 Okay, I guess we are ready to get started. Good evening, everyone, and thank you for joining us for Navigating IBD and COVID-19. I'm Erin Rommel with the University of Maryland Medical Center. Our moderator today is Dr. Raymond Cross, professor of medicine at University of Maryland School of Medicine and director of the inflammatory bowel disease program. Before we begin, I have a few housekeeping items. Please submit your questions anytime during the presentation, and the physician team will answer them at the end of the presentation. The seminar will be recorded and an email of this recording will be sent out next week. Thank you. I now turn this over to Dr. Cross. Thanks, Erin. And before I introduce my colleagues, I just want to thank everyone for attending. It seems like in the COVID era, we go from one Zoom or Teams or go-to webinar calls. So giving us an hour of your evening to go over these important questions, we really appreciate it, particularly with the nice weather. I'd like to introduce my fantastic colleagues, Sima Patil, Yunyi Wong and Lauren George. They're all faculty at the University of Maryland School of Medicine and also clinicians in our inflammatory bowel disease program. And they're going to be participating in the discussion tonight. So there's many, many questions about COVID and we thought that having a webinar, we could address some of those questions and give you the best evidence to answer them. So as you know, COVID-19 originated in Wuhan, China in December of 2019. The symptoms of COVID are typically food-like symptoms, which can occur two to 14 days after exposure. They include fever, cough, shortness of breath of the hallmark symptoms. In addition, I'm going to show you some evidence that GI symptoms are fairly common in patients with COVID infection, particularly those with severe COVID infection. They include diarrhea, nausea, vomiting, and of course we've learned that COVID infection can result in loss of taste and smell. And the spread is mainly through aerosolized respiratory droplets. And that's the, you're all familiar with the structure of the spike proteins of COVID-19. So I was alluding to this already. This is the frequency of patients, of symptoms in patients in China in the early days of the pandemic. You can see that about half of patients have respiratory symptoms only. Another half have GI and respiratory symptoms. And a very, very small percentage of patients have GI symptoms only. This is important for a Crohn's and Clitis audience. If you're having only an increase in your GI symptoms, it is statistically unlikely that that is due to COVID-19 infection. It doesn't mean you don't call the office to speak to one of us to help clarify, but typically you're gonna have respiratory symptoms with the GI symptoms. And on the far right, you're seeing another study looking at hospitalized patients with COVID. And you can see that about two thirds of hospitalized patients have GI symptoms in one form or the other. Most commonly are loss of appetite, diarrhea, nausea, vomiting, abdominal pain, less common and weight loss in less than 10%. So for those of you that haven't heard of the secure IBD registry, this has really helped us as clinicians manage patients during the pandemic. It's a registry where physicians, nurses, advanced practice providers submit information on patients with Crohn's and Clitis that have a COVID-19 infection. We provide details about their comorbid medical conditions, age and importantly what medications they were on at the time of infection. We also of course submit information on the outcomes of the patient. So you can actually type in secure IBD registry and the data is updated regularly. So you can see the impact of various medications on outcomes. The demographics at the time of this publication was about 60% of patients had Crohn's, about 40% had all sort of colitis. Most of the patients at the time of infection were in clinical remission, but there was about one in five patients that had moderate to severe disease activity. And importantly about a third of them experienced an increase in their baseline IBD symptoms. So those that were symptomatic had worsening, those that were in remission had new onset symptoms during their COVID infection. Again, diarrhea was very common, less nausea and vomiting in IBD than the other study I showed you. And overall, this is about twice as common compared to patients without IBD that are infected with COVID at the time of this publication. Now a little bit about vaccinations and cases. So unfortunately there's been nearly 30 million cases, documented cases of COVID in the United States with over 500,000 deaths, which is really staggering. We reviewed these slides on Wednesday morning and at that time we estimated that there were 75 million total doses of vaccine administered and over the last day and a half that's approximately 90 million. So the progress in vaccination is really accelerating. The table on the bottom, I didn't label it very well, but these are the numbers from the vaccine trials for the Pfizer and the Moderna vaccine. You can see that there is over 70,000 patients that were in these trials, which is an enormous number. And you can see the COVID cases on the third column in those that had vaccine versus placebo. And you can see clearly it to the vaccine prevents cases. And if you look at severe COVID infection, there was only one case reported in a patient receiving the Pfizer vaccine. So protects from COVID infection and certainly protects from the severe COVID that we worry about. So now I'm gonna incorporate my colleagues into the discussion here. That's sort of our warm-up to get everyone ready to go. I'm gonna ask Sima Patil this question. So Sima, are our patients with Crohn's and colitis more likely to get COVID or to develop severe COVID complications because they have Crohn's or colitis? Thanks Ray. So from IBD in and of itself does not increase your risk to get COVID infection and also does not increase your risk for severe COVID disease. So in having inflammatory bowel disease in and of itself shouldn't increase your risk. Great, thanks. I'm gonna give this to Dr. Wong. So Yuni, are patients more likely to get COVID or develop severe complications of COVID if they're on immune suppressant therapy or biologic therapy? And I'm gonna pop some slides in here for you. Thanks Ray. So in general, majority of the medications that we use for Crohn's and colitis are considered safe to continue even in times of COVID. We haven't seen an increased risk of complications from COVID infections in our patients that are on biologics or immune suppression. By and large, corticosteroids like prednisone has been shown to carry the highest risk of complications from COVID infection which emphasize the reason to maintain on therapy including biologics and immune suppressants that are maintaining the disease and remission in order to avoid flares that would require corticosteroids. Yeah, I agree. Now, we were talking about this a little bit this week. So for the patients out there, does that mean if they're having a flare that they shouldn't take prednisone? I think that it's gonna be case-by-case scenario. As healthcare provider, we're gonna always weigh the risk and benefit with each individual patient if their disease is severe and active, quarantining control of symptoms then corticosteroid is indicated. But this is a time for us all to reconsider when corticosteroid can be taper and minimize the usage of it which we always try to do anyway with all of our patients at the University of Maryland. Our goal is to minimize usage of corticosteroid while finding a medications that can maintain remission. Yeah, I agree. And one of the... I should have labeled this a little better for the patients that are attending. So I'm using terms that I shouldn't be using. But anti-TNF is drugs like remicade, umera, simzia, symphony, six MPNAs, the thioprine, or macaptapurine, or imurine. Anti-integrin is in tivio for those patients that are on that drug. The anti-IL-12-23 drug is stylara. And then the only jack inhibitor that we have for ulcerative colitis treatment for IBD in general is Zeljan. So if you're looking at the column on the far left, those are the drugs that we're talking about. One of the problems when you look at a registry like this is there's no group of patients that don't have IBD and or that aren't on these medications. So what is the base rate? Early in a pandemic in New York City, the hospitalization rate was about 16% or so. And about half of those patients were in the ICU. So 8%. And once you made it to the ICU, about two thirds to three quarters were on a ventilator. So that's 6%. And then once you were on a ventilator, back in the early days of the pandemic, the mortality was about 90%. So 4% or so. So if you look at those numbers, if you just sort of remember 16%, 8%, 6%, 4%, looking down that column, it's very, very reassuring. Maybe you can get a sense that patients that are on immune suppressant oral therapy have a higher hospitalization rate. But if you look at some of our medications like Remicade and Stelara, the numbers are incredibly small and almost giving you a sense that maybe these therapies can be somewhat protective against severe infection. We're certainly not starting drugs for that reason, but this data for all of you out there watching should be very reassuring. One cautionary note is that if you actually go to this registry and you see some of the other therapies, like Azacol and Pantasa and Leauda, those are going to be listed as 5-ASA or misalamine. You'll see that the numbers are a little bit high. Most experts think that that's related to poorly controlled Crohn's and Colitis and not reflected by the medications themselves because they're primarily oral therapies that aren't absorbed. If you go to the website and look at it, don't be alarmed by that. Let's move on to some additional questions. For Dr. George, Lauren, how is monitoring of my health impacted by COVID? As COVID impacted the way we manage our patients with Crohn's and Colitis? Thanks, Ray. That's a great question. Building off of what we just talked about regarding the importance of maintaining remission and staying on medications, it's equally important in management of your disease to maintain regular follow-up with your GI specialist and to move forward with any recommended procedures or monitoring. We understand that everyone is very concerned about safety during this time, especially until everyone is vaccinated. We have been taking a lot of safety precautions, including when you come for a procedure, universal testing of patients prior to the procedure as well as full personal protective equipment with all staff members and decreased patient volumes initially and room turnover times. We really are taking this seriously. There are non-invasive methods of disease monitoring that we can try to use if appropriate but endoscopy and follow-up visits with the physician are really hallmarks to maintaining adequate disease control. I'd say that this should not impact the monitoring of your disease. I agree. I'm much older than my colleagues here. Back when I trained, the focus was always on symptoms. If you felt well, we were happy. If you were off steroids, we were even happier. Over the last 20 or 25 years, we've really moved beyond that to where we're trying to be much more objective because we realize that there are patients with Crohn's and colitis that may feel well but still have underlying inflammation that's not being well controlled. Those patients are more likely to experience relapses of disease, to go into the hospital, to develop complications and to need surgery. Also, those patients are more likely to develop colon cancer if they have chronic colitis. Getting labs which may include blood work for the majority of patients and some patients that might be stool testing and in almost all of our patients, we're doing some kind of relook with a colonoscopy or sigmoidoscopy to at least make sure that the inflammation is better. Our practice, as Lauren said, has not changed that at all. Very early on, we were doing more of the blood work and stool testing than scopes, but even during the worst of the pandemic, our safety of doing the procedures was very good. We did not have any patients exposed to COVID or to develop any complications. You should continue to strive for those more objective targets of treatment so you'll have a better long-term outcome. Importantly, shouldn't be deferring colonoscopies because you can develop an interval cancer if you delay too long. Unfortunately, I've had one patient that that occurred in, so it's important that you keep up with your colonoscopies. Seema, Dr. Patil. Can, should I receive the vaccine? What can you tell our patients? Sorry about that. I would say overall, the answer is yes to both of those questions. So can you receive the vaccine? There is nationwide and international consensus from IBD experts and societies that COVID vaccination is safe and effective in patients with IBD. So we really are recommending that you get vaccinated when it is available to you. Great. This is going to go to Dr. Wong. Uni, which vaccine should they get? Pfizer, Moderna, J&J. So all three FDA approved vaccines that are in the U.S. are recommended. So whichever one that is available to you is the one you should get. Agreed. And this is going to be a follow-up to you, Uni. Do patients need to alter the timing? Do they need to do anything with their medications to receive the vaccine? And will they have side effects from the vaccine? Or let me rephrase the latter one. Will they have increased side effects of the vaccine? So to answer the first question, there is no recommendation to alter the medication to receive the vaccine. There's been questions about whether the vaccine would be less effective if someone is on immune suppression. We don't have data on COVID vaccine and titer just yet. However, in previous vaccine studies, we have seen that patients are still able to generate titers after receiving vaccines while on immune suppression. So these vaccines should remain effective even if you're on immune suppression. In terms of side effects, I think we're going to go through the common side effects that most patients will experience, but being on immune suppression does not increase your risk of these side effects. And many of these are short-lasting side effects. And the reason to have these side effects is to show you that your body is actually doing something with the vaccine, generating an army of antibodies. So if you ever come in contact with the real virus, your body will be ready to go. So these short-lasting side effects are not concerning at all. They are to be expected. Yeah, and what I did here, our patients can see that I had a little trouble with my red box here, that second column, which is all the vaccines. And the most common side effect is pain at the injection site. You can see fatigue, headache, muscle pain. About 10% of patients will get fever and chills. And I'm just showing you that in the third and fourth column, you can see the Pfizer side effects from dose one to dose two. And if you just look at numerically, it does seem that adverse effects are a bit more common after the second dose. So if you had an easy time with the first dose, you might experience some more symptoms with the second dose. And between Pfizer and Moderna, there's not really a difference in the adverse effect profile. I forgot to call on Lauren, so I'm going to come back to Lauren. So Lauren, there's been a lot in the press about the lower overall effectiveness of the J&J vaccine. We know that the Pfizer and Moderna vaccine are about 95% effective, and the J&J is mid-70s. Do you want to talk about that a little bit? Yeah, thanks, Ray. I can talk about that. So we have to keep in mind a little bit when looking at comparing the two earlier vaccines, the Pfizer and the Moderna versus the newest vaccine, the J&J, that they were developed at different times within the pandemic, and that more recently we've all heard that there have been multiple variants that have made their way to the U.S. and have been around Europe, and the J&J vaccine has actually been tested against these variants and may account for some differences. And also, you know, the vaccines themselves have different mechanisms of action. The first two are mRNA vaccines, and the second one is a adenovirus vector vaccine. But all in all, all three vaccines are highly effective against severe COVID. They were just developed at different times with a different subset of patients and different knowledge in the pandemic. So, Lauren, one of my patients asked me if the mRNA vaccine can integrate into our DNA. That is another great question. So, it is a little confusing. This is, you know, a technology that has actually been looked at prior to the even discovery of COVID-19, because we've had other experiences with SARS virus in the past, which is a similar virus. And this particular vaccine utilizes mRNA, which does go into the cells in your body, but it does not go into the DNA. The vaccine immediately starts producing the proteins needed to fight the virus. So, there's no incorporation into genetic material or DNA at all. Great. Ray, I really like the analogy Dr. Patio has taught me. If Sima will share that. Sure. I like to think of it like a recipe. The mRNA vaccine is a recipe that your body is using to make these proteins that then go through the process of generating antibodies. So, it's a recipe. It's not something that's going to take over your kitchen. I have not heard that. I'm going to definitely steal that and use that in practice for sure. Okay. I'm going to give this to Uni. Uni, can I receive the vaccine if I've had prior allergic reactions? And I think I have a few slides that we can go through. Yes. That's a great question. So, we definitely want to take extra precaution if you have an allergy history, a severe allergy history, anaphylactic history. And as you can see on this slide, it's still very uncommon to develop anaphylactic reaction. And these patients are generally recommended to speak with their healthcare provider, whether it's their primary care doctor or their gastroenterologist to discuss whether they are at increased risk of these anaphylactic reactions. And in general, everybody who gets these vaccines or monitor for 15 minutes, patients who have had anaphylactic reaction to certain medications or foods are monitored for a longer period of time, about 30 minutes. Yeah. And so I wanted to show this slide. Uni mentioned the monitoring. So we included this. And the rationale for that is a solid one. You can see that most, these are anaphylaxis reports through the vaccine registry for the COVID vaccine. And you can see some details about the patients that had anaphylaxis with the different vaccines. And you can see that the majority of them occur within 15 minutes, which is the recommended wait time after the vaccine. And the majority of these patients had a history of allergies or allergic reactions, although only about a quarter of them had had a history of prior anaphylaxis. And the recommendations, which I didn't know until we started researching this talk, actually, is if you had a history of anaphylaxis, these are the bee sting type reactions with lip and tongue swelling and shortness of breath that you're going to need to go to the emergency room or call 911. Those type of reactions you probably need from a vaccine. You need to consult with your physician before receiving anaphylaxis to any other, for any other cause you should proceed with caution with longer observation. And importantly for our patients listening that may have had reactions to Remicade or other therapies, they do recommend that instead of waiting the 15 minutes, do you wait an entire 30 minutes in observation after you receive the vaccine. So I think that's very, a very sound recommendation and an extra 15 minutes to surf the internet on your phone is not a big deal. So if you have any questions about that, please talk to your provider. Okay, coming back to Dr. George, should I get tested, should I get antibodies tested after I receive the vaccine to determine if I'm immune? So the short answer here is no. You do not need to and should not get antibody testing. As we talked about now, multiple questions, all three vaccines are highly effective. And you saw the numbers for Pfizer and Moderna that only one patient develops COVID after receiving these vaccines. Therefore we know that once you've received your two doses as far as Pfizer and Moderna and one dose, as far as J&J, and then have waited the appropriate time period which ranges from 10 days to 28 days, you are considered immune and it does not require follow-up antibody testing. Yeah, Dr. Wong's made a really good point about this as well. So sometimes when you're doing antibody testing after vaccination, even though the titers may be low, we don't know what happens when you're exposed to the pathogen, in this case COVID, whether your body would then mount a vigorous immune response to it and protect you. So we just don't know that. We are going to be part at University of Maryland, but our pediatric and adult group is going to be part of a multi-center study called Prevent COVID. So it's named Well, where we're going to try to get serologic testing in our patients before they get vaccinated and then at various time points afterwards to try to answer this question. So if you're a patient in our practice or if you will be a patient in our practice, you can definitely inquire about that and we can get you enrolled in that study and hopefully we'll understand a bit more about what those antibodies mean. Okay, I've been ignoring Dr. Plotil. So SEMA, will the vaccine worsen microns or colitis? So I think all our patients can feel reassured that this vaccine physiologically doesn't have mechanisms that we would be concerned would worsen your Crohn's and colitis. In addition, the secure IBD registry mainly looked at the question about how COVID outcomes were in patients with IBD, but as Dr. Cross was mentioning, the upcoming registry is going to look at that definitively. But as of now, we really have no evidence and we have no concern given how these vaccines work that that would happen to our patients. Yeah, I agree. And unfortunately amongst the four of us, we've had dozens of patients infected, unfortunately. And we certainly haven't gotten that perception that our patients have worsened because of the infection. And on the fortunate side, we've also had dozens of people vaccinated, if not more than that already. And so far, we have not seen a signal. I'm glad you brought up the secure registry because one of the things that we forgot to talk about was the risk factors in the secure registry for the patients with Crohn's and colitis were exactly what you see in a general population. So increasing age, starting at about age 50 and increasing by every 10 years. And then the number of comorbid medical conditions, basically starting at one and going up from there was associated with worse outcomes, mirroring exactly what we see in patients without IBD. Okay, this is going to go to Dr. George. Do I still need to wear a mask and practice social distancing after I'm vaccinated? Thanks, Ray. So this question has actually changed as of this week. The most important answer is when you're in public, around large crowds or around mostly unvaccinated people, you should still wear a mask and you should practice social distancing to protect yourself and others. However, now the restrictions have been loosened a little bit by the CDC as of earlier this week. They've said that if you are in a small group of six or less people with your household or one other household of vaccinated people, you can be without a mask. But again, in a large crowd in public or with unvaccinated people, you still need to practice social distancing and mask wearing. Agreed. All right. And last question before we open it up. So this is going to go back to Dr. Pateel. How do I get the vaccine? How do I register? So I looked up today as many different ways as I could find to register for the vaccine. And I guess the good news and the bad news is there are a lot of ways. There really isn't one centralized way, but we have a couple of links here that we think are reliable and really helpful in looking for possibilities. So the Maryland Department of Health I'll talk about first because in addition to registering for the vaccine, they have very clear statements about what phase Maryland is in in terms of eligibility. So that's always a good reference to look at. But there is a link on that website that will take you through a registration process. And the true allotment depends on your county. And so there's some nuances there in terms of availability of vaccine. University of Maryland is also undertaking a large vaccination effort and they have are helping helped open and staff some mass vaccination sites in Baltimore. So those are available. There are additional mass vaccination sites throughout the state that patients can look for including six flags, which you may have heard of. And then finally, pharmacies. So the usual pharmacies you go to are starting to get increasing supplies of vaccine. So looking for appointments through those common pharmacies is also a possibility. You know, like Ray mentioned earlier, we're really seeing a very promising trajectory in vaccination sort of speed of vaccination and availability. And our hope is that as we continue up that trajectory, we're really going to start seeing things open up. We're truly hoping for that statement to be true that by the end of May, every adult American will be able to get vaccinated. So hopefully we continue to head as fast as possible in that direction. Thanks, Seema. And hopefully you can, the patients can see this. I'm going to go through the different links that Seema found today to help. One of the very common questions that we get is, is there something that we can do as providers to expedite them and move patients up? And the answer is no. We really don't have any ability to move people up on a list to help you get vaccinated any sooner. We have no say in who gets it and when they get it. I showed you data that you're not at increased risk because of your Crohn's and Colitis and your meds generally don't increase your risk. However, if you're checking a box for chronic illness, you do have a chronic illness and you are on an immune suppressant and biologic. So if that helps you, this is the one time in your life that you can use your chronic illness to your advantage to get the vaccine a little sooner than, than please do it. The other question I'm going to ask my colleagues is, I often get asked if I can provide a letter proving that they have a chronic disease or they're on an immune suppressant or biologic. And I don't, I can't recall a patient ever coming to me and saying, they got turned away because they didn't have documentation. So I don't think that's needed, but I want to open up here for my colleagues to see if they've had a different experience. I agree with you. Sorry. I don't think there are a strict about it at these vaccination center. And they're so efficient at getting people in and out that patients have not been asked to show a letter. However, I have been providing these letters for some of my patients just in case if they needed documentation. I will say I think some of the confusion might come from the fact that different states have different requirements. And so I have heard of other states where that kind of note is required to sort of prove that you have the chronic illness you're reporting that you do, but Maryland is not one of those states. All right, great. I'm going to keep this slide up for a bit and stop sharing my screen. So as Aaron said, these are going to be posted on the website. So if you miss something, if you want to go back and look at it again, if you have loved ones, friends that want to view it, they'll be able to view it. If you're not a patient of our program and you're interested in becoming a patient in our program, Aaron's listed the website and our main office number to contact us. We're happy to see you and take care of you. I'm now going to open up to my colleagues and I'm going to open it up to Aaron for any questions from the audience. Thank you, Dr. Cross. Please take this moment right now to fill out all of your questions. And the first one I have is from Matt who lives in Hagerstown. Do you have, do you offer any telemedicine appointments? Yeah, so that's interesting. So I've been doing telehealth since 2015 for a small group of patients with a, with Care First Blue Cross Blue Shield insurance because that, that insurance will pay for telehealth. Once the pandemic hit, we were fortunate that I had been doing that because our office really within a week, all four of our providers were offering patients telehealth. So we've been almost exclusively 90% virtual in our group. And we've been able to maintain really good access with our patients. In fact, we're seeing more patients because it's just a little easier to see people virtually. Patient satisfaction has been very good. It's allowed us to maintain the monitoring that we need. And so I think it's been very positive and I think it's here to stay. I don't think that, and we could talk about, if you want, we could talk about some of the reasons why this was difficult before the pandemic. But I think patients that are listening here and throughout the country are just not going to allow payers and state licensing boards and other people to say that they can't use telemedicine anymore. Because I think it's incredibly convenient. Patients really like it. Now, I do think that we need to go back to the office. And we're starting to do that this month where we're striving for about 50% of our visits to be back in the office. We do feel it's safe to come in for office visits. There are certain advantages to office visits. One, I think it's good for a provider to put hands on a patient's belly and listen to the heart and lungs and getting a good set of vital signs. Periodically, I think that's important. Some of the questionnaires that we routinely do for quality of life and depression and nutrition questions that we ask are harder to do electronically than they are in person. There's other aspects. We have this really awesome integrated team that includes a behavioral health specialist, a dietitian. And we have pointer care vaccinations, meaning we can give you vaccines at the clinic visit. You can get your blood work done at the lab at that same visit. So we can really do a bunch of things within an hour, hour and a half. We can check a lot of the boxes. And you can't really do that virtually. It's much more difficult. And the last thing that I would say is I think our entire group feels that although we have seen new patients for the first time virtually, something's lost in seeing a new patient when you don't meet in person first. And I don't know that we're ever going to go back to shaking hands, but elbow bumping, fist bumping, whatever it is. I think there is value for that first visit to be involved in the integrated care, but also to develop a personal connection with your provider. So we're going to really try as much as possible to see new patients in the office first and then transition to tell how. So what I imagine will happen is you're going to have an in person visit and then your next visit will be virtual and it'll alternate. Seema, uni, Lauren, do you want to add anything to my long winded answer about telemedicine? No, I agree. Right. It does add extra value being able to do a physical exam than having a patient lift up his shirt in front of a camera to show me something. But with that said, we accommodate a lot of patients that live far. So if there are individual reasons you cannot travel or haven't been vaccinated, we'll work with you to accommodate your needs. Great. Thank you. The next question is from Jennifer. She wants to know if getting the shot will put you into a flare. Seema, you want to take that one? Sure. Yeah. So thankfully we have not seen this in our patients and mechanistically the vaccine should not work to precipitate a flare. So we feel pretty safe that our patients can get the vaccine without fearing worsening disease. Yeah, I agree. And there's not any vaccines out there that have shown an association with relapsing of auto immune diseases. One of the newer vaccines is the new shingles vaccine for any of the patients that have had that. I'm actually eligible for that now. It can be a really nasty vaccine as far as flu-like symptoms after you get it. And our patients have been getting that routinely. And we haven't seen any worsening of their underlying Crohn's and colitis after that vaccine. And I don't think we're going to see it with this either. And the one other thing I tell patients is that, you know what, we're good enough to be able to take care of a relapse, but, you know, I can't manage you on a ventilator with severe COVID infection. So even if it was a worry, I'll take my chances with that as opposed to severe COVID infection. But I don't think it's going to be an issue. I agree completely with Seema. Thank you. The next one is from Erica. That says, we must keep up with vaccines of other types. Should these be spaced out in certain lengths? IE pneumonia, flu, should they be spaced out in different times? Yeah. So my understanding and I'll have my colleagues help me hear the recommendation from the CDC is that you don't receive another vaccine within two weeks of the COVID vaccine. And I would assume that they mean after you they mean after the second COVID vaccine, right? Because you're gonna, for Pfizer and Moderna within a week, you're gonna get another dose. I think that's more theoretical. I don't think it really matters, but that's what the recommendations are. So for flu, pneumonia, tetanus, diphtheria, pertussis, hepatitis A and B, the vaccines or routinely giving HPV vaccine, you wanna space it from the COVID vaccine. Seema, uni, Lauren, did I answer that correctly? I agree. I mean, I think in these times when we are really watching eligibility and demand is outweighing supply, if you can get your COVID vaccine, get that, we will work around it for your other vaccinations. So we definitely do wanna protect you from all of the diseases that are vaccine preventable, but right now we are definitely placing priority on the COVID vaccine just for sheer, difficult supply. Great, thank you. The next question is from Erin. Are any COVID vaccines considered live vaccines to be avoided for folks on remicade? So I'm gonna give that to Lauren, but I'm gonna modify it. So for any of the currently approved drugs live or attenuated live viruses, Lauren? That's a great question. So all three COVID vaccines, none of them are considered live vaccines as far as live COVID or coronavirus particles. The, as we discussed before in the talk, the Pfizer and Moderna vaccines are this a totally different technology with these mRNA particles that contain a protein on the COVID. The coronavirus itself, what does not contain the virus or live virus. The J&J vaccine is a little different and more like our traditional vaccines where it uses a virus that does not cause disease in humans and is not the coronavirus and just again incorporates this protein into it to allow our body to respond, but it is not infective to humans and it does not contain the actual coronavirus that we are concerned about. Completely. One of the good things, yeah, to remember about it is that that adenovirus, it can't even replicate. They have removed its ability to replicate. So that's really, I think the key for people to feel confident that it's not gonna give you adenovirus either. And to take it a step further, none of the vaccines that are currently on our schedule are regularly recommended scheduled vaccines are live. The old shingles vaccine was a live virus and we don't give that anymore. We give the newer vaccine, which is safe. Adults aren't getting varicella vaccine. So that is a live virus. There's some other exceptions. When we were worried about measles and that seems to be long ago, we were worried about measles, but the MMR vaccine is live. So if you're getting any sort of unusual vaccines, that you're not quite sure about safety, talk to your provider. There are vaccination clinics actually that can help address some of these things. Once we can start traveling again, if you're gonna be going to some developing countries and there's different vaccines recommended, you can work with your provider to figure out what it's safe. But the routine things that we're recommending any patient on a biological immune suppressant can get them. Great, thank you. Because of the medications we are on because our immune system is somewhat dysfunctional, will our bodies fight the COVID vaccine? So, Yuni, do you wanna address that? So that's a great question. To date, we have not had evidence that IBD patients or IBD patients on immune suppression do not respond to these vaccines. Similarly, in the rheumatology world, they have not seen any evidence of patients being on immune suppression, having lack of response to the COVID vaccine. So we're we're sure that the vaccines that are available are going to be effective and safe for our patients with autoimmune disease and those that are on immune suppression. Yeah, I agree. And our newer medications that we're using are really very precise. They're not these blanket immune suppressants that wipe out your immune system. They're really targeting very specific aspects of your immune system that is triggering the Crohn's or Colitis. Now, prednisone, that's different. It's much more broad immune suppressive effect. But the drugs that we, the biologics we use are much more specific as a target. And one of my friends who's probably one of the world's leading immunologists in Crohn's and Colitis, we've had this discussion about, well, what if the vaccine's 10 or 15% less effective just in theory because of the medicines we're on? And her answer was, well, it's a whole lot better than 0%, right? And it's still probably likely going to prevent severe COVID. So there's not much you can do about it, get the vaccine and then we're gonna learn over time how long the immunity lasts and what the impact of the meds are. But for now, smile when you can get your vaccine because it'll be a mental relief for sure. Great, thank you. This next question is from Dana. The slide about local and systematic reactions, are those side effects for people with IBD and autoimmune or is that for everybody? That was everybody in the vaccine trials. This one is from Ali. What data has been collected and analyzed so far on how these vaccines affect IBD patients in regards to flare ups and immune response and autoimmune diseases? Sima, do you wanna tackle that? I think this is going to be the big focus of the newer registry that we mentioned before. Those are sort of the two big questions. So you're really targeted kind of what the IBD thought leaders and researchers are thinking our exact question. So this new registry is going to be focused on how do patients with IBD do with a vaccine in terms of effectiveness and also in terms of their own IBD disease outcomes? Yeah, the prevent COVID registry is gonna have the goal is 1,000 patients. And I mentioned that Sima, uni, Lauren and I that we haven't really seen relapses in patients that got the vaccine. But to see small differences in relapse rates will take hundreds, if not 1,000 patients to really be able to answer that. The secure IBD registry that we mentioned also is collecting some information on whether patients have received the vaccine previously. That'll sort of address the question of the vaccine protective somewhat, but this 1,000 patient study should answer the question definitively. Thank you, Dr. Cross. How important is it to adhere to the second dose timeline? Can you get it slightly earlier or later? Lauren, you wanna tackle that? Sure, I will do my best with that. From my knowledge of the vaccine timing, it is fairly important to adhere to the recommendations. I know they have data on exactly at what point your immunity peaks and when it wanes. And I think they do have evidence and reasoning to provide those recommended intervals. I do also think that we are all busy and life is returning somewhat to normal and work is getting busier for people. So if you have an issue come up, if you have something going on, a conflict, I do know that I'm sure you can delay it for a day or two or work with that, but I believe we should stick to the recommendations if possible. Yeah, and they really try to lock you in too. Like you get that first dose in your shoulder. Hey, they really, you're coming back exactly in three weeks and they're pretty tough. I agree. I think if you're a couple of days earlier or later, maybe even a couple of weeks, you're probably okay, but you certainly wouldn't wanna get a dose and then have it lapse two or three months. Then you're really getting in a gray zone or black box where we really don't know. So I think you wanna stay as tight as possible. That brings up a question I forgot to include for any of you who wanna take this. So Jane Doe had COVID infection in January and has the opportunity to get one of the vaccines the first week of April. Should she get it? So the CDC does definitively recommend that even patients who have had prior COVID infection should get vaccinated. I won't get too in the weeds with why, but the thought is that actually the immunity from vaccination may be more robust and longer lasting than immunity from infection is what I understand. So certainly prior history of COVID infection doesn't protect you long-term. It's still, vaccination is still recommended. And some providers have recommended that you wait six to nine months when we think immunity from infection wanes. And the rationale for that is that there's some concern you might have more vigorous side effects from the vaccine. And again, if you know, you're gonna feel punky for a couple of days and you know why you feel bad, for me it's worth it. But some patients may get really afraid then to get the second dose, but I think we need to follow the CDC guidelines which doesn't matter if you had the infection two weeks ago. If you have an opportunity to get the vaccine, one caveat I did forget to mention is if you have had COVID infection and were treated with one of the monoclonal antibodies, there is a recommendation that you do wait, I wanna say 60 days before you get vaccination. And the reason is they feature that the monoclonal antibody can actually sort of prevent a robust response to the vaccine. Yeah, we gobbled it all up, wouldn't it? Great, thank you. COVID includes very few cases of young children under 12. Is there any anecdotal data on risks? Uni, you're our transition specialist. By the way, we're all adult gastroenterologists, so this is a little out of our wheelhouse, but Uni, you wanna try to address that the best you can? If you can't, that's fine, because I don't know the answer to that. I think Uni is having difficulty with her. Her mic, she mentioned that she can't unmute herself. Okay, yeah. I think... I just unmuted Dr. Wong. Thank you. Thank you. So anecdotally from discussion with pediatric GI providers at our institution, I haven't heard of severe complication or even infection rate has been reported as very low, but that's all anecdotal experience. Yeah, I mean, we know that the children under 16 were not part of the vaccine trials. I believe that there's trials that are ongoing with younger kids. We know that mortality and severe complications is really low, but it's not zero. And I think one of the things that makes me worry about my 17-year-old, my 15-year-old is we don't have any idea what the long-term complications, if any, are gonna be of COVID. You hear about this long-haul syndrome where patients have disabling fatigue, brain fog, headaches, loss of appetite that persists for weeks and months, and what other things might we see down the line. So for my kids, I'm trying within reason to try to protect them as much as possible without having them mentally decompensate from being isolated. It's really hard as a parent to try to balance that, but I just don't think we know what some of the long-term effects in the short-term, I think they're probably gonna do fine, but in the long-term, I don't think we know what that infection will translate to. I don't wanna be too doom and gloom, but I just don't think we know. I agree, and as a parent of younger kids, my fears are focused on these rare, but really scary incidences of multi-system inflammatory syndrome caused by COVID that they're seeing some patients that can affect heart function and really require hospitalization and ICU. So I agree with Ray. It's sort of the numbers and statistically that things are less likely to be severe with kids, but you never really stop worrying, I think. Yeah, and when the vaccines become available to children, I think I would definitely find my kids up for it. Great, thank you. I think the adults are suffering a lot from social isolation. I know we as a group would love to be able to see each other in a social setting, but really the kids, they need to get back to normal as soon as possible, because I know this is an adult program, but our kids really seem to be suffering. They need to get back to school. They need to get back to sports. They need to get back to a normal life, and I think it's coming. I think it's coming soon. Great, thank you. We are at time, but we'll take just a few more questions. Is the vaccine safe if you are in the middle of a pretty severe UC flare? That's a really good question. To me, we don't want you flaring, but if we were treating your flare and you had the opportunity to get the vaccine, if you were my patient, I would say get the vaccine. Yeah, I think it's the same answer to if you're well versus if you're in the middle of a flare, I would get the vaccine. Great, thank you. And our last question is, are COVID vaccines gonna have to be re-administered every year like the flu? All right, Seema, you get the final answer. So what's the future hold for the COVID vaccine? Yeah, I think there's obviously gonna say the thing that I've been saying, I feel like on repeat, there are so many unknowns, I think at this point, but I feel like a lot of us have a hunch that that may be where we're headed, that there's not really a likelihood of reaching zero COVID infections, that there may be sort of a simmering kind of situation like flu or a seasonal situation with COVID, just like we see in flu. And so just like H1N1 sort of gotten rolled into things, I think it's not unreasonable to expect that we might be going that way for COVID as well. Great, thank you. That's all the time we have today. Thank you, Dr. Cross and the entire team at the University of Maryland IBD program at the University of Maryland Medical Center. If you have any more questions, you can sign up for an appointment by calling 410-706-3387. Thank you. Thanks everyone for attending. Thank you. Thank you.