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i have interfaced with a lot of you before but my name is abe aurig i am the communications director with one day sooner um and yeah very happy to um have this opportunity for journalists to get a chance to ask questions to signatories of one day sooner's open letter um so yeah as many of you know of course the signatories know one day sooner is an organization that started around three months ago to recruit interested and willing volunteers for a potential covet 19 human challenge trial and currently there are over 32 000 people from over 140 countries who have indicated that they would be interested in taking part in a challenge trial around two weeks ago one day sooner released an open letter to dr francis collins that i'm linking in the zoom chat now and of course we're joined by many signatories of that open letter and as momentum builds for coven 19 challenge trials there's widespread agreement by stakeholders that public engagement is very crucial and it's important that the public uh knows the logistical and ethical considerations that surround challenge trials and so yeah myself and other people at one day sooner including isaac martinez who is the project manager on our open letter are very grateful that there are journalists who are covering this issue and we're also very grateful that many of uh the distinguished signatories on our open letter have taken the time out of their very busy schedules to answer some questions from journalists about their decision to write the open letter um and so yeah we think it is you know important for the public to know you know what challenge trials are how they differ from traditional phase three trials uh what the benefits are what the risks are and why people from many different academic disciplines have decided to uh call on the nih to begin preparation for these trials um so with that said uh just a little bit about the call itself this call will be recorded and all comments will be on the record unless uh you wish to indicate otherwise immediately before or after your comment um and it will mostly be an open floor uh from journalists uh to have an opportunity to ask signatories questions um about the the open letter and about human challenge trials um and so with that said i think we can go around and just do some very brief introductions uh if you could just say your name uh and your your affiliation um so uh yeah i'll begin again just for people who have joined the call my name is av i'm communications director with one day sooner um isaac do you want to go next yeah um i'm isaac i'm the project manager from one day sooner so uh for all our signatories i'm the one who got the emails from yeah amelia hi um i'm emilia i'm a documentary filmmaker for uh bbc and cnn feature films as well thank you uh john authors hi uh i'm a columnist for bloomberg and also gets indicated in the washington post uh jane whitfield uh jane are you there maybe on mute or on background um beth wang um sorry i'm not gonna be on video but um beth with inside health policy in washington dc reporter thanks uh laura hi uh i'm with public news service and i also freelance for other outlets like 100 uh charlotte gardner where are you i'm with nbc in london thank you um uh professor kalin uh bill kale and i'm a physician scientist at harvard uh medical school and a 2019 nobel laureate in medicine professor reckler hi i'm professor of ethics and population health at the harvard school of public health professor holloway i am carla holloway emeritus law and literature at duke university uh professor roth uh i'm al roth i'm an economist at stanford university and sir richard roberts uh i believe you're on mute i'm rich roberts i'm chief scientific officer at new england bio labs and the 1993 nobel laureate in medicine and uh professor kaplan hi eric kaplan i run the medical ethics division at nyu school of medicine uh professor rafael yes hello everyone i'm nadir rafaela mercedes professor of medicine at emory thank you uh and just in time is josh morrison uh josh we're just doing uh introductions and our affiliation hey this is josh morris and i'm the executive director of one day center great thank you so much so uh now we can have an open floor where journalists can ask questions to signatories uh you can feel free to ask openly to the panel or you can direct your question to a specific specific signatory you can also ask directly or if you wish to put your question in the zoom chat and then i can announce the question on reserve we also have some questions some frequently asked questions from volunteers so time permitting we'd love to ask those as well but for now uh we can open the floor actually first let's just get some introductions from two people who joined the call um i believe they're joining audio right now um hi kara we're we were just doing introductions and uh naming our affiliation are you there okay i guess on background for now um okay so we can open the floor um so for for any journalists who have any questions about uh human challenge trials for any of our signatories hello um could i start there's obviously lots of fascinating scientific and moral questions to come but could i just start with a a practical question so i understand what precisely you're trying to do who do you need to appeal to are you just appealing to the american authorities or are you uh finding volunteers are there other authorities regulatory bodies in other countries that you need to convince and how many of the different candidate vaccines are interested in using human challenge trials are you sure that there are people who will you know if volunteers do very bravely and we're all very grateful to them come forward are we sure that there are scientists who will use their services uh this stanley plotkin um uh in point of fact the uh people in the uk are also interested because the oxford vaccine as you probably know is in an an advanced state of development and there may be others in uh in in europe now uh obviously as we all know uh britain is splitting from the eu so it's not clear what uh uh what the um the result will be as far as as uh management of of um regulatory issues are concerned but we one can say for sure that the uk is interested and do you mean by that that the oxford you know this is obviously other very exciting vaccine program that's candidate vaccine from oxford would be prepared to use human challenge trials if they can persuade the relevant british authorities to to let them do them that's my understanding yes this is josh um yeah that's what's been publicly reported by the guardian is the oxford vaccine team's interest at the oxford jenner institute and you know we have talked to a few other different groups that would be interested in in using challenge studies to test their vaccines uh vaccine candidates um but unfortunately the the details of those are confidential at the moment um but i think you know oxford as the first covenant vaccine candidate uh to get into phase three testing um is you know one kind of good example of this and in terms of the kind of regulatory barriers or sort of who has to say yes um it varies a bit by by geography so the regulatory standard in the u.s is going to be different than it's going to be in the uk and in the eu i think that you know basically the the biggest hurdle is going to be just getting the the irb approvals the institutional review board at the um the different institutions that could run one of these studies uh in the u.s you would also likely need the fda approval as well um but that is not necessarily the case uh in in cities down outside the us um and the other thing in the u.s you know we're uh you know i think um as an american myself uh and very proud of the history of the national institutes of health and the nih has a lot of expertise in challenge studies and have publicly announced they're preparing challenge virus but you know it's a very open question of whether they're going to be willing to run an infectious dosing study or other challenge studies and you know with all respect to the really brilliant people at oxford you know of all the people in the world i would love to have the nih be one of the groups running these challenge studies and so that's one group that we would hope to to advocate to persuade to use these nice go ahead yeah um from my understanding these trials are are quite they're very small it's like 20 people and obviously i think most of the or the candidates have to be in their 20s for me that seems i'm just wondering how efficient that is right because people are in their 20s are much more likely to recover from covet and how the results coming from these trials are going to be so small scale and obviously looking at very healthy candidates and if you guys can comment a bit on that well um if you wish i i i will comment this dr platkin again uh so the point of having healthy people is to reduce the risk of serious disease but without going into a lot of detail which is already in the literature what challenge trials hope to do is to identify certain or rather to answer certain important questions for example what are the or what is or are the immune responses that are protective against disease uh that is spread of the virus from the nasopharynx to other parts or or for that matter what will protect the nasopharynx from being infected and it will allow the analysis of immune responses in a way that is not easy to do in regular phase three trials because their uh people are becoming ill um and one gets there after the fact whereas uh in challenge trials you have specimens before the challenge yeah and and this is bill calen if i could follow up so because this is an important question so first of all i think most would agree that a candidate vaccine that didn't work even in the most ideal circumstance the young and healthy might be quickly excluded but there's value to that also given the number of vaccine candidates conversely if it turned out that the vaccine only worked in the in the relatively healthy yes it would have to subsequently be validated in a sicker population those at greater risk but nonetheless even a vaccine that only worked amongst the healthy could be a first step towards achieving herd immunity and we've all seen these pictures of young healthy people congregating because they feel like they're immortal so maybe this would be a first step towards achieving some degree of herd immunity realizing that you would need subsequent validation that the vaccine also worked in a sicker population really helpful thank you so i just received a question from beth wang and i'll read aloud now um fda's biologic center director peter marks has said that the agency wouldn't rule out challenge study designs for covet-19 vaccines but the agency would have to carefully consider and weigh the ramifications of any protocol before moving forward with it have you all spoken with any companies or researchers that would have to go through the fda for this or even the fda or even the fda itself to get an idea of how they're resolving some of the questions about challenge trial designs and what challenges or hurdles do you see on the us regulatory side well if no one else is offering i'll take a stab at that everyone who works in biology in the u.s is well aware of the exigence exigences of the fda and the necessity when doing clinical trials to satisfy uh the fda now i've talked to people at the fda and of course many others have as well and i think it's fair to say that they are not against human challenges what they want and what they should want is protocols that will answer important scientific questions uh in a way that is as safe as possible for for the volunteers and so that they will want to know how was the challenge virus constructed and a lot of details about that what tests were done and what circumstances of challenge will be how the uh volunteers will be protected housed etc and all that is perfectly reasonable what i would say and i believe i'm right is that the fda is not against the idea but it will have to be satisfied that these challenges will be done in the safest uh way and most informative way possible and i think the the same thing can be said uh for the british authorities uh that that's as much as i can say at the moment and i also think this is bill callen again i also think this question relates to the first question namely who is going to be willing to embrace challenge trials and i would say the answer might look very different in three or four months than it does today i think uh we we're all hopeful that perhaps one of the very first vaccines tested will succeed whether it's oxford pfizer or moderna and so there's a i won't call it a honeymoon but people can imagine a path where a challenge trial might not even be needed uh but if in three or four months it becomes clear this is much more difficult than we thought it was going to be i think many more people will start to think about the need for challenge trials and the language in the open letter i think was very important and very careful it called for immediate preparations for challenge trials because you can't do these things overnight so i'd rather prepare in case we do really need these trials in the future and be pleasantly surprised perhaps that maybe we got an answer the old-fashioned way with one of the first vaccines currently being tested thank you for that answer are there any other questions from press yes please um one of the reasons as i understand it the moderna is choosing not to use human challenge studies is that uh there's been the experience for it from a gene therapy study from 20 odd years ago when somebody actually one of the subjects actually died uh how great are the risks obviously we're in the situation where a lot of people are very vaccine hesitant how do you go about dealing with the risk that a human challenge study could ultimately put back not just the cause of this vaccine but maybe even persuade large numbers of anxious parents against measles and so on is that a valid concern in your opinion and how would you uh how would you deal with it well this is sorry kaplan the uh hey the death in uh the university of pennsylvania gene trial of jesse gelsinger was actually not a challenge that it was a phase one um and they're done uh you know with uh new drugs trying to be careful and new therapies but there's always risk in both challenge studies and phase one studies i find myself sometimes thinking that those who object to the risk involved with a challenge study are going to have a hard time also accepting phase 1 studies because they they can be risky despite prior animal work and lab studies i do think it's important to stress that uh something that someone said earlier you get sound data when you have people in a place and you observe them and you know what they were like before what they're like post vaccination what they're like post exposure to the agent one way to reassure a nervous public which keeps hearing about speed speed speed is that you have very strong data out of the challenge study because it's highly controlled there may be dropouts from the big 30 000 person studies we may have you know despite the fact that we want diversity in different kinds of people in these studies it may not be easy to generalize from a mixed group early on as to what the safety profile is so starting with a small group control group and then expanding it out i think actually gives you more trustworthy data so it's not just speed it's to me it's partly being able to really understand what's going on i have one more question as well um in terms of if these challenges or challenge trials are approved as to where they would take place if oxford is to green light it can the trials take place in the united states or do you need fda approval in order to conduct the trials in a different country and um also are you guys i mean the big conversation around the pandemic is is the fact that we weren't prepared for this are you guys surprised by the lack of preparedness when it comes to the challenge trials isn't the first time that a challenge travels taking place um are you sort of surprised by the lack of again preparedness and and where we are a couple of six months into this still debating this question well again a study a clinical study carried on in the u.s with a product made in the u.s must pass the fda uh and your your second question was about uh what what what was it again preparedness uh preparedness for uh getting i i'll jump in over stan and just say i'm a little surprised that we haven't begun preparations for a challenge uh trial as uh bill was saying you know there's nothing lost in getting ready we can still debate whether we're gonna do it but uh you know i think many people who thought we might not get an answer or a successful answer on the first couple of candidates you want to be ready to move quickly and yeah i'm a little disappointed we're not preparing i mean i hear stan has heard we've heard there is some preparation now but i think we're a little slow on that and remember let's say the first five agents fail you're going to be in the standard modality recruiting 30 000 people per test vaccine again and again and again that you really want to be ready to go i think with an alternative even to debate the alternative but be set up to do it i agree but i think you know this is rich roberts i mean i think one of the things that we've already learned from this pandemic is that we've been pretty much unprepared um for every aspect of it so far and so i don't find it surprising that this has come as a big shock to people that all of a sudden one might want to do a challenge trial you know if the fba if the fda had been on the ball and if the administration had been on the ball we would have been doing testing mass testing a long long time ago we had the test they're available but the fda were very slow to approve them and there was no pressure from the administration to speed things along so i i'm really not surprised i'm going to add this car to holloway and go back a bit to that question about the early the jesse gelsinger child which art appropriately notes was a phase one study and the importance of although i generally don't like the term health literacy but the importance of what we're seeing today is the literacy around vaccination and the politics that have been attached to that one of the reasons i'm a signatory to the letter is because i i have written about clinical trials and and um disparate impacts and am very concerned that that lack of literacy and the politicization of this moment does not interfere with a person's autonomy and ability to sign in sign onto this kind of trial but it will depend greatly on our own ability to adapt our literacies to the moment and not to ignore the political reality that we're facing the public that is consistently misinformed about vaccination anyway and to move to this stage gives us a particular well challenge can i say and i think that um the more kinds of people like me a long literature professor um who's written about this kind of thing but from a completely different ethics perspective um have a chance to give a diversity of views in this perhaps we can address this literacy problem that makes people go immediately either to the gelsinger or the tuskegee trial is something that is going to inform this moment when it should not yeah and i'd like to um yeah to follow up with with the really smart remarks that carl made about um vaccine literacy and education and vaccine hesitancy and you know i think that the challenge studies which are something that um i think are going to be and have been very public and publicly notable i think this is a real opportunity to teach the public about vaccination um in an attractive and sort of charismatic way and i know that the the 30 000 people who've signed up for one day sooner you know i know that many many of us feel you know an opportunity here to educate the public and want to be educating the public and want to be champions for for vaccination um i think this is an opportunity for that and i think you know the the idea that i mean obviously we we hope and given what the you know the data about risks are expect that no one would would die in a challenge study but it is a possibility it is a real risk and it would obviously be tragic um but you know obviously that's that's logically um shouldn't make people more hesitant to take vaccines and the idea that um you know any bad outcome that ever happens anywhere related to vaccines in any way is going to cause greater vaccine hesitancy i think that's a you know overbroad assumption especially if it's an assumption being used to say you know here's a method that would be useful but god forbid there's ever any negative information any way about vaccination i just don't think that's the the right stair to be thinking of and then i just wanted to also address this preparation question because it is something we've been thinking about um and we're actually just i was just talking to our research director about commissioning research about this um pandemic preparedness for the future as it relates to challenge studies and yes i think that you know of the many areas as rich said where we've been behind the curve both in the us specifically but around the world challenge studies is is one of them i think that whether you think that the challenge studies for covet are not a good idea i think it's clear that there should be a regular plan in place when there are new pathogens and where there are pandemics to get challenged material that's going to be be ready and have a protocol that can be proposed and then if you have something ready then you can make the ethical decision is this something you should go forward with or not but the reality is if we had been started preparing a challenge virus back in january or february and then been able to do a dosing study if we had wanted in let's say april um we could be testing vaccines now and it would be great to have a sense of if the vaccines that we were putting into 30 you know tens of thousands of people uh might actually work or you know or would actually you know if we had some evidence that okay there's going to be some ethics here or there's not that would have been you know a huge value and i think which everything everyone i think agrees with and so i do think that this shows both the need for greater preparedness now and treating the preparations with urgency now and then also creating a plan for future pandemics to prepare uh challenges and have a standard operating procedure for that that's as efficient as possible and you know also josh on the topic of scientific literacy and carla to your point there's a little bit of a catch-22 because the af the average person who's going to volunteer for call we'll call it a conventional vaccine trial who believes in science believes in medicine believes in vaccines is also likely to believe in masks and hand washing and all the other things we're telling people to do which we actually know worked reasonably well and so in a way that's going to be a headwind in terms of accruing the number of cases we'll need to see in the placebo groups so the irony is just as the young and the healthy aren't necessarily representative of the broader population the people on the conventional vaccine trials won't arguably be representative of the broader population well that's where i think the responsibility is going to come in to talk about in which ways we can generalize the information from this study to a larger population even though you're absolutely right we're almost preaching to the choir um but knowing that and acknowledging that i think the transparency of this project is critical and at every stage acknowledging the issue for example that you just brought up um is critical to the credibility of the of the challenge trial process in and of itself so whether or not these have been done historically correctly or incorrectly i think there's a way to think about this moment as a as a unique and idiosyncratic one as well hi i i have a couple questions first i mean just to be ask a very cynical question which is the virus is raging so badly in the u.s that may be not that hard arguably to conduct these phase three trials and there's going to be about five that are starting so i guess i want to ask in terms of limiting you know harm what you argue against those conditions that you know just you could sort of do maybe under normal conditions would be hard to get field trial but now it's not that hard so you know sort of what's the added value of human challenge trials and i'm also curious i mean i know one day sooner has a lot of material in terms of how much time it would save to have a human challenge trial but considering the rapid growth of uh kovit in the us like what are your currents or thoughts on how much human challenge would save time in getting a vaccine well i'll leave it to others to do the safe time thing but i think you have to understand i've been around recruitment issues the ethics of recruiting subjects to trials a long time and recruiting 30 000 people and having some drop out and decide they don't want to do it is no small task doing it four or five times in a row even with rampant outbreaks a lot of people just are going to think i'm not sure i want to be in an experimental vaccine trial until they if you will get more information there's a lot of hesitancy and data out there we all know these polls so that makes me nervous uh there are sub-communities that are very nervous about getting involved in this research as well so to me it's big numbers and then you have this i hope for uh possibility that maybe we'll tamp it down so we start in some part of the country and we actually get people to put on a mask and you know distance and uh do uh behavioral modification and we get the virus down i mean if you've been doing this four months ago you would have done it in new york so you know we don't know uh maybe brazil is a good place to start but you know we don't want to condemn those people to outbreak so it's big numbers is is my answer uh just it's tough to recruit and you do lose even people get vaccinated wander away it's it's it's tricky uh and i would just add to what art said by pointing out that uh that a phase three trial necessarily means that you're looking for disease and possibly death in the control group so phase three trials are certainly not safe because you when you enter you don't know whether you're getting the vaccine or or or the control and if uh one of the vaccines or one or two of the vaccines fail and the phase three trial is done and and there's no difference between the vaccinated group and the control group that's a lot of people who sick and perhaps die so my point is simply that phase 3 trials are not without risk and they they don't give as much scientific information as a as a controlled challenge trial and yeah um just to answer your question as well you know first um i don't think we should in the united states should give up on suppressing the virus like basically every other developed country has has managed to do and i think it was you know art made this point of of you know if you looked a few months ago it would have been in you know you would have done this in new york um and the same thing you know in england a few months ago oxford thought oh we can test this here there's high infection rates we'll have an answer by september but then suppression was was effective and the thing to realize is that um i believe that the pfizer and maduro vaccines both need booster shots and so you're talking about you know someone told me today maybe it's about two to six weeks or so to enroll the people in the study then it you have to do you have to wait a month and then do the booster and then maybe it's another month after that until the vaccines fall into effect and so you're projecting now months out what the infection rate is going to be and maybe it's the case that infection's gonna stay at a high rate in the us indefinitely um and you know but i certainly hope that's not the case and i certainly think the government shouldn't be you know counting on that being the case when making policy concerning you know it's its plans for clinical studies um so i do think you know i i think that the future is unpredictable and in some sense you know there's a way in which i want to say you know i hope that the the vaccine candidates being tested in conventional phase threes get great data very quickly um and that challenge studies cannot improve on that part of the process and might be able to improve on the products about coral to protection or might help be able to test different doses or test secondary vaccines so in one way i want to say i hope that's the case but it's important to realize that hoping that's the case means hoping for for lots of viral transmission which is obviously something that we don't hope for and that we should not be planning for um and we should have backups and i'm gonna ask just one more question that's not exactly human challenge really but just since there's so many scientific experts here i'm just curious you know vaccines typically you know either produce antibodies or they create t cells or they create other immune markers and i'd like to sort of like a brief understanding of sort of like what's the best strategy and which of the current vaccine candidates for doing that just i'm a layman here so well um somebody else may wish to answer that but with what i will say to you yeah i can i can help you stanley you're the big expert in the world but i i i can pick that out um so i mean laura basically we obviously don't have a coronavirus vaccine that's approved either for seasonal or cells once or sus 2 or mers but what we know based on animal challenges that typically the production is driven by a certain type of antibody called neutralizing antibodies so those are capable of just blocking the virus right there are other types of antibody that binds to uh to this and you know what is their role exactly in protection is yet to be determined and if they are important or not uh based on vaccine studies currently we know on covet 19 there is a correlation so the more binding antibody the more neutralizing antibody and then the hope is higher is better and then basically what the vaccine trial had done is compared them to uh people that had survived kovitz with different level of severity mild moderate severe critical disease and then compared those neutralizing antibody to to those that were convalescent so again we think based on the fact of current vaccine based on challenge model with this virus with others and then based on the fact that typically respiratory virus the vaccine had relied heavily on those neutralizing antibodies similar to influenza the vaccine is not great so antibody is a big part though we know actually there are other components of the immune system that are critical so that one of them is actually what is the type of uh interaction that's gonna happen with the t and the v cell to really move uh this immune response to the past possible one there are different types of immune response the ideal one we're looking at a th1 that's the one that guarantee that there is not an enhancement of disease um so this interaction of bmt cell can either induce a good t cell response and i can also induce a long-term b-cell memory response because that's key what we know from prior coronavirus infected people with stars and mirrors is actually that immunity decrease over time what we also know from experimental vaccine with coronavirus is actually the antibody decreased quite a bit after a few months so that's really kind of the we need to know the duration of protection of people that get naturally infected or actually immune from getting the vaccine thanks so much nadine um any any other questions from from journalists if if i may um two two questions the first i'm asking this mainly because this is a point that's out there in the debates so i want to give you the opportunity to respond to it there is the argument out there that there is so much uncertainty about what the coronavirus is how dangerous it is uh and obviously about any candidate vaccines that nobody can be informed enough even the bright you know very well informed people taking the volunteering to do these tests but they can give informed consent uh i would be interested in um just getting on the record what the response to that point is and then once after that it would be very useful i think uh if you could hear a little bit more about how this idea started how this many uh people had the idea to set up this group and uh have this much success with getting getting interest in it because it's a remarkable uh phenomenon that you're asking a lot of people to to be uh very public spirited and take a risk but the first question i just like to ask is is there any validity of the notion that it's impossible to give informed consent to uh to just such a challenge trial uh maybe i'll uh try and answer uh uh the the idea that that uh there should be no unknowns uh would they can inform consent for to be a subject of an experiment virtually impossible of course yeah when you when you volunteer you don't know if the intervention works and that's why they're doing the trial so there's always uncertainty um degrees of uncertainty so is the claim that there's a more uncertainty here well you know the the subjects can also be priced at that fact and once they've been apprised of everything that the scientists know then they've gotten they know what the deal is um it would of course it'd be desirable if if we could pin it down more but if you know it's not unusual at all for there to be many unknowns uh let me say a word also about the background here there is i think and uh maybe josh can speak um more authoritatively about this but uh in recent years there's been a remarkable movement uh that goes by the name of effective altruism which has uh in part been driven by some philosophers at oxford and one adherents all over the world at harvard there's an enormously active chapter undergraduate chapter of young people mostly young people who uh have decided that they should be more australistic than uh they might otherwise be inclined to be but also that if you're going to be altruistic it's your business to try to figure out how to be effectively altruistic because that's the point of altruism and so they they hold meetings uh where they uh it's sort of like going to a marketplace you know look if you i've got an intervention where you can save this many life years oh i've got one where you can do even more and so on and uh this is an outgrowth of that some of the people who are involved um both on the volunteer level but also on the advisor level uh have been uh involved in effective altruism uh there are people from effective altruism who have walked into transplant clinics and said look i've got two kidneys i only need one why don't you take one of my kidneys and give it to whoever you think would be uh a good recipient in fact i think one of those people is on this call right now and uh so it's not a surprise that um uh so many people jumped to the fore when this was announced yesterday thank you and and john before getting to your second question which i suspect josh and others are a better position to answer i mean one of the arguments that moved me is despite the uncertainties and unknowns i believe there are now some empiric data that would suggest that amongst the very young and those without pre-existing conditions that the risk of dying might be as low as one in ten thousand but let's say it's one in a thousand let's be let's be you know let's be pessimistic you know contrast that 1000 to the fact that if you were an american soldier who was sent into battle in any of a number of wars your chance of dying was about one in a hundred and frankly in some cases those soldiers weren't volunteers you know so i think you're right about the uncertainty but there are some empiric data starting to come in that at least maybe give us a sense of what sort of risk one is taking on in a quest to help your fellow man great yeah and i'll um answer uh both of those a bit so first on the uncertainty side it's yeah it's been interesting um you know kind of doing this work for the past uh i guess about four months now and you know on the one hand um we've learned a lot about the the disease and the um uh the empiric data about the disease and so we do have a lot more confidence of of what's the mortality what's the infection fatality rate um for young and healthy people um and so and that that rate has you know unsurprisingly gone down over time as clinical treatment has gotten a little bit more sophisticated for it and has more knowledge so you know when we started there was a piece that was published in lance infectious disease that found that in china um 20 29 year olds the risk of dying if you were infected healthy and unhealthy was about 1 in 300 which is coincidentally actually the same risk of dying the kidney daughters have um but then actually recently there was a piece published in science uh with data from france that found that 20 to 29 year olds again healthy and unhealthy that that rate is about 1 in 14 000 uh people dying right so we have and again that's healthy and unhealthy if you look at um just healthy people you know about something that the cdc for example has found that about 92 percent of people hospitalized uh in the u.s had for covet had at least one co-morbidity and so if you look at things like the rate of hospitalization you know we have we have pretty good data i think about how likely um or early sort of an upper bound of risk um for uh for both mortality and for severe disease and i think we can say you know based on the existing data not just from china and france but also from there's uh there's uh not peer-reviewed data yet but there's data from stockholm and geneva and italy as well um we can say the risk of death is is very likely to be lower than one or ten thousand um which is lower than the risk of kidney donation and lower than the risk of childbirth which is about one in sixty five hundred um and i think and this i um the numbers are not in front of me as much but i think that like the risk of severe disease for a 20 to 29 year old is prop who's healthy is probably something like one in a thousand or maybe a bit less now the thing that that is troubling um that that is uh we've learned more recently is that um there can be sort of medium term or longer term um uh consequences of of covet in terms of fatigue or neurological symptoms or all sorts of things that are not um necessarily you know correlated to we don't know how much connected they are to severity um and that is certainly worrisome and that is something that to be considered but i think um yeah i would i would definitely um point to dr kalin's point about you know that we and and to professor wickler's point that you know we we never know um all the the consequences you know certainty of all the consequences of our actions and that there's you know a lot of context where there's tremendous uncertainty like like serving in war um and then you know i so i'm one of those those people um who gave a kidney to a stranger that dan mentioned actually abe is is another one um and and i'll mention with that you know so on the one hand people have been donating kidneys um for more than 50 years now living living people have been donating kidneys um but actually you know when i donated i donated in 2011 and at that point um you know the best scientific data was that there's no increase in your chance of kidney failure um if you donate a kidney turns out in 2014 with more sophisticated epidemiological tools it turns out that your risk does go up it goes up by about one percentage point or you know from a basically a very low level um about point one percent to something like about one percent um so it's not enormous risk in absolute terms but you know it's you know no one before that it's not the case the people who donated before then that that was unethical for them to do so or that they weren't reasonably informed there was obviously uncertainty there's uncertainty when i donated that's fine um but even something that people have been doing for decades can have uncertainty and so i think that it's also you know i think that it's okay for people who are to be well informed about what those um risks might be even if we don't know the the percentage or the number of all those those risks and we allow that in a lot of other different contexts and the last thing i'll say about this is that i think it's important to realize that insofar as the the risk and the uncertainty there goes up the benefit also goes up right so it's obviously you know we certainly don't want to be in a situation just people who might who might be able to participate in this study of having a significant chance of longer-term harm but if that's the case that means there's all sorts of young and healthy people who are already having you know uh you know long-term harm now um and so everything that can be done to avoid that needs to to be done um and so it's it's not just a factor that affects the um the risk of the trial side it's also a factor that that equally affects the the need and the urgency of the trial side sorry i'll go ahead and go ahead maybe we can answer the question well i was going to say i just want to welcome professor abigail marsh to the call and serendipitously um professor marsh studies the psychology of altruism at georgetown and um professor march the question was from from john authors about um sort of just remarking on how incredible it is that so many people have decided to sign up expressing interest for a human challenge trial um and not to put you on the spot but i was wondering if you can speak about um in your studies about the psychology of altruism how that relates to the outpouring of support we are seeing right now for a human challenge trial absolutely um yeah so you know what's i think really remarkable in the history of kidney donation i'm sorry i had to chime in late here i was wrapping up another meeting earlier um but what's remarkable if you look at the history of kidney donation is that it was of course banned to donate a kidney to a stranger long after it was technically possible mostly because psychiatrists and transplant professionals couldn't believe that an informed sane person would ever want to make such a sacrifice for somebody they've never met before they basically didn't believe that anybody's values could legitimately encompass truly altruistic goals and only when i think it became a matter of desperation and somebody was willing to give it a shot um a transplant surgeon named reginald go i think at brown finally was willing to give it a shot did people believe otherwise um and the research we've been doing recently on all sorts of altruistic populations suggests that people who make sacrifices for strangers they just actually place more value on the welfare of other people um contrary to the sort of long-standing myth that the only kind of value a person can have is a fundamentally selfish value which is not true and so what we've been seeing um in the uh brief self reports from people who are signing up for challenge trials is that's exactly what's going on it's not that they're particularly insensitive to risk it's not that they're poorly informed it doesn't look like um it seems like they're actually people who care about helping other people it's very compatible with their values it's not that they're ill-informed that there's something wrong with them um so i think this looks a lot like what we've seen in the history of kidney donation thank you yes absolutely go ahead into that this reminds me i was on the um what was then the institute of medicine panel on deaf and daunt in america we did the last um publication on dying in america and my role there was to remind us as we look through the data that the public narrative is going to be within the story and even as we understand that people are going to be convinced you know by the percentages of those who might die or those who might have neurological damage afterwards the way in which this is told to the and explained to the public is the strength of the story that we construct around it so i want to make sure for example that altruism is not culturally constrained even though it may be a it may indeed be socially privileged um and to explain what that might mean so that all of us or all populations have um equal access to being altruistic or being considered altruistic so i don't want us to be overwhelmed so much by the data that we forget that the motivation for this for people um both in believing in the efficacy or the reasonability of a challenged trial as a participant or as a member you know i'm much too old to participate um but it's someone who has ended up being a signatory to the letter is because of the nature of how we can tell a story that convinces the public as i said earlier already tainted by a politic that is not to our benefit that this is a social good thank you um i believe we have time for perhaps one more question i want to this is laura parker at netgeo oh i guess i'm not turned on here oh you're we can hear you okay yeah there um given the speed with which some of the uh and this question may have may have come up earlier and forgive me for being repetitive i just got out of another media call um given the speed with with which uh the other trials are moving into phase three what are the where do things stand now with the human challenge trials just in terms of of does anyone think that that there may actually be one that actually happens and i if so is it still oxford who would be the likely place that would do it i mean kind of give me a sense of what what's actually happening on this at this at this point in end of july uh nadine or josh do you want to speak on this point yeah i think josh can fill in the details uh i mean great question it's it's exactly what we were discussing on the call just the importance of timing we feel will already er many days later in a sense here um so yes i think that there are efforts across the many private companies here in the us to manufacture a challenge study that that's under gmp and there are some discussions also at the institution here within the us that have a high level of biocomplainment to take that upon i think a little bit of the hesitancy obviously is with the just the regulatory hurdles with the fda with the local irb and you know this big responsibility of first to no harm but nonetheless we're affecting people with coronavirus uh i think the oxford team had expressed obviously the most interest in being a lead in that and whether the challenge stock would be made in the uk or in the us i think uh this is yet to be determined thank you yeah and the last um i think there was a previous question um that did cover that so i think maybe you can send you the recording and you can check that i i'll just make a bit of a different answer than was given there and one is that i'm really just kind of following on on something adrian hill at oxford um has has said about this that um challenge studies are uh are also a complement to the phase three studies and not a replacement for them because we can't necessarily assume that the exact dose um that's being tested in those studies or the vaccines that are being tested are going to be the final dose or the the best vaccine that's ever going to be developed and so having the the challenge model uh be developed and be able to be tested that's going to be really useful for things like you know perhaps testing different doses of an existing vaccine or different methods of delivery um possibly testing different uh adjuvants or sort of like a helper or kind of booster uh protein to go with with vaccines um those can be functions of challenge studies and also understanding um some of the science uh of you know how a vaccine is is working these so-called correlates of protection that's also going to be quite valuable for example that if we in our phase three can find that a vaccine is effective if we are also able to know the correlates of protection through a challenge study that might be able to help us prove its effectiveness in older or higher risk populations more quickly so you know yes i think there's a lot of reasons to say challenge studies still could um be be helpful you know just on the kind of basic efficacy you know getting efficacy faster than a phase three but they're also um complements and will be helpful and useful even if the phase threes go you know very well and get data very quickly thank you so we we are almost out of time i just wanted to squeeze in one uh more technical question that we've been getting from a fair amount of volunteers so in in our bi-weekly newsletter for one day sooner we uh do our best to provide resources for other opportunities to sign up for traditional conventional phase 3 trials to our volunteers and some of our volunteers have asked whether or not participating in a phase 3 trial let's say for moderna will necessarily preclude their participation in a potential challenge trial and this is a question i wanted to see if perhaps stanley had an answer to or someone else on the panel well you know uh once let's say that the phase three trial shows that the moderna vaccine uh does uh work uh and then as josh just just said there would be an analysis of what are the immune responses that seem to be protective then in a challenge trial you could test another vaccine to determine whether or not they achieve the same type of response and are able to protect against a challenge that presumably the um the modern vaccine uh will also protect against so um and and i and i could just add that once uh one or two vaccines are shown to be effective let's say in phase 3 trials it's going to be increasingly difficult to do phase 3 trials on other vaccines simply because people will want the vaccine that's already been proven and so that challenge trials which we've talked about is being something to do now to give us some scientific hints about what what to do they may prove to be useful in order to produce 7 billion or 14 billion doses of effective vaccines for the entire world population because one company is not going to be able to do that thank you dr plutkin um okay so we are at an hour and i appreciate everyone's time don't want to take up any more um and yeah in addition to expressing my gratitude for everyone taking the time to be on this call i wanted to say uh just again that uh many bodies who have written about the preconditions for challenge trials to take place have included public engagement as part of that and so beyond this being simply just an incredibly fascinating conversation and an opportunity for some i think amazing journalism i think uh well-informed journalism about challenge trials serves an important social function in informing everyone about challenge trials um so thank you everyone so much for your time i really appreciate it um and i will distribute this video to everyone that was in the call once it's done all right thank you thank you thank you thank you everybody thank you