IBD Drive Time: Freddy Caldera, MD, on Vaccines for Patients With IBD
Freddy Caldera, DO, returns to talk to IBD Drive Time host Raymond Cross, MD, about the best current recommendations for patients with IBD in the midst of controversy and confusion.
Raymond Cross, MD, is director of the IBD Center at Mercy Medical Center in Baltimore, Maryland, and professor of medicine at the University of Maryland. Freddy Caldera, DO, is DO, PhD, MS, is an associate professor at the University of Wisconsin School of Medicine and Public Health in inflammatory bowel disease (IBD) care and vaccine-preventable diseases.
CLINICAL PRACTICE SUMMARY:
- FDA recommends COVID vaccination for adults ≥65 years and ages 18–64 with high-risk conditions. ACIP endorsed shared clinical decision-making—any adult may receive a COVID-19 vaccine following discussion with a clinician or pharmacist. No new safety concerns or out-of-pocket costs were identified. Both mRNA and recombinant (non-mRNA) options remain available.
- CDC recommends the Shingrix recombinant zoster vaccination for immunosuppressed adults <50 years with IBD on JAK inhibitors, anti-TNFs, or thiopurines, regardless of prior varicella infection or antibody titers, which are often unreliable. Clinicians may vaccinate once patients are stable and off prednisone.
- Pneumococcal vaccines PCB 20 or PCB 21 are now single-dose, lifetime vaccines for unvaccinated adults. Patients who received PCB 13 and two doses of PCB 23 are also considered complete but if the patient received only 13, or did not receive two doses of 23, the patient should receive PCB 20 or 21.
- In pregnancy, updated GRADE data support rotavirus vaccination for biologic-exposed infants and RSV + Tdap for mothers.
- Among patients with IBD who were never vaccinated against measles, the safest biologic to use when administering the live measles vaccine would be vedolizumab.
TRANSCRIPT:
Welcome everyone to IBD Drive Time. I'm Raymond Cross from Mercy Medical Center in Baltimore and I'm thrilled to have my friend Freddy Caldera from University of Wisconsin here to talk about vaccines. Freddie, welcome back to IBD Drive time.
Dr Caldera:
No, thanks for having me again. Always glad to have conversations with you, Ray, and I think this is an important one with everything, that's all the mixed messaging and missed things that have been talked about COVID vaccines. I thought it would be a great topic to cover.
Dr Cross:
Yeah, I agree with some of the new leadership changes. I think there's been confusion and even within my state in Maryland and looking at the guidelines from our health department, it was very murky. So who should be getting the COVID vaccine? Let's just start with that.
Dr Caldera:
So the ACIP—the people who recommend vaccines, so that people know—all those 17 members with changes were let go. Typically the COVID vaccine recommendation or flu vaccines happen in June. The reason there's a lot of confusion is this meeting didn't happen until September 19th and at that meeting there was a question of who were they recommend because the FDA had come out and said only 65 and up and 18 to 64 at high-risk conditions. At this meeting there was a lot of discussion whether you need a prescription, should we even do it, not based on new safety data, not based on any new concerns. At the end of the day they still said anyone 65 and up can get a vaccine. It's a shared clinical decision making. So it's not saying you can't get it, you can still get it and for adults it's still everyone 18 to 64 can still get a vaccine as long as they have a discussion with somebody.
And that's a very big term because you could go to the pharmacy and just say, I want to get vaccinated. And that's still a shared clinical decision making. So the ACIP did approve that. Yesterday a lot of people might've heard news, the interim director of the CDC, because the previous CDC director was fired, they rubber stamped that decision, but it took a couple of weeks, which typically those decisions happen right away. So at the end of the day people can still tell their adult patients, they can still get a vaccine, pregnant women can still get a vaccine and these vaccines are covered because they're recommended by ACIP. It's just not a universal recommendation. It used to be.
Dr Cross:
There was a very—everything you said was important, but there was one very important piece there I want to make sure the listeners understand is that there have been no new safety concerns raised about the COVID vaccine or mRNA vaccine specifically that changed this wording. And the other very important point there is that there shouldn't be any out-of-pocket costs for the COVID vaccine with this new change.
Dr Caldera:
Correct. So that means if you work in a big health system and you have COVID vaccines in your clinic, you can give them. You can send people to a pharmacy and they can go show up to Walgreens. No one has to say, I have a preexisting condition. They can just say, hey, I want to get vaccinated. You don't have to send a prescription. And one thing that actually wasn't covered is even if you had a patient that's concerned about mRNA vaccine, there is a non-mRNA COVID-19 vaccine. It's called a recombinant vaccine and we have a lot of those. Our shingles vaccine is that, our Hep B is one of those. So even if you have someone who's like, well I'm not sure, there's still a vaccine that's available to prevent complications and issues with COVID.
Dr Cross:
Thanks for reminding me of that. Now when I'm talking to patients about this every day, and I just want to make sure I'm counseling patients properly about this, my logic is that most of our patients are not currently, with this variant of COVID, are not going to be hospitalized, end up on a ventilator in the ICU or die from COVID—the vast majority of our patients. And Crohn's and colitis and our advanced therapies do not increase the risk of contracting COVID or having severe COVID. But my logic is that why wouldn't you take a safe vaccine to prevent an infection, which if you've had it, can be a pretty nasty cold variant, it can put you out of work, it could put you masked for several days. And my understanding is that the vaccine has also been shown to prevent some complications like Long COVID. So am I telling patients the right thing, Freddy?
Dr Caldera:
I mean when I talk to patients, I tell them it's unlikely that you're going to get hospitalized for COVID if you get the disease and you're not vaccinated. If you're above 65, though, even data from last year showed that older adults were still at risk to get hospitalized from COVID and they comprised 70% of hospitalizations. And these are real hospitalizations because the CDC still has networks called COVIDNet where they review charts because we don't test for COVID anymore in the past. And people would question data of what is the COVID hospitalization. So in older adults that's still a risk factor.
Other things like long COVID are still an issue. And even there's data from the CDC that 1 in 4 older adults above 65 develops a new complication that's known related to COVID, like blood clots, cardiovascular issues, and 1 in 5 in adults 18 to 64. Because we know SARS-Cov-2 can be a little bit of a vascular virus, too. So it's more just, I'm not telling patients go wear a mask, I don't wear a mask, but it's like if you could prevent something, why wouldn't you take it? We've actually done some studies in IBD and found that people after COVID infection were more likely to have herpes zoster and RSV. There are 2 studies that we published on that.
Dr Cross:
I'm going to come back to herpes zoster. I just want to remind the listeners that we are sponsored by the AIBD network and we're available on Spotify and Apple Podcasts. So please subscribe so you can get new episodes as they post. Before we move on, perhaps maybe to zoster, anything else you want to talk about COVID, Freddie?
Dr Caldera:
No, I mean I think it's a very hard time with vaccines right now and it's hard to make through the noise, but at the end of the day, Ray, our patients trust us. So while it might be an uncomfortable conversation at times with people, we got people better, they trust us. So I think it's our role to at least bring it up and just say, Hey, do you have any questions? Nothing has changed. I think most providers still are recommending this, but with the world we live in and very confusing, I think it means a lot if we tell our patients, no, I still think you need to get these things.
Dr Cross:
I agree. And I would add two things. One is let's say for example, we're talking about anti-TNFs or JAK inhibitors and there's estimated to be a 2 to 3% risk a year of a serious infection. And patients, when you're counseling them on the drug, they're very concerned. And I do remind them that we can mitigate risk with thoughtful use of vaccines like influenza vaccine, RSV vaccine, Shingrix, pneumococcal vaccination, COVID vaccination, controlling their disease. So we can bring those rates down further because I don't see serious infection rates of 3% in my practice on anti-TNFs and JAK inhibitors. So that's the one point I was going to make. And the second point is it seems like the COVID vaccines really the sticking point. The other vaccines, sometimes flu, but most of the vaccines, they're more receptive and I just tell them, listen, I'm going to take care of you no matter what you decide to do with vaccines. It's my job to give you the best medical advice and I recommend it and if you don't want to receive it, I'm still going to take good care of you. So I think you want to respect their decision as well as much as you can.
Dr Caldera:
Correct. Exactly. Because at the end of the day, even initially as people trust you more or they go to different, it should be a, let's just talk about this, you can't be very judgmental with people because if not, that's not the right way to treat people anyway.
Dr Cross:
Agreed. So I want to talk a little bit about the shingles vaccine, Shingrix, which is a very effective vaccine. And I want to talk a little bit about younger patients or patients that maybe are a little bit older but don't have a history of varicella infection. And so the CDC recommendations are if you're under 50 and you're immune suppressed due to medical condition or medication that you should receive the Shingrix vaccine. They don't mention asking about illness and varicella vaccination or checking titers. They don't recommend any of that. They just recommend the vaccine. So in your younger patients who have had varicella vaccination or in an older patient who didn't get the vaccine and doesn't recall it or has negative titers, are you just following the CDC recommendations?
Dr Caldera:
No, I mean we know that patients with IBD, even young patients are risk for zoster. Some of Millie's data showed that; her data was mostly of people who've had natural disease, so chicken pox. We know that when you get the chickenpox virus or varicella vaccine, you get this weakened virus. So a 19-year-old now who got the varicella vaccine series, they still have a risk of zoster. It's not zero. We presented some work just showing that there is a signal there. Do they need to get the, do I give them the Shingrix vaccine? Do I recommend that? Yeah, if I have someone on a JAK, a TNF, a thiopurine, those are definitely people I want to get them in sooner rather than later. I don't rely on titers because the titers aren't accurate. Sometimes the tests were developed in the era when natural disease was going around, and natural disease induces higher antibodies compared to a vaccine. So I don't rely on the titers. I'm lucky that we're in Wisconsin and I can just see if someone got vaccinated, but I still end up recommending for all my young patients 19 and up to get the Shingrix vaccine eventually.
Dr Cross:
Yeah, that's what I thought about the titers. And that's why for S1P receptor modulators, I never understood the label saying that you should check titers because they're not accurate and I'm not going to delay starting something to give someone a primary varicella vaccination. It never made sense to me. And the other point that I remember is that some people can have a very mild varicella infection and not even be aware that they had chicken pox and so they are at risk for shingles. So what I'm telling patients is correct. This is validating the Raymond Cross Clinic at Mercy Medical Center. I'm doing everything right so far, per Freddy.
Dr Caldera:
I mean Ray, it's you. You always are.
Dr Cross:
Hopefully my wife is listening to this podcast. That would be amazing. But I don't think she would agree with you. Alright, let's talk a little bit about the other thing about Shingrix is that I learned that when you've had shingles, your immunity is definitely boosted for a period of time, but that immunity from reactivation wanes and I thought 3 years was sort of thought to be about the timeframe where that's probably the sweet spot of getting vaccinated. Do you even think about that at all or you just give them the vaccine regardless of when the shingles occurred?
Dr Caldera:
No, I figured the only reason I wait is if I have someone who's on prednisone and develops shingles, I want to make sure that they're going to have a good vaccine response. But once they've, their lesions crusted over, I'm like, we don't want this to happen again. We want to boost you now because whatever it is, are they on a JAK? Are they sicker? There's a lot of risk factors they can have for developing. So I really don't want to forget about it. And I use the same approach in someone just to vaccinate them. I typically don't vaccinate people when they're malnourished, when they're on prednisone, with the Shingrix vaccine, I tend to wait, we even know most shingles from JAX actually happens it takes quite some time for it to happen. Some can happen.
Dr Cross:
Wait, you give it generally you give it as soon as they're willing to take it?
Dr Caldera:
Yeah.
Dr Cross:
Okay. I think this is a more simple question. There are two new pneumococcal vaccines that are highly effective. PCV 20 and PCV 21. So the easy thing is if you've never had either of those vaccines, you give one or the other and current guidelines are they're good for life.
Dr Caldera:
They're good for life. There's data at 65, we don't have enough data because they're so new. So right now they say, wait five years since your last vaccine, but for now it's right if no one's been vaccinated, see which one is carried either in your health system or your pharmacy has and get one of those because it's super easy. Right? Pneumococcal has always been hard, right? It's like do this and then wait 8 weeks, just get one of them and be done.
Dr Cross:
So what if a patient's only had Prevnar 13, then when do they get 20 or 21?
Dr Caldera:
So then it's so complicated. I have to look it up. It's usually I think a year.
Because basically if you haven't completed the series, which in the past meant 13, 23 and 23, so if you didn't get all those 3, you're eligible for either PCB 20 or PCB 21. And I'm from recall and the listeners will have to look up the new ACG.
Dr Cross:
No, you're right. I have the ACG preventive health guidelines tacked here to my board. So that's definitely right. And then if they've had 13 and 23, my understanding, even if they've had 2 doses of 23, is 5 years after the last 23, you're giving them a 20 or 21.
Dr Caldera:
No, if you had, see that's why pneumococcal is so hard. If you had the 13 and 23 and another 23, you're good. You don't need anymore that's defined as completed. You're incomplete if you had 13 only or 23 only.
Dr Cross:
Alright, well I'm glad I asked because I've been, well, I've been giving people extra pneumococcal vaccines, which is not going to hurt them.
Dr Caldera:
Not going to hurt them. We'll probably get, there's actually new pneumococcal vaccines in the pipeline, so we'll be talking about this in a couple of years again.
Dr Cross:
I also want to remind the listeners that the national AIBD meeting will be running from December 8th to December 10th in Orlando. There's also some premeetings on December 7th. So look for those. I will be there. Hope to see you there.
Any new updates on vaccines in pregnancy, Freddy? I think those been fairly stable.
Dr Caldera:
No, I mean obviously we've had the GRADE updates led by UMA and Millie that's been published in 5 subsequent journals—I think it's 5—that give us a lot of good information. They tell us that we don't have to hold rotavirus, right? You can give a rotavirus vaccine to an infant who was exposed to a biologic, which might not be that big of a deal. But I think in the current era is then sending the wrong message, right? It's not sending the wrong message about what your kid can get, what they can't get. So I think that was a big update as far as concerned of getting a live vaccine. They also talked about mothers who are breastfeeding on a biologic. Their infants can still get a live vaccine. Obviously we don't have as much data on JAKs and S1Ps, obviously that's something we're seeing when pregnancy at all. So they still recommended holding a period before getting a live vaccine for those because we just don't have safety. They still talked about no BCG, but BCG is really not an issue.
Dr Cross:
And we don't even recommend S1PS and JAX for women or reporting any. So that will be less relevant. And the RSV vaccine during pregnancy, that's been out for a while, correct? That's not a new recommendation.
Dr Caldera:
That's and pertussis are out and I remind my patients and that's like, hey, that should protect your infant and that's super helpful. You should be getting it. And RSV is a big deal with infants.
Dr Cross:
So last thing before I ask you a fun question, let's talk about measles-mumps-rubella. So we're seeing outbreaks in pockets in these populations that are not vaccinating their children. And we're starting to see these outbreaks and I have some panic patients asking me about doing titers and they want to make sure that they have immunity. So how are you handling these questions from your patients?
Dr Caldera:
No, I mean I think this is an important question and we'll see pockets because I mean with Texas I saw a lot of colleagues were questioning what to do. So data from the CDC tells us not to check titers because they can be inaccurate. I mean, we also have data that pre-COVID vaccine uptake for MMR vaccine was really high. It was greater than 90. So you can assure that the majority of your patients have been vaccinated. And the CDC says if you have immunization history, that's enough. You don't need to be checking titers because you can run into the dilemma where you have an assay that's not accurate. And now if you're equivocal and not immune, we can't stop therapy. We can't say, let's hold your therapy to vaccinate you. And we have a recent paper coming out in CGH where we walk through what is defined as immunity because if you were born before 1957 when measles was endemic, it wasn't an issue.
We talk about what to do in the theoretical way of saying if you were going to give a live vaccine, we talk about how long you should hold therapy. And we even talked about, let's say, let's say there was a huge outbreak in Madison. I had someone who said, no, my mom never vaccinated me. I think the only biologic I would feel comfortable giving someone a live measles vaccine would be vedolizumab. It's actually in the label. They talk about if the risk outweigh the benefit, you can give a live vaccine. We don't have a ton of data on this, but I think that would be the only medication where I would feel comfortable. I wouldn't feel comfortable giving someone who I know is not immune and is on an anti-TNF, giving them a live measles vaccine.
Dr Cross:
It's interesting, I have a patient who is an accountant and I can't remember the details, but she had some unique offer to be able to go somewhere in Africa for an extended period of time and she wanted to seize this opportunity, but she needed the yellow fever vaccine. And fortunately we had months to think about this and I didn't really have any help from infectious diseases. So what we did is we basically had her miss, we had her hold an infliximab dose, wait 8 weeks, get the vaccine, wait another 8 weeks and then resume the infliximab. And so she basically missed 2 doses and she did fine and she went on her trip and she had no issues. And so I don't know if that's a reasonable strategy. Some patients can't be off drug that long without developing recurrence symptoms. With small molecules, I assume that you could wash them out quicker, but we also don't know how long the immune factor the drug lasts. So just because there's no drug in your system, that doesn't mean your immune system's not impacted. Correct?
Dr Caldera:
Correct. And I think we need more research in this space because not all vaccines are the same. So the old shingles vaccine, that was live, but because that boosted immunity and you already had immunity, we know that people on the TNF could actually get that right, which is very different than someone who's not immune and now gets yellow fever vaccine or measles. So yeah, it gets complicated.
Dr Cross:
Alright, fun question because you're a return guest. It's not a two-parter, but it's an if or I guess. Did you always want to be a doctor? If so, what got you interested in IBD? If you didn't always want to be a doctor, what do you recall being your first career goal that you wanted to accomplish?
Dr Caldera:
So the first part will be a very boring part. I was 6 years old and I knew I wanted to be a doctor, never wanted to do anything else. My parents tried to talk me out of it. They're like, why don't you be a dentist? That's a much better lifestyle. I'm like, I don't want to be a dentist, I want to be a doctor. My dad was a physician in Nicaragua and I remember going with him to the hospital and ever since then, that's what I wanted to be.
Dr Cross:
By the way, for listeners, dentists are doctors by the way.
Dr Caldera: I know, I know.
Dr Cross: I don't want the political backlash on IBD Drive Time, but so what got you interested in IBD then? What was the driver that got you interested in this career?
Dr Caldera:
One patient. So I did my fellowship at University of Kentucky and I was rotating with one of my attendings and there was a young woman who was in college who was sick and I had done her scope with my attending and I saw how miserable she was and we got her better. And I'm like, who wouldn't want to do this? You could switch and change someone's life. So after that one patient I'm like, was my decision made? It was early on in my second year. I'm like, there's nothing more I would want to do.
Dr Cross:
It is interesting, this wasn't the driver for me, but the first patient I had on my medicine rotation at University of Pittsburgh at the VA had ulcerative colitis. And I specifically remember him telling me that his colitis was so bad that he couldn't walk to the street, to the mailbox without feeling the urge to have a bowel movement. And that was the first patient assigned to me as a resident on my medicine rotation.
Dr Caldera:
Wow.
Dr Cross:
Freddy, this has been great. Thanks for the update. I learned a lot. This is really timely for the listeners and I hope to talk to you soon.
Dr Caldera:
No, thanks for having me, Ray.
