IBD DriveTime: Francis Farraye, MD, on Vaccines for Patients With IBD

Dr Raymond Cross quizzes Dr Francis Farraye on the latest guidance regarding vaccinations against COVID-19 and RSV in this episode of IBD DriveTime.

Raymond Cross, MD, is a professor of medicine and director of the IBD Program at the University of Maryland School of Medicine in Baltimore. Francis A. Farraye, MD, MS, is the director of the Inflammatory Bowel Disease Center at the Mayo Clinic in Jacksonville, Florida, and a professor of medicine at the Mayo Clinic School of Medicine.

Transcript:

Any views and opinions expressed are those of the authors and/or participants, and do not necessarily reflect the views, policy, or position of the Gastroenterology Learning Network or HMP Global, its employees, and affiliates.

Raymond Cross:

Welcome everyone to IBD Drive Time. I'm Raymond Cross from the University of Maryland School of Medicine and I'm delighted to have my friend Frank Farraye from Mayo Clinic Jacksonville back as a return guest to IBD Drive time. Frank, welcome back to IBD Drive Time.

Frank Farraye:

Thank you so much for having me, Ray.

Raymond Cross:

So Frank, I wanted to have you back on because you're one of the world's experts in health maintenance in IBD and in particular vaccines and there's been some new recommendations regarding COVID vaccination and a new vaccine for RSV. So I want to jump right in on the COVID vaccine. So there is a new recommendation from the CDC recently. What do the listeners need to know about the new COVID vaccine?

Frank Farraye:

Well, Ray, I think the last thing we want to talk about is COVID, but unfortunately COVID is not going away. We are seeing some increasing cases over the last several weeks and I think many of the listeners know that the COVID virus that first came out in 2020 is not the same virus that's circulating now. And so the CDC met in mid-September and recommended that everyone six months and older receive an updated COVID-19 vaccine that targets this omicron strain that's the most common variant we're seeing. I just want to reinforce that we know that vaccination remains the best way to prevent COVID-19 related hospitalization and death. And there's also information suggesting that if you get the vaccine and get COVID, you're less likely to get Long COVID. Now, I know there's a lot of concern in some parts of the country about the mRNA vaccines, the classic Pfizer and Moderna vaccine, and we're just awaiting the FDA to give emergency use authorization to a different vaccine called the Novavax vaccine.

That's been around already and it's a protein subunit vaccine that targets the spike protein of COVID-19. It's the same technology that we use for hepatitis B vaccination. So for those individuals that are concerned about mRNA vaccines, although the overwhelming data is that they're quite safe and effective, that would be something to be on the lookout for. And again, I want to remind the listeners about a study in which I participated and you were the senior author, Ray, it was published in the Red Journal, demonstrating that the timing of vaccination does not need to be adjusted based on infusions or injections. So if your patient is getting infliximab, vedolizumab, whatever they're getting and they want to get their vaccine, they should get it. It's better to get it under your belt than defer to try to time it relative to infusions or injections.

Raymond Cross:

I didn't know about the Long COVID with vaccine or perhaps I forgot that, so that's really another important message I think for patients who have some vaccine hesitancy. And Frank, when I've looked at the data looking at, we know that these vaccines can cause significant local reactions and even systemic reactions, although they typically are very mild. And just to clarify, what I've seen is with subsequent doses, there's no evidence that adverse effects directly related to the vaccine increase with subsequent doses. Is that correct?

Frank Farraye:

That's correct. And in general it's hard to predict why one person might feel worse after the first injection or the second. For example, for the Shingrix vaccine, it's impossible to predict. Someone may feel lousy after the first and do better after the second or vice versa. So the bottom line is there's no reason to believe that the adverse risk profile will be any different for the new COVID vaccine that is now actually available. If you listen to the New York Times or listen to the radio, you know there've been some issues with rollout of the vaccine, but I think that'll all be sorted out in the very near future.

Raymond Cross:

And as you said in the beginning of this podcast, there are increasing cases as clinicians, our patients are letting us know that they have a recent COVID infection and it's always a challenge when someone's had a recent infection regarding the timing of the vaccine dose. So I've heard people say 90 days because your natural immunity spikes and you don't want to waste the vaccine, so you want to get a good boost of antibodies. What do you tell your patients, Frank? I don't think there's any firm guidelines on this.

Frank Farraye:

I think you're right, Ray. The first thing to know is that it's still recommended that individuals who had a COVID infection receive the vaccine and this kind of hybrid immunity seems to lead to longer protection. So the CDC recommendations are nebulous, stating that you can consider delaying your vaccine by three months, but you can actually receive it as early as one month after infection. So for someone with inflammatory bowel disease who just recovered from COVID, is not on immunomodulators, not immunosuppressed, I'm going to probably wait three months. But if I have a highly suppressed immunocompromised patient, I'm probably going to give it between one and two months, but that's my personal opinion. We don't have any firm recommendations other than the ones on the CDC website stating that you can consider delaying the vaccination for three months.

Raymond Cross:

Yeah, that nuance is really important I think because I think it's fairly clear now that patients who are on an anti-TNF, they still develop antibody responses but they're not as vigorous and they perhaps don't last as long. So that might be a good example of someone you don't wait the full 90 days, I completely agree.

Frank Farraye:

I would just want to echo one thing though. The antibody responses may not last as long, but actually work that we've done with Freddy Caldera shows that T-cell responses may actually be higher in anti-TNF treated patients. So it's not all antibodies, there's also the T-cell response that may play a role. But the bottom line is if you have a highly immunocompromised patient, I'm going to probably give their vaccine between one and two months. If someone doesn't fit into that high risk group, I'll probably wait three months.

Raymond Cross:

I think that's perhaps then why we don't see higher rates of COVID infection in anti-TNF treated patients compared to other therapies. So it may be that T-cell immunity is protecting them when the other antibodies, when the antibodies fall off. I don't know if this is right when I'm doing, but when my patients message me and they tell me they have recently acquired an infection, I'm pretty liberal in my prescribing of Paxlovid. The logic being that we don't really have limited amounts of the Paxlovid, and even if I'm shortening the illness by a day or two, to me that seems like something reasonable. Am I overprescribing Paxlovid, Frank, or is that a reasonable strategy? How do you do it?

Frank Farraye:

So patients with risk factors should be treated either with Paxlovid or remdesivir. Again, as you pointed out earlier, I kind of live and breathe vaccination, and so earlier this year we published a paper in CGH and we looked at rates of hospitalization and death actually in patients with IBD who received Paxlovid versus a group that did not. And what we basically showed that the risk of hospitalization in IBD patients treated with Paxlovid was 1.8%, but it was 5% in the control group who did not receive Paxlovid. And we did the propensity score matching and Paxlovid reduced the risk of hospitalization by 65%.

So in another study that was done with the VA, again, I mentioned earlier that vaccination lowers the risk of Long COVID, in a VA study, it showed that Paxlovid also lowered the risk of Long COVID. So I think there are a lot of reasons to do that. Now you may be put off by the drug-drug interactions, but typical thing would be a 70-year-old on a statin. Well, you can just hold the statin and begin the Paxlovid, but if there are absolute contraindications, you'd have to use the Remdesivir, which is the IV infusion given once a day for three days. So I use lots of Paxlovid in my patients with IBD.

Raymond Cross:

Well, that's, yeah, I think 3% absolute reduction in hospitalization is pretty important, so I think we're doing the right thing. So this may be controversial, but I've thought about this a lot in thinking about testing for COVID. Do you think we need to have a more common sense approach with this? For example, if you're sick, stay home regardless of what the illness is until you feel better. And then if it's a respiratory illness, regardless of the cause, wear a mask for five days at work and then be done. Do you think that's what we need to do or does this test strategy still make sense?

Frank Farraye:

Nothing like an easy one from you, Ray. I believe that if you're exposed to someone who has COVID, and this is not walking in the hallway, this is in a classroom or wherever and you've been exposed for 15+ minutes, I think you should be tested just so that you kind of know. And the reason is not for yourself, potentially, but for us as physicians, we're in front of immunocompromised patients all the time. In the old days it said that you had to quarantine yourself if you were exposed. Now you should just isolate yourself if you test positive. And then when you recover, again, you can follow the rules, which is typically five days, and we'll talk about testing when we talk about RSV. But right now if you develop an upper respiratory tract infection and you get a nasal swab, it'll test you for flu, so influenza, RSV, and COVID. So you might approach being sick with the flu with a much shorter period before you go back to work as opposed to COVID. So I would basically say if you're exposed, test yourself. If you're positive, isolate yourself following the rules from the CDC.

Raymond Cross:

And for those that are exposed, and let's say they're exposed today and they test, but they have something they want to do, they want to go to the indoor Billy Joel concert. I'm just going to use an example. What are you telling them? If you tested negative, we know it's not 100%. Should you still go about your life or should you warn the people you're going to be around that you've had an exposure? What's a common sense approach to that?

Frank Farraye:

Well, I got to tell you, that's a tough one. I mean there's how you feel and kind of the more societal issue of exposing people. I mean, if I would be pretty upset if the person sitting next to me on the plane knew that they were positive for COVID and got on a plane. So I think, and going to a Billy Joel concert would be a lot of fun and I think there'd be a lot of yelling and screaming and it's unlikely that you keep your mask on. So I think it's a personal decision. There's your own personal health and there's the health of people all around you, but an asymptomatic COVID positive patient probably should not be going to the Billy Joel concert.

Raymond Cross:

Oh, I'm sorry, I want to clarify. You've been exposed, but you did a test and you're negative, but you had an exposure, a close contact.

Frank Farraye:

Okay, I gotcha. Well, you are right that the testing, the sensitivity can be low. I think if you did two tests 24 hours apart, I'd be comfortable without an issue. If there's any concern and you're just going out to dinner or going out to something, I'd wear a mask as much as you could. But again, it's a tough one.

Raymond Cross:

Yeah, and I think full disclosure is really important. So if we're going to have dinner with another couple and I had an exposure yesterday, it's just tell them that, hey, I had an exposure yesterday. Do you still want to go to dinner or do you want to just reschedule for next week? I think that's always the right thing to do. So I just want to remind the listeners that IBD Drive Time is sponsored by AIBD and the Gastroenterology Learning Network. And speaking of AIBD, my most fun course of the year, the national course in Orlando, will be held 12/14 to 12/16. Plenty of time to register and make arrangements to attend that wonderful course. So, Frank, a couple more questions. Let's shift to the new RSV vaccine. What do the listeners need to know about this vaccine?

Frank Farraye:

It's an RNA virus. It's a common infection that leads to pretty significant morbidity and mortality and you know about the individuals that are at highest risk, they're infants, older adults, and immunocompromised patients. In anticipation of this talk with you, I did kind of go to the CDC website to get some data on this, and apparently about 1.4 million outpatient visits, 120,000 emergency room visits, 160,000 hospitalizations, and perhaps 20,000 deaths related to RSV in the United States. Not surprisingly, hospitalizations predominantly occur in patients with comorbidities such as COPD, diabetes, cardiovascular disease, and there's data that suggests that the risk of RSV in adults over the age of 65 with risk factors could be as high as 10% with mortality rates of 5%. So they're similar to influenza.

Patients who are immunocompromised transplant patients, they can be extraordinarily high risk of requiring hospitalization. As I mentioned before, if you have cold symptoms and it's October, the commercial assay, the swab, you'll be tested for COVID, influenza, and RSV. The RSV season is beginning now. If you look at what happened last year, it peaked in October into November. And you can look on the CDC website just like you can look for COVID cases and we're starting to see an increase in cases in the southeast United States. It's hard to tell the difference between RSV and COVID and influenza, so I think if you were exposed, so if you have symptoms and you want to know, I think having this testing would be the way to sort out which of the three you have. And we are concerned about dual infections. You can see dual infections of RSV and COVID, RSV and influenza, influenza and COVID.

Raymond Cross:

And just to remind me and remind the listeners, this is for all adults that are 60 years of age or older are eligible for this. And then is that true or do they have to have comorbid conditions as well?

Frank Farraye:

So what's recommended is that it would be a shared decision making to decide if you want to get the vaccine. So a 65-year-old who's running the marathon, playing tennis every day is different than the person who's got a creatinine of two and was a former smoker. So we'll talk about what I do for my IBD patients, but I think that I'm recommending the vaccine for those individuals who have risk factors above the age of 60. So not everyone I'm going to recommend the vaccine to.

Raymond Cross:

And so that's a nice segue to the IBD patients. I think you're publishing something related to RSV in that our patients have worse outcomes with RSV infection. So what are you doing with your older IBD patients, but also your younger IBD patients that are on maybe a more systemic immune suppressant like an anti-TNF or a JAK inhibitor?

Frank Farraye:

So we already know that our patients are at increased risk for influenza, pneumococcal pneumonia, and zoster, and that can be independent of their disease immunomodulating therapy. In other words, having IBD, having Crohn's disease increases your risk for pneumococcal pneumonia. And so our present IBD fellow, Aakash Desai, and with my collaborators, Freddy Caldera and others from University of Wisconsin, what we did was we looked at the TriNetX data set. It's a data set that has over 70 million Americans in it. And we looked at the rates of RSV infection in patients with IBD. So we had 200,000 patients with IBD, 4 million controls, and we demonstrated that the risk of RSV was increased in patients with IBD. The odds ratio was 2.24. If they were on immunomodulators, it was 3.06. Anti-TNFs was 1.66. And then if you just looked at hospitalizations, it was increased by 1.36. So we now have evidence that there is an increased risk in patients with IBD. That has been submitted for publication and we're doing a revision right now.

So we mentioned earlier that, again, the FDA approved and the ACIP recommended RSV vaccination for those above the age of 60 who have risk factors for adverse outcomes. We went over the risk factors, diabetes, heart disease, COPD, and we now have two vaccines. One comes from Pfizer, one comes from GlaxoSmithKline. These are non-live vaccines, so again, all our patients, whether immunocompromised or not, would be eligible. A single dose appears to cover us for two years, so it'll be a single dose for two seasons. And in the clinical trials, you reduce the risk of getting RSV by about 75%. And again, similar to COVID, you reduce the risk of hospitalization and severe disease by about 90%. The listeners should know that you can give RSV and influenza together, you can give influenza and COVID together, boosters vaccines, but there's no data yet for COVID and RSV, and so it is not recommended to administer those together. So to summarize, I'm not recommending this to every single patient above the age of 60. I'm certainly recommending it for my immunocompromised patients and those individuals who have the risk factors that I just mentioned.

Raymond Cross:

So 60 years and older with comorbid conditions regardless of IBD, and then IBD, if they're on an immunosuppressant or anti-TNF, you're recommending it if they're 60 and over?

Frank Farraye:

Or JAK or basically, obviously we all know that some drugs place our patients at significantly higher risk than others for infections, so that's the group I would target. I mean, I think a 60-year-old healthy person on vedolizumab, ustekinumab, or risankizumab, you might approach differently assuming they didn't have heart disease or the other risk factors. This is not like influenza where every single person should get influenza. It's a new vaccine, safety looks good, but I think not surprisingly, our patients are at increased risk and we should be offering this vaccine.

Raymond Cross:

Wonderful. And now for a fun question. So Frank, tell listeners about your most recent fishing experience.

Frank Farraye:

There are so many to talk about, Ray. I've been trying to perfect my salt water fly-fishing technique, and I spent a fair amount of time on holiday up in Massachusetts and Rhode Island. And as you know, you were unable to visit us during COVID when you presented at our Gut Club, but I'm only about a mile away from the ocean. So I get to go to the ocean whenever I want. And finally I found a couple of ponds in my development and now I'm trying to perfect my fresh water fly-fishing skills. And I'm going fishing this weekend.

Raymond Cross:

For the listeners, Frank took me fishing for steelhead in Pennsylvania and it was my first time fly-fishing and I actually got one of these trophy fish. I hooked one, and of course I did it incorrectly and lost the fish. And the look on Frank's face of disappointment was awful. But he tried for the rest of the day to get me to hook another one and it didn't work. Frank, this has been wonderful. Thanks for doing this. I learned a lot, I'm sure the listeners learned a lot too. Thanks again. Hope to have you back soon.

Frank Farraye:

Thanks again, Ray.

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