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Topic: What's the latest on the Regeneron and Johnson & Johnson trials?

Journalists and editors are invited to attend this live virtual event and ask questions either on camera or we can relay your questions to the panelists. Register to attend and receive the on-demand recording after the session is concluded. 

Panelists:

• - Allergy & Immunology Specialist - University of Miami Miller School of Medicine. 
• - Infectious Disease Specialist - University of Miami Miller School of Medicine.
• . -  Infectious Disease Specialist, Professor in Clinical Medicine at University of Miami Miller School of Medicine.
• - President  - AMA

When: Wednesday, October 7th, 2PM-3PM EDT

Where: 

This live event will also be recorded and transcribed for use by media and communicators after it is concluded. All registered participants will receive a copy of the transcript, so even if you can't make this event, we recommend you .

Thom: We have Dr. Susan Bailey – she’s president of the American Medical Association, thank you for joining us Dr. Bailey. We also have Dr. Jayaweera, he is an infectious disease specialist and professor in clinical medicine at the University of Miami, Miller School of Medicine, he is working on the Janssen Vaccine trial from Johnson and Johnson, so he's here to talk with us about that. We also have Dr. Gary Kleiner, he’s an allergy and immunology specialist at the University of Miami Miller school of medicine, and he's here to talk with us a little bit about the Regeneron Monoclonal antibody trial and last but not least we have Dr. Lara Beauchamps and Dr. Beauchamps is an infectious disease specialist also at the University of Miami Miller school of medicine, she’s got some recent research that she collaborated with the CDC.

Dr. Jayaweera, since the vaccine trails are what’s on a lot of people’s minds and where we are with those issues, so Dr. Jayaweera, could you tell us please about the trial that you're working on, the Janssen vaccine, what type of vaccine is it? How does it compare and differ to the other kind of vaccines that are undergoing trials and where are you with that process?

Dr. Jayaweera: Thank you, so the Janssen vaccine is adenovirus vector vaccine. So, there are multiple different platforms that vaccine manufacturers or researchers have developed for Covid-19 and this particular vaccine is using adenovirus 26, it’s a type of just a type of respiratory virus that we commonly see, but its genetically modified to have coronavirus part of the genome in it, so its genetically modified and what it does – and also, it’s a non-replicating virus. So, once you inject it, it gets into the cell and introduces this genetic material and then the immune system will recognise and produce antibodies. It is slightly different from some of the other vaccines, for example Moderna is a RNA vaccine and it has two injections, whereas Jenssen is one injection and Jenssen – one of the advantages of this vaccine is that their platform can have a rapid operationalisation and creating one billion vaccine doses over the next year. So that’s one of the advantages, provided the study show that it works.

Thom: Thank you Dr. Jayaweera, let’s go also now to Dr. Kleiner – tell us a little bit about the Regeneron trial and these monoclonal antibodies that are part of the treatment and how your trial is being conducted there at Miami?

Dr. Kleiner: So, we’re performing more of a prophylaxis trial for using two designer antibodies that are made by Regeneron. They bind to what’s called the S protein which is the protein that’s important for viral binding and replication and [inaudible 03:54] for infection. Most of the vaccine trials are actually working against making an antibody response to these proteins. These two particular antibodies bind to different parts of this protein and the main advantage of this potentially would be helpful for patients that either wouldn’t respond – either they have a problem with their immune system, something called the primary deficiency, cancer, transplant patients that may not be necessary candidates for a regular vaccine, this potentially would offer some benefit in protecting them. We’re performing a preventive trial there with this combination used for household contacts in the hope of decreasing transmission in these subjects.

Thom: Thank you Dr. Kleiner, I want to go next to Dr. Bailey – there’s a lot of talk and concern about the vaccine process and how safety as well as efficacy can be assured when there’s a lot of pressure to get a vaccine out as soon as possible. What is your position and the AMA’s position about helping physicians to promote more vaccine confidence among patients and the public as this hopefully rolls out in the coming months?

Dr. Bailey: The AMA believes that it is critical that vaccine decisions, therapeutic decisions are made based on science and evidence and not on politics, ideology or some sort of arbitrary timeline. We think it’s incredibly important for the FDA to be completely transparent about the parameters that its using to evaluate and approve vaccines and to let us know every step of the way as the approval process continues.

If physicians and patients don’t feel completely confident about the vaccine, there would be an increase in vaccine hesitancy which is already an issue and we can’t afford to make that worse. Physicians need to feel comfortable with the vaccine so that we can make sure that patients feel comfortable with it.

Thom: Thank you Dr. Bailey, last but not least we’ll go to Dr. Beauchamps and ask you to tell us a little bit about what you found patients presenting in the clinic who’ve recovered from Covid in recent months, but are now presenting with a whole set of symptoms related to an inflammatory syndrome. Tell us about what you’ve found.

Dr. Beauchamps: Yes, it was interesting to encounter patients that were presenting with a new unique syndrome. We were not very clear exactly what they had. We knew that they had a history of Covid a couple of weeks or maybe a couple of months previously, we came to find out that this was related to complications from Covid from their initial infection with Covid. These patients were presenting very similar to the already reported cases of multi systemic inflammatory syndrome in children that we all know were reported by the CDC and the majority of them were reported from New York City. So, they were looking very similar to those children and we then tried to figure out how they were linked and how different they were from these cases, so they were presenting with a very severe illness, so as you can see it was – we did an investigation and I came up with our definition in reporting, so that’s what I'm going to talk about.

Thom: Thank you Dr. Beauchamps, we’re open the floor up for questions for media who are on the call, I’d like to ask if you have questions please chat them to us and then we’ll call on you if you’d like to ask the question yourself, we’ll enable the audio so that you can address the doctors and ask the question, if you don’t want to do that I’ll be happy to relate the question on your behalf. I do have a question queued up here from Heather McKinsey, and Heather I’ll enable your audio if you’d like to go ahead and ask your question.

Okay Heather doesn’t seem to have her audio there, Heather is from Biospace, she did text her question to me earlier, I think the question would best go to Dr. Bailey – which tests are the best to determine current infection and why? So Dr. Bailey I know that you’ve got a lot of knowledge about the current testing capacity and the different kinds of tests, what would you say to Heather about the best test to determine current infection?

Dr. Bailey: The gold standard right now is the PCR test, the preliminary chain reactions test which involved the deep nasal swab, but it can take a day or two for the results to come back. Antibody testing is not helpful in terms of diagnosing acute infection. We only are recommending antibody testing in the process of community surveillance as part of the overall evaluation of a patient or if you're considering that patient to be a candidate for convalescent plasma. There are literally hundreds of tests that have been given, emergency use authorisation by the FDA, and I think time will tell which one of the proprietary tests is going to end up being the most reliable. There is a danger in a test being too good and diagnosing bits of viral fragments that are left even though the patient isn’t contagious yet. So, I think the jury is still out for which is the best test for any point in time.

Thom: Thank you Dr. Bailey – if any of the other panellists would like to weigh in on a question that I direct to any one of you in particular and you want to chime in on that, please feel free to wave at me or to chat to me and I will gladly call on you. Dr. Jayaweera go ahead.

Dr. Jayaweera: Yeah I think I agree with Dr. Bailey- the jury is still out, but in the current climate at the university of Miami at least, we manage to get a PCR done in about 4 hours and so we do have the capacity to get it done rapidly and there are tests which we can do in 15 minutes also but those are as Dr. Bailey said – the question was which is the most accurate – so it’s hard to say.

Thom: Thank you Dr. Jayaweera, next we’ll go to Charles Felix at South Florida Hospital 麻豆传媒, you have a questions about timing of the vaccine, I think Dr. Jayaweera can give some insight to that. 

Charles Felix: Yeah just wondering, Charles Felix with South Florida Hospital 麻豆传媒 and Healthcare report, right here in Florida. I was wondering the timing of your trials and when do you feel that it would be released at least on a limited basis, by the end of this year, beginning of next year, compared to the other trials that are going on, and going back to testing, one other thing to throw back into it, are there any tests available for home use that are kind of instant that you can kind of do at home without having to send to a lab.

Dr. Jayaweera: So, I’ll start with the first one, that’s easier – at this moment I don’t think we have but there are a lot of people developing those, including the University of Miami. One of our prototypes are currently with the FDA and it was developed by Sylvia Daunert, so that’s a test strip, but I think it will come, but at this moment there is nothing reliable for home testing, that is the ultimate goal of a research what we are doing.

Now, regarding the timelines for the vaccine, that’s a great question Charles. We just started the Janssen study, so the way it is – the sample size is calculated is that we have to enrol roughly 60,000 patients across the world, which include south Africa, brazil, India and united states and Europe and its placebo controlled, its randomised, so we don’t know who gets what, and then we look for points and the side effects and compare the efficacy and safety. Now, if we start – and we are one of the first sites to start, so some people started about 2-3 days before us, so it will take at least 10-12 weeks across the world to get to 60,000. So, we are counting say October, November, December we will have finished enrolling the subjects. Now the question is – we have to follow them for a certain length of time, maybe from 3 to 6 months, the study actually we follow them for 2 years, but we don’t have to wait for 2 years, we believe that by following for 3 to 4 months we will see a separation between the placebo and the study vaccine. So, I think March – April we may have some information, it’s hard to say, but the other vaccines are ahead of us – for example Pfizer, Moderna – they started about 2 months before. So, if there is a definite signal then they may come out slightly before us, so it could be somewhere from January to April I would say. The early information.

Thom: Thank you Dr. Jayaweera and thank you for your question Charles. 

I want to go next to Ali Gorman at 6ABC – Ali, your question involves question about President Trumps treatment in a report that came out today, I just want to make sure to clarify for everyone that the Doctors on our panel can’t specifically comment necessarily about a patient that they're not treating, but they may be able to give insight on this a little bit more generally. So, go ahead with your question.

Ali Gorman: Sure, that sounds great and thank you everyone for your time. This is probably for Dr. Kleiner and yes, we can’t comment on the president per se, but the report today says that he has detectable levels of Covid-19 antibodies. My question is – if a patient received the Regeneron Monoclonal antibody treatment, and then had an antibody test, would we be able to tell whether those antibodies are from the treatment or from the infection at this point?

Dr. Kleiner: So yes and no. so the company is obviously investigating what’s called the [inaudible 14:45] levels of antibodies in the subjects that are receiving the Regeneron antibodies. Prior serology or if a patient that has a previous Covid infection or has had some previous serologies that are positive, they're not eligible for this particular trial. So, I can’t give you an answer to your specific question, however in general the patients that are previous positive they would test positive, so that’s why those subjects are excluded for the trial, because it makes it more difficult to analyze the data in terms of the dynamics of how fast we’re using up the antibodies.

Thom: Thank you for your question Ali. We’ll go next to Julie Hernandez; Julie go ahead with your question.

Julie Hernandez: Thank you for doing this and inviting me. I have two questions, I was wondering how many vaccines are in the development stage, if you guys know – if anybody knows, and also, I was wondering, have you seen mutations from people and is it possible or how is anybody working on a vaccine for preventing any mutations so that people wouldn’t get reinfected.

Thom: Thank you Julie – Dr. Bailey would you like to answer that about the vaccines and about the possibility of reinfections with mutations?

Dr. Bailey: Yes, there are over a 100 vaccines that are in the preclinical stage of investigation. There are about a half a dozen vaccines that are in the phase III trials, three of which are going on in the united states, three are going on in other parts of the world and others that are in various stages in the pipeline. So, there's an incredible amount of activity that’s going on in this area which I think is just absolutely amazing. But all the vaccines that I am aware of address the so-called spike protein, the S protein that was mentioned earlier and I don’t think – and I would love to have the other panelists weigh in on this, that any mutations that we are seeing would necessarily affect the response to different vaccines, in other words – if the vaccine will still be effective. We don’t think that Covid is going to act like influenza does which mutates like crazy all the time, and that’s why we have to have a new vaccine for flu every year and they typically will contain 3-4 different strains. Covid doesn’t seem to behave that way, but I’d love to hear what my cohorts want to say.

Thom: Any of the other panelists want to add to that?

Dr. Kleiner: I just wanted to say that this particular trial has a combination of two antibodies, they're what are called non competing, so they're actually working against different parts of the protein. The theory of that is if the virus did mutate against one of them, potentially the other antibody that’s still in the cocktail would still prevent transmission.

Thom: Thanks Dr. Kleiner. Dr. Jayaweera do you have something to add?

Dr. Jayaweera: Yeah, I think Covid – as Dr. Bailey said, Covid is not one of those smart viruses that hides its receptive binding domain from exposure, so it is easier to create a vaccine for Covid-19 and also it will be extremely difficult for the Covid-19 to mutate and avoid the antibodies. So, we believe that even if there are mutations, still our vaccines would work. I mean most of the vaccines that have been developed, so yeah quite optimistic, it wouldn’t be – like Dr. Bailey said that like influenza where we have to keep manufacturing vaccines every year.

Thom: Thank you for your questions Julie. We’ll go next to Charlotte Libov, Charlotte go ahead with your question.

Charlotte Libov: Thank you for having these wonderful webinars. It’s my understanding that the participants in the vaccine trials will be followed for 2 months, what I keep wondering about is if two months is long enough for potentially serious side effects that aren’t that common to show up, what do you think a safe period is?

Dr. Jayaweera: It’s not 2 months, its 2 years.

Charlotte Libov: Well, but in terms of approval – 

Dr. Jayaweera: What I mentioned was that, in about – if you follow about 2-3 months, the signals may become compelling that one would be better than the other from efficacy standpoint, but then you have to follow them for 2 years to see what are the complications or whether these things would change. So, in general, I mean this is kind of extraordinary situation Dr. Bailey was saying, that there are many complicated factors affecting our vaccine research, but if you go in a traditional way, we would take at least a year to get the proper information. But having said that, it is possible that the vaccine may be so effective compared to the placebo, that the data safety monitoring board may say, there's clear evidence that the vaccine works as compared to the placebo. But that answer, nobody knows.

Thom: Thank you for your question, Charlotte did you have more to add to that?

Charlotte Libov: Yeah, I'm talking about the side effects really, the safety more than the efficacy.

Dr. Jayaweera: That’s a great question, I think the Oxford vaccine was halted twice for neurological disturbances, one was finally found to be multiple sclerosis which had nothing to do with the vaccine, the other case was a neurological condition they didn’t disclose too much, so these are the things that we are watching. So, the way we do things, for us safety is the most important thing. Efficacy is important but safety is even more important.

Thom: Dr. Bailey is there is anything you’d like to add to this, both about Charlottes question and as well as the discussion of safety and efficacy, both of those things kind of always get talked about together. Charlottes question being about concern about side effects and how long that takes, what are your thoughts about that?

Dr. Bailey: Well the two-month time period that we’ve heard about, I think in a lot of people’s minds is a bare minimum of how long people need to be observed after the 1 or 2 doses of vaccine are administered in terms of efficacy. Safety – it is an ongoing process and you're completely right, the less common side effects we’re only going to detect when large, large numbers of patients have taken the vaccine. I am not aware though of any side effects signals that are starting to fall out regularly in any of the trials and there are already tens of thousands of patients that are enrolled, but you're right – the two have to go hand in hand. A safe vaccine that doesn’t do anything isn’t helpful and a vaccine that works but has horrible side effects isn’t going to be helpful, that goes hand in hand and we have to have both.

Thom: Thank you Dr. Bailey – we’ll go next to Heather McKinsey from Biospace –

Heathers question for Dr. Beauchamps – can you tell us about some of the symptoms that people should be watching for in this long-term inflammatory syndrome, what are some of the signs?

Dr. Beauchamps: Yes, so I’ll talk about how we discovered these cases here in Miami, of course they were also being presented in other states and also in United Kingdom as well, actually that’s one of the ones that was reported. So, basically these patients were presenting, not with a pneumonia like we always see, these people were presenting with pneumonia and hypoxia, they can’t breathe, they have to be on a mechanical ventilation and they're just very sick and they can say that they were exposed to somebody very close, so that’s what we are usually – we see this every day, our bread and butter these days. 

So these cases were presenting with very severe symptoms of multi organ failure, they would be coming with acute heart attacks and strokes and they were coming with kidney function that was severely affected, they were telling us that they had history of Covid a couple of weeks or up to three months ago actually, so when we – to begin with these patients, everyone was tested with a PCR in the ER and their PCR was negative, so we were not suspecting Covid, then upon investigation we saw that they had Covid before. So that’s when we started using the antibody test and we analysed and measured their antibody test and we saw that their antibody test was very high. So, all of these patients had evidence of previous infection. In one case that had pneumonia, we even had to go and do a whole genome sequencing of samples from the respiratory cultures to actually show and prove that they did not have the virus itself. This syndromes are presenting and is a result of huge humongous inflammatory response that is happening weeks and even months later. 

We don’t know exactly what is the cause of it, but we think that it might be related to maybe post infection development of blood clots everywhere that could cause anonymous involvement of many different organs. So, this is what we think it could be, but actually right now we need to do more studies and analyse exactly what is the cause. We have seen that in some of the cases that were reported in the CDC report, they had an autopsy, and that’s what I'm saying that they had evidence of micro clotting in many different organs, including the brain – so this patient presented with [inaudible 25:51] Encephalopathy, so they just presented with many different symptoms, except pneumonia and they were placed on mechanical ventilation, but it wasn’t because of that Covid pneumonia that we always see, so it’s definitely a different syndrome that acute Covid – and it really resembles the syndrome seen in children and that’s how they were reported, having been exposed to parents or had actually Covid before and presented a couple of months later, it’s something that we have to make sure that we can tell our patients now that we are seeing and starting post Covid clinics, to make sure that they come to us with the beginning of the symptoms and not think that – oh I already had the infection so I needn’t worry about it – the sooner they can get to us so that we can provide with care, the better, but there’s a lot of questions we have to answer. We just saw the cases, reached out to the CDC and they were kind enough to involve us in their discussions with other colleagues all over the world and united states and that’s how we collaborated with them to report the 27 cases that you saw reported on Friday.

Thom: We have a question next from Tina at Science 麻豆传媒 that I think is a good follow up for Dr. Beauchamps and then also you had a question for Dr. Jayaweera, please go ahead.

Tina: Hi, so actually I had a couple of questions for Dr. Beauchamps, first of all, can this inflammatory syndrome appear in people of any age or is it limited to teenagers and young adults?

Dr. Beauchamps: So, all of the patients that we’re actually reported in this MMWR report, they were all from 21 to 50 years old, so they were very, very young. Majority of them have been like that in their 30s and 40s, there are patients that we had here in Miami who were 46 and 5-, but I have seen syndrome again in people that are 60 – we had one 60-year-old and a 65-year-old as well, but from all the reports we saw that they were pretty young. So, the majority are in between 25 and 50.

Tina: And do you have any concerns that any of the vaccines might produce these inflammatory syndromes weeks or months afterwards?

Dr. Beauchamps: We cannot say, we don’t know if the amount of antibody is related to the development of this syndrome, we really don’t have an answer to that, so we really don’t know if the creation of antibodies from a vaccine will definitely be linked to this syndrome. We really think that there is a lot more to that and it might not be just the actual antibody itself but just the way that the body is responding, really, I'm just trying to elucidate couple of the possible causes but there is nothing linked the antibody production, the quantity or the type that is linked to this. Right now, we don’t have any answers to this.

Tina: And one more, there's been a report that some people develop auto antibodies against interferon or against tissues in their own bodies after Covid. Is there any sense that that might be going on in these inflammatory syndromes?

Dr. Beauchamps: Yes I mean we also had that thought, evidently we haven’t been able to determine very specific auto antibodies that have been developed, but in some of our patients that we have seen, they might come with other complications like maybe drug use and other comorbidities and sometimes the history of infection with Covid together with these comorbidities and activities that they do, might come together with – put together real important bomb together, because they could actually develop antibodies to let’s say the blood vessels or it could be also to parts of the body and that’s when you can see autoantibody production, but definitely I think there might be a trigger from Covid itself that is something that we just don’t know right now, maybe genetics that is just causing this. Autoantibodies that we have seen have been linked with other conditions that the patients had and they just flourished like when they had the infection. So, it was a bad combination with their history and their activities and then it all came together to produce massive strokes or heart attacks and severe liver failure so these presentations are very severe striking, not what we see on a regular basis. I really think we have to do a lot more investigation to determine and measure these antibodies and see what is the prevalence and maybe try to find out who are the people that are principals to have these autoimmune responses after infection.

Thom: Great thank you so much for your questions there for Dr. Beauchamps, Tina – did you have some questions for Dr. Jayaweera as well?

Tina: I did, I was wondering – you said that the vaccine that you're testing is only a single shot vaccine and I was wondering what happens if someone needs a booster shot and whether there are pre-existing antibodies against the adenovirus that’s being used and if those pre-existing antibodies do anything to affect the efficacy of the vaccine?

Dr. Jayaweera: Thank you, that’s a great question. So, this was tested on people, this is phase III study, on phase I and phase II these concepts were tested and the pre-existing adenovirus antibodies would not affect because these adenovirus also have been genetically modified to bring their efficacy effectiveness better. And previously having antibodies would not have affect, but the question – I missed the first – was there another part to it?

Tina: Yeah what happens if you need a booster shot?

Dr. Jayaweera: That’s a good question, so on the phase II they did try that, they did the one injection versus two injections and in fact the phase III they were not sure whether to go with one or two, but when the phase II results came, they realised that one injection was as good as two injections, so they went with one. In general, in vaccine world, one injection is much easier to operationalise across the globe.

Thom: Did you have another follow up, go ahead.

Tina: Yeah, I just wanted to clarify, is the adenovirus making the spike protein on it or is it just delivering instructions for making the spike protein into the human cells.

Dr. Jayaweera: Yeah it is delivering, it’s like a vector.

Thom: Thank you so much Tina, we have a question from Chen from Infectious disease and I think this would be best for Dr. Bailey, there was a study published recently in Jamma, in Tennessee that found a decrease in antibodies after 60 days among healthcare personnel, this seems to go along a little bit of what Tina was asking of Dr. Jayaweera, can the antibody effect of the vaccines wear off in a relatively short amount of time? Do you know of any data about that and any thoughts Dr. Bailey and any other panellists?

Dr. Bailey: Yeah, I’d love for everybody to weigh in on this one, we really don’t know the corelation of antibody levels and immunity to getting the infection again. There is a lot of work going on about this, I think there’s pretty universal agreement that antibodies that are made as a result of natural infection do tend to wane after a couple of months, however antibodies are not the only things that protect us against Covid-19. There are T-cells and other parts of the immune system that are not as easily measured and that can also help give us immunity, so we really don’t know what antibody levels mean in terms of susceptibility to get infected again.

Thom: Dr. Jayaweera, please.

Dr. Jayaweera: Yeah absolutely right, I think what has happened is that we are so much into these neutralising antibodies, the neutralising antibodies are the ones that will neutralise when the virus comes in and then it binds with it then it neutralises it, but as Dr. Bailey said, there is so much more happening behind the scenes with the T-cells that cause antigen presenting cells and t-cell activity to wipe out the viruses as they come in. so, the way the study is designed, once we vaccinate, we check the antibodies at day 29, at day 70 and then at 6 months, 12 months, 18 months, so we are going to track antibodies and we will have an answer. Whether these things what we say are really true, because we will know the antibodies titers and we will publish it, so that everybody knows whether the antibodies fell off or whether they maintained reasonable length of time.

Thom: Thank you Dr. Jayaweera. We have time for one more question here that Dr. Bailey can weigh on, because I know Dr. Bailey you have a hard out, so I wanted to give Kylea at Miami Today an opportunity to ask her question because I think Dr. Bailey might have something to say about that as well as Dr. Jayaweera.

Go ahead Kylea.

Kylea: Sure, and what I was wondering is that a few reports have come out recently that people participating in the Moderna trials were experiencing some severe side effects and what I was wondering was if there’s any particular threshold of what percentage of participants can experience some sort of side effect or even severe side effect before the trial or production process to be either effected or stopped.

Dr. Bailey: Boy! That’s kind of the 64000-dollar question. I personally have not heard about side effects from the Moderna vaccine. It is a new type of vaccine that and the Pfizer vaccine or MRNA vaccines which have never been in widespread use before and so we’re looking very carefully at side-effects, but it depends on what the side-effect is, its very common for patients with other vaccines to develop a fever, sore arm, they may briefly break out in a rash, get a headache, feel like garbage for a couple of days and so I wouldn’t anticipate that even a high number or high percentage of that type of side effect would be an impediment to a vaccine approval but I would think that a more severe type of reaction, we would have a much lower threshold in terms of approval, but everything is going to have to be done on a case by case basis. 

Thom: Thank you Dr. Bailey and with that we’re going to let Dr. Bailey go cause she has another obligation to get to, so thank you so much for joining us Dr. Bailey and if any media on the call have follow ups that you’d like to send to Dr. Bailey, we’ll make sure to send along with the video and transcript, the contact information to the communicators there at the AMA who can get your question to Dr. Bailey. Thank you so much.

Dr. Jayaweera, would you like to weigh in further on Kylea’s question?

Dr. Jayaweera: Yeah, so if you look at the phase I, phase II studies, the way the FDA wants us to capture is that any side effect is captured as an adverse event. So, if you say that your arm is sore it’s an adverse event. I mean as Dr. Bailey said, if you stick a needle in your arm, it’s going to be sore and then if you have slight feverish, slight arrythmia, slight anything is captured. So, I saw Moderna – the newspaper report, but if you look at most of the things that Moderna has, they were nothing significant – they were having fever or chills, those are pretty much expected. So, if you look at the side effects profile for all the vaccines, Pfizer, China vaccine, oxford, all the vaccine candidates, they all have a similar proportion of side effects, 70 to 80% having something, some discomfort somewhere. But what the real issues are – the dangerous side effects like neurological problems or some other major side effects, and those are the ones that make a vaccine candidate be discarded. So, the threshold is based on the severity and the frequency. Not just the frequency.

Thom: Thank you for your question Kylea. Next, I want to go to Daniel Revero, I don’t see Daniel in the meeting now, so I’ll ask te question for him, Daniel is wondering about the inflammatory syndrome report from Dr. Beauchamps, is there any idea of the prevalence of this locally and what should the public, especially people who have tested positive in the past know about this? 

Dr. Beauchamps: Yeah, we really don’t know the prevalence so far, we just recently discovered that this was happening a couple of weeks ago. The hospital UM in Jackson [inaudible 4118[ have had a handful of patients that have been confirmed. We had many other ones that were coming before we could do antibody testing in the hospitals, so we just don’t know if those were actually part of this multi inflammatory syndrome or not, so we were able to identify these persons with the symptoms only when we were able to pair it with the antibodies, so that was only – I think in the month of July, so we just have a couple of months – two months of being able to recognise them. Every week that I go to the hospital, I have one or two cases. The majority right now are presenting with neurological symptoms, they're presenting with encephalopathy, they cant really think well, they have headaches, they cant communicate very well, so they are in coma, so these are the patients that we’re seeing and right now there’s no real answer to those and how to treat them, we just treat with steroids like we usually treat people that are coming with auto immune disorders. We are definitely not able to quantify what is the prevalence, the exact prevalence right now, but from my experience, every time I go, I go for a whole week, I see at least 1 or 2 cases that are presenting with already antibody positives before, with a new presentation. It might not have all the criteria that was said by the CDC, but at some point, it will have one or two of those symptoms that were there, so we classify it as such.

Thom: We have another question I think for Dr. Beauchamps from Terry Brava- 

So, Terry asks – have you seen any association between the inflammatory response and patients who suffer from migraines, arthritis, MS or other inflammatory issues. Is there comorbidity with those things or differential diagnosis going on?

Dr. Beauchamps: That is a very good question, the patients that we have seen presenting with like I said coma and not being able to communicate, they have had high incidents of prevalence of lupus, so autoimmune disorders that they know already, patients that already are taking hydroxychloroquine or other medications for arthritis and like that, and interestingly in the two patients that we presented and reported to the CDC, they both came saying that something was hurting, I think their leg hurting for two months – some sort of aching somewhere. And, other physicians in the ER sent the marker for autoimmune disorders – surprisingly they were high, they were positive and they didn’t even know that they had that antibody there. So I think there’s a lot that we have to still study in these patients, but definitely they're coming, a lot of them with already diagnosed conditions like this or maybe we’re just ending it right there and we’re seeing that that test is positive for arthritis, inflammatory syndromes, that we usually see for lupus, arthritis, and such – so a very  good question, I think there is a relationship but I'm not sure.

Thom: Dr. Kleiner, what can you tell us about the Regeneron prophylaxis trail and what kind of typical transmission levels there might be with someone in close proximity within the same household to an infected Covid patient and how much would we hope that an effective run for this would show reducing that rate? So, what would that rate normally be and what are we looking to see it reduced by?

Dr. Kleiner: So we don’t have the data yet, there’s only been about a fifth of the patients of the roughly 2000 that are supposed to go into the trial be enrolled and treated so far, a normal transmission rate is about 10% in the same household, so from the other studies that Regeneron has done – more of a treatment, there’s been pretty significant data that there’s been a decrease in the viral loads in the patients that have received it, as well as symptom scores. This study will actually look at markers of symptom severity as well as transmission rates. In terms of efficacy, in terms of what percentage decrease – I can’t comment, that’s really up to the FDA in terms of approval, but the whole – the data so far in these  other trials has been quite promising so we’re optimistic that we will see some type of clinical benefit in the subjects that receive it.

Thom: I noticed that you referred to decreasing the viral load, so is that a situation where someone might still eb infected but have a more mild case?

Dr. Kleiner: So, yes and no – there are people that have – so most of that data is coming from the treatment studies, not so much the prophylaxis studies, there are patients – particularly young children who might have very high levels in their nose but have very minor symptoms, so the viral load doesn’t necessarily corelate with the symptoms. The studies try and capture both symptoms scores and virus quantitation, so as we learn more about the use of the medications, hopefully we’ll have better data.

Thom: Dr. Jayaweera what’s your number one concern for trust among the public about adopting a vaccine once one is officially approved and begins to roll out? And what would you say to patients to reassure them about the safety and efficacy and just that this process has gone through the right steps?

Dr. Jayaweera: That’s a great question, what you said was very true. There is a fair amount of distrust about the vaccine and that we are rushing through and that we will cut corners. So, I can reassure everybody that that is not the case, we will follow these patients very carefully for anything. Now, regarding the common question that I have gone is – is this placebo controlled? So, half the people will get the vaccine and half the people will get placebo, and so some people have asked me – why should I take part in the study because I may end up with a placebo, which is true – that’s the whole idea of doing the study – but on the other hand if you were to get Covid for some reason, and if you were in the study and you end up with placebo, very likely you will get a better healthcare because if you're on the study we give you a pulse oximeter, we give you a thermometer, we give – my cell phone number is there in the consent form, my team cell phone number is in the consent form and then we will come to your home and take care of you, I’ll bring you to the hospital, if you do come down with Covid-19. So that way – even if you get a placebo, you still get better care. Regarding the suspicion about the vaccine, I think one has to feel comfortable that academic centres like the University of Miami or the other major universities are taking part in it, and the FDA has their own mandate, so therefore we will make sure that science will follow the approval and the patients will be monitored very carefully by people like us. 

Thom: Thank you Dr. Jayaweera. We have time enough just for a few more questions, if anybody in the media on the call ahs a question please chat them and we’ll try to get them in. I’d like to ask Dr. Beauchamps, not related to the study that you did about this inflammatory syndrome but more about what your normal role is there at University of Miami Health, you're not usually working on this kind of disease – you work mostly on HIV and STD’s and tell us about how that process has gone where you got recruited to work in the clinic because of the need for more physicians and that led you towards the path of working on this paper.

Dr. Beauchamps:  My passion evidently like you said is HIV research, HIV prevention research and STD’s in general. Also, the healthcare of the gender and ethnic minorities. So this is a pandemic so evidently we all had to be there available in the frontline when this happens and it has been an interesting journey trying to take care of patients with a disease we just never knew about, but definitely had to say that I have learnt a lot about this disease and it’s not that I'm not happy doing it, of course I've gotten very, very interesting cases and I've done my part, my duty of taking care of patients, being there for the family members and going through this process of reporting and making sure that we can identify the ways that this virus is effecting everybody, but yes – I have passion for other viruses, but we’re all here at the front line

Thom: Thank you Dr. Beauchamps, we’ve heard that story time and time again of doctors from different disciplines or specialties joining in the fight against Covid and its quite interesting to hear what your experience has been like. Dr. Kleiner what would you say to patients and the public about access to the Regeneron treatment in the future, when and if that gets approved. What should people know about how to go about learning about that in the case that their family member comes down with Covid when this is available.

Dr. Kleiner: So the company – one website that’s very helpful for any patient with any disease is actually clinicaltrails.gov – you can search by disease and look up places that are performing different types of research, not just for Covid, any type of disease that’s NAH funded or regulated by [inaudible 51:57] so people can either go to Regeneron website, clinicaltrails,gov to see the centres that are participating, this particular trails, and international trails – it’s all over the world obviously, but in terms of availability, once its approved, if it shows efficacy then I'm sure that there will be information sent for this as well as the other vaccines that are being tested about how it can be obtained. But I would say clinicaltrails.gov is probably the best source for the consumers or other people to look up information quickly about particular diseases.

Thom: Thank you Dr. Kleiner – we have time enough for one question for Dr. Jayaweera and I’d like to call on Kylea at Miami Today – go ahead Kylea.

Kylea: Thank you, Dr. Jayaweera you just mentioned that participants in the vaccine study may receive better Covid care than they otherwise would have, so I'm curios what efforts are being made to ensure the participants are representative of the larger community and particularly of lower income communities which are statistically more impacted by the virus but already has access to less healthcare.

Dr. Jayaweera: That’s a great question, that is exactly what we have been thinking about. So, we are making all efforts to recruit the people who are at risk and who are vulnerable and who normally don’t take part in a clinical research. In particular Hispanic and African American are the two groups, mostly African American because in Miami it is not that difficult to recruit Hispanics, but definitely African Americans and the people who are low socio-economic groups. So we are going to churches, we are messaging to the community groups and boards to help us to recruit them and we are messaging through different social media and we want to make sure that at least 25 to 30% of the people who enrol are minority and African American – I hope we will be successful but we are going out of the way to recruit them and if the media can help us, that is the best thing you can do for this study.