes you make different recommendation, but i don't regret saying that the only way we could have really stopped the explosion of infection was by e having the physical separation and the kinds of recommendations that we've made. >> you've been a big fan of cuomo and the shutdown in new york. you've lauded new york for their policy. new york has had the highest -- on how can be be jumping up and down saying cuomo did a great job. >> you've misconstrued that, senator, and you've done that

repetitively in the past. they got hit very badly and they made some mistakes. right now, if you look at what's going on right now, the things that are going on in new york to get their test positivity 1% or less is because they are looking at the guidelines that we have put together from the task force of the four or five things of masks, social distancing, outdoors more than indoors, avoiding crowds and washing hands -- >> or they've developed enough community e muni community immunity because they have enough to actually stop. >> i challenge that, senator. please, sir, i would like to be able to do this because this happens with senator randall a the time. you are not listening to what the director of the cdc said that in new york it's about 22%. if you believe 22% is herd immunity i believe you're alone in that. >> there's also the pre-existing immunity of those who have

cross-reactivity which is about a third of the public which would actually get you -- >> i'd like to talk to you about that also because there was a study that recently came out that pre-existing immunity to coronaviruses that a common cold do not cross-react with the covid-19. >> thank you, senator paul. senator murphy? >> thank you very much, mr. chairman. i'll stay with you, dr. fauci, i apologize for not giving you a break. there was a study that got some attention regarding big ten and pac ten athletes that found that 15% of them who had covid-19 whether or not they showed symptoms had evidence of miocarditis, an inflammation and damage to the heart muscle. what are the long-term effects for someone with miocarditis. what are the long-term effects of someone who has had covid and recovered and are these effects

recoverable in covid-19 patients? >> senator, thank you for that question. i actually had mentioned that in my opening comments and thank you for giving me the opportunity to expand on that. that's really quite puzzling because the individuals that -- there were two studies. there was one study not in athletes and there was a study that you mentioned in athletes. the study in the non-athletes were individuals who had recovered from covid-19 and had various degrees of involvement, moderate disease to disease that would require intervention medically and by doing mris they found that about 60% to 70% of them had indication of inflammatory disease in the heart. interestingly, they were relatively asymptomatic, so i think we need to be careful and just watch what happens because one of the possibilities that could develop is that a, it could clear up and they have no problem for the rest of their lives. the other things that they could wind up when you have inflammation, you could have

scarring. that could lead to a ritrrhyth later on or cardiomyopathy, it's something that we have to keep our eye on. >> they have to err on the side of caution and what we believe is because of this uncertainty and the potential for long-term health effects that any diagnosis of covid whether you're symptomatic or not will become a pre-existing condition and that it is likely probable that insurance companies, if they are allowed to discriminate against people with pre-existing conditions as will happen if the supreme court justices put on the court and the ac has invalidated, we will see rates skyrocket for anybody who has had covid, i think something we all need to talk about over the course of the next few weeks. dr. redfield, admiral, i want to come back to this question of the guidance on testing. i think this is really important

because, you know, we have to take the president at his word. he announced that he had instructed his advisors that, quote, slow the testing down, please when folks suggested he was kidding he was asked by reporters are you kidding and he said i don't kid. let me just tell you, let me make it clear. so the president made it clear he wants less testing and so it didn't seem coincidental to us that this strange guidance came out in august that recommended significantly less testing, and yet that's not what you're testifying to today. you're both saying that in fact, that august guidance didn't recommend less temptisting and you were doing with this third set of guidance in 30 days was to clarify, but where in the august guidance does it tell people that they this get a test if they are asymptomatic, but in

close contact, where in the guidance does it tell them that they should proactively see a health care provider if they have been in contact? because i've read it 20 times and i don't see anywhere in this guidance that it tells people they should get a test. i don't see anywhere in this guidance where it tells them that they should go see a doctor. it reads, you do not necessarily need a test unless you are a vulnerable individual or your health care provider or your local health o fishes recommend you take one. that doesn't say you should go to the doctor. that says if you have been recommended to get a test you should. it stands to reason that when folks read this they will be under the impression that they shouldn't get a test which seems to, fo comport with the preside where in this guidance that you issued in august tell people that they should get a test or should proactively see a doctor?

>> thank you very much, senator, and as i've said before, i take the position that more tests will actually lead to less cases particularly if it fully engages public health action, and when i issued the clarification on august 27th, again, i said that we are placing emphasis on symptomatic illness and also as you said, individuals with significant exposure and vulnerable populations and critical infrastructure workers and health care workers and those individuals who may be asymptomatic when prioritized by a medical or public health official. the reason that this came from the public health perspective, we were seen with individuals drive up and get a test and go on to work. was it a public health action associated with testing, so we calculated that this would help bring a public health action to testing. >> notably, you don't tell people in this guidance that they should go see a doctor.

>> when i said, when we clarified the day after i put very clearly what the clarification was about the emphasis and the final category with those individuals who were asymptomatic when prioritized by american or public health individual and again, the intent was for testing to drive inaction that was for a public health objective. it was clear through a variety of different reasons when we found that some individuals were not even doing testing for contacts, the individuals with significant exposure and we then put to further clarification. i had thought that the august 27th clarification statement that i put out would carry the football over the goal line and it doesn't, but i can tell you there was no intent to this guidance to decrease testing. on the contrary, the intent was to link testing and to drive a

public health action and -- and again, the manner in which it was interpreted by a number of individuals that they didn't accomplish this goal. >> i'm over my time and this has been dizzying for public health professionals. they're just awaiting the next correction. >> thanks, senator murphy. in my effort to be fair with everybody, we are running over the five minutes pretty well. we have about 14 senators remaining who would like to ask questions so i would ask colleagues to keep that in mind, please, with the five-minute rule. senator collins? >> let me begin my questions today by thanking each of you for your hard work, your professionalism and your integrity. i don't think you get the appreciation that each of you deserves. admiral, the american people clearly need to have confidence

that all our federal health agencies will abide by their gold standard, rigorous protocols and preserve scientific integrity and we have heard this morning just such strong assurances. nevertheless, just last week secretary azar barred the nation's health agencies from signing new rules themselves regarding medicines or medical devices as they normally would do. such a major change at this critical time could delay progress and cause the american people to doubt whether the proper protocols are being followed. could you explain why these

changes are taking place and whether they could affect new medical countermeasures for covid-19? >> so thank you for that, senator. i've spoken to several people in the immediate offices of the secretary and as i understand it, and i do absolutely believe it, that this was an administrative decision by the secretary because rule making authority in an agency that has 90,000 people gets disseminated broadly and widely and he wanted to make sure that whatever rules were proposed by fda or other rule-making organizations had review and scientific integrity. i do not believe that this will interrupt the process. you have my commitment to make sure that i will provide the best public health advice to the secretary on all these matters. i don't believe it will make a difference, and these can be redistributed back out. this was an administrative process, as i understand it to bring them back in, to gain

control so that there aren't hundreds of different ways to make rules during this very important time and perhaps dr. hahn, as a rule making agency might have a comment on that, as well. >> i have a different question for dr. hahn, but i want to make sure i get to, let me say that while i appreciate your assurances, if everything is going to have to flow up to the secretary it seems inevitable that it is going to create delays and doubts, and neither of those are helpful as we deal with this pandemic. dr. hahn, i want to bring up with you an issue that we discussed many times ask that is the fact that so many of our active pharmaceutical ingredients for medicines for the american market are manufactured overseas. in fact, 72% of the facilities

are located overseas in countries like china and india. india put an export ban on some 26 apis. we know that china hoarded ppe that our country needed. so my question to you is are we making any progress in ensuring that the apis that may be critical in therapeutics for treating people with the coronavirus or the ultimate vaccine are manufactured right here in the united states and not in china or india or somewhere else? >> thank you, senator collins. you bring up an incredibly important topic and one that i think has been very much highlighted during the pandemic. we have seen situations where the lack of redundancy in our supply chain, the lack of

domestic manufacturing has led to shortages here at home. so we have been very active and believe we're making progress with respect to what we're calling advanced manufacturing. senator collins, we have spoken about this many times, and the issue of making sure that we have this redundancy through advanced manufacturing is important and something that has been involved with manufacturing for years. with respect to the medications and ppe, i know that the white house task force has been particularly focused through fema, and now hhs on making sure that we build up our domestic capacity particularly around ppe and so yes, those are in progress. it remains a top priority for the food and drug administration and our role in this would be to help to create whatever regulatory pathway we can so that we can facilitate advanced manufacturing that's domestic. >> thank you very much.

>> . thank you senator collins. senator warren. >> thanks mr. chairman. seems our best chance to end this pandemic but americans won't take the vaccine if they don't trust the federal officials promoting it. if federal officials stand to gain financially from certain covid vaccines and not from others, then americans might reasonably worry that the vaccine was pushed for personal profit and not because it was best for our health. so i have a question for all of our witnesses, and i think you can answer with just a simple yes or no. dr. fauci, do you hold direct financial investments like stocks in any of the companies that are developing covid-19 vaccines? >> no. >> thank you. what about you, dr. redfield? >> no, senator.

>> all right. dr. kahn? >> no senator warren. >> and admiral giroir? >> no senator. >> thank you. none of you stands it get richer if any particular drug company gets money from the government. i'm not surprised by federal law prevents you from owning stocks like that. public health, not money, guides your work for the american people and that's exactly how it should be. dr. ed fda is responsibility for depending if a vaccine is safe. if the fda had financial conflicts, your opinion, would that increase or decrease people's confidence in a covid-19 vaccine? >> senator, i'm not aware of anyone at fda that has a conflict related to vaccines involved in that decision-making process. it would be difficult for me to speculate on that since we have very rigorous standards in

place. we have monthly review, particularly of senior officials. we have regular training, and we have a culture at fda which looks at the issue of self-declared as well as office of government ethics review of all conflicts. senator, i'd like to say if anyone is aware at fda with a conflict represented to these i would personally want to know because we will address that right away. >> i very much appreciate this. you're saying that financial conflicts are a real problem in the drug and vaccine development process. but here's the problem we've got. dr. manseth slowey, the man that president trump selected as the government's "vaccine czar" is is a former drug xaktiv-- hiredo

keep conflicts from the public. reportedly onlies about $10 million of stocks in glaxosmithkline, a drug company working on a coronavirus vax ooend andvax -- vaccine and may only stocks in lanza group, a company working with moderna. another pharmaceutical company trying to make this vaccine. why does this matter? we "operation warp speed" the federal vaccine project that dr. slowey heads up has invested billions, that's billions, of dollars in the companies that dr. slowey holds stock in. so, dr. hahn, you and other fda officials involved in the covid-19 vaccine must comply with conflict of interest laws. you've just told me how seriously you take that. so can you explain to me why dr. slowey should get to play by a different set of rules? >> senator warren, i can't

explain the situation. i don't have any knowledge of what you describe. what i can tell you is that we have established a very bright line between "operation warp speed" and fda. we do not participate in their decisions. we provide technical assistance just as we would for any sponsor. >> so with all due respect, dr. hahn, you just told me financial conflicts of interest basically undermine the public's trust in a vaccine and dr. slowey has conflicts of interest. so to boost the public's confidence, shouldn't he eliminate these conflicts? >> senator warren, i am not aware of the conflicts you are describing. so i can't comment -- >> hypothetically, if these conflicts exist and we'll only know were you a full ex-closure. there's evidence.

if these conflicts exist, should he resign? >> in a hypothetical situation that you're describing, again, i can't prejudge because i don't know the facts but i do take very seriously the issue of conflicts of interest and how that might affect public perception. >> let me put it this way. congress should strengthen the federal ethics laws to root out this kind of corruption. it should pass the rb coronavirus oversight and recovery ethics act, which is a bill i introduced, in order to prohibit conflicts of interest in the federal covid-19 response. and the first person to be fired should be dr. slowey. the american people deserve to know that covid-19 vaccine decisions are based on science and not on personal greed, and congress should pass my bill today. thank you, mr. chairman. >> thank you, senator warren. senator cassidy? >> thank you, mr. chairman.

i was distracted when the senator was giving his answer but may have replied to senator casey. senator casey didn't here admiral giroir's testimony. nursing homes, heard how many are deployed to nursing home, in case he wasn't able to raise that i want to emphasize that. commenting on previous testimony secondly, dr. redfield, i thought you answered senator baldwin's question very well but i will say my office called osha as regards guidelines for people who are, you know, from businesses in terms of how to contact themselves, and osha has said they are deferring to cdc. that's not cdc's fault, mr. chairman. i recommend we have a hearing with osha to straighten that out. that's a good point. dr. giroir, the -- the -- it's my understanding that the

administration's granting authority to pharmacists to immunize those between ages 3 and 18, because of the crisis we've had a kind of slowdown, and those children, they're missing their vaccines that they should get. is there going to about requirement that they put these vaccine records in the states immunization registry? >> yes, sir. >> what about federal facilities sump as d.o.d., v.a., indian health service, et cetera. likewise entering their data into the states registry? >> i actually don't know about d.o.d. i don't know that specific. i know that for the pharmacists, of course, and anyone in the civilian population, they are required. that was a part of the prep act declaration, and my guidance about that. >> and just a suggestion that d.o.d. should be required. obviously many will be separating from the military and it may be a condition of employment by a health care facility that someone be

vaccinated. nice have that documented as a opposed to someone stating they have been. just to point that out. >> yes, sir. i wasn't commenting whether good or bad. i didn't know the regulation for dmplg d.o.d. we'd be happy to look it up and brick it back. >> not fussing. kind of pointing it out. now, dr. redfield -- maybe dr. giroir. i understand the vaccine can be given without cost to the patient, but there is a concern by the provider that they would be compensated for all of their costs associated with administering the vaccine. so in the guidance coming out that the american will not have to pay, but is there still going to be compensation for the provider who is administering the immunization? >> so, thank you, senator, and lem speak generally that, of course, we would assume there are costs for the provider. these are going to be tens or

hundreds of millions of vaccines. there are details to be worked out the administration committed to assuring that no patient has out of pocket expenses whether for the vaccine itself or for the administration of that vaccine. >> got you. dr. hahn, the -- vaccine -- may only have 50% efficacy. that's the fda's minimum, as to considering whether a vaccine is effective. is that efficacy 50% of the time. presumably the level of antibody response would be a marker as to whether or not somebody has had a response. so my question is, for those folks who are at higher risk, take the emergency room nurse. the tech or the clerk admitting people to the e.r., will antibodies serologies be required after the vaccine is given, and do we have enough antibody serologies, serologic

tests have are sufficiently accurate and available in order to contact this? >> senator, thanks for the question. for the first several trials, when they mature, we will not yet have data that bridges between a clinical outcome, which is the, of course, primary end point we've required for showing its effectiveness. that is, the previous of covid-19 illness and the development of antibodies. so it is unlikely in that situation, although again, i can't prejudge the data we'd have a requirement. again, the data will point in that direction. for subsequent trials if in fact there is bridging damt ta or from the original trials one can imagine a situation that would occur. but again, don't know that because we haven't seen the data yet, sir. >> thank you for your brief answers. i yield back. >> thank you, senator