IBD Drive Time: Freddy Caldera, DO, on COVID-19 Vaccines and IBD

Dr Freddy Caldera from the University of Wisconsin talks to IBD Drive Time host Dr Raymond Cross from the University of Maryland on advising patients with IBD about vaccines for COVID-19, monkeypox, and pneumonia.

Freddy Caldera, DO, is an associate professor of medicine at the University of Wisconsin in Madison, Wisconsin. Raymond Cross, MD, is a professor of medicine and director of the IBD Program at the University of Maryland School of Medicine in Baltimore, Maryland. 

TRANSCRIPT:

Dr Ray Cross: Welcome everyone to IBD Drive Time. I'm Ray Cross from the University of Maryland, and I'm excited to have our first guest return, Freddy Caldera from the University of Wisconsin, to give us an update on vaccines. Freddy, welcome back to IBD Drive Time.

Dr Freddy Caldera: No, thank you for having me. Always glad to talk about vaccines.

Dr Cross: I know you are. Let's jump right in then. There's been a new announcement on COVID vaccination. Can you give us first an update on what's going on with COVID? What are we seeing as far as rates of infection, serious infections, is the pandemic over?

Dr Caldera: Well, the official announcement was that the pandemic was over. Whether we're not going to see more COVID infections, that's a different story. From the CDC, from August with Omicron, we've had over 94 million cases of COVID, and that's probably an underestimate because there are cases that, Ray, as you know, are probably not being reported because people are getting antigen tested at home and isolating and those aren't going into numbers. But we know that COVID, at least with the current B45, is a little bit different. It's not the same ancestral strain we're having, and with a higher proportion of people vaccinated, it looks like it's a less severe disease, definitely among those who are vaccinated. The data tells us the vaccines work, but even in those vaccinated, the hospitalization rates are a little bit lower and the risk of dying are lower than compared to the original strain.

While many of us have gone back to normal, many people are just tired of wearing a mask, we're still going to see COVID numbers. Whether it's going to become more like the flu, I think it's hard to say. The CDC's announcement is that we'll probably need an annual COVID vaccine. I don't know if we truly know that yet, most likely, but it's become a little bit different. But I guess what I like to tell my patients is we have good data that vaccines are really efficacious at preventing what we care about, which is being hospitalized and the risk of dying.

Dr Cross:
Right. You mentioned that we're clearly not detecting all of the cases because of home kits. What still boggles my mind is over the last several months, I'll have patients message me through the portal or they'll call the office and they have upper respiratory symptoms and they have not tested for COVID. They know what I'm going to say is, "Have you tested for COVID yet?" because although it may not impact what you're personally going to do, clearly you would want to isolate from your friends and families and stay home from work for the allotted amount of time. But it seems like people really are beyond it now, where they're not even thinking that would be a cause of an upper respiratory infection. I'm perplexed by that, but that is just more of a commentary. I agree, I haven't had a patient hospitalized with COVID in a long time, but I am still seeing a fair number of mild infections as outpatients. Regarding treatment for those patients, what's your approach to them? Are you treating them? Are you just letting it run its course? What's your approach been?

Dr Caldera: Thankfully, in IBD we have lots of great people doing great research. We have SECURE, that we know that even before vaccines were widely available, that if you have IBD that doesn't increase your risk for severe disease. We have great studies from PREVENT, the UK, Clarity, CORALE—our study that shows if you are vaccinated, you produce a good vaccine response. If someone just has IBD, I don't view that as a risk factor that I necessarily need to treat you. When you look at the FDA's recommendation for the treatment, the goal of treatment is not to be less symptomatic at home, it's to prevent severe disease. If someone has pulmonary conditions, they have diabetes, they're a smoker, or they're on steroids, that's when I definitely think I'm considering treatment. Even age, it's meant to be 65 plus, even though the official is around 50.

Dr Cross: I've thought about this a little differently, and certainly I'm not an infectious disease person or a vaccinologist, but I felt like shortening duration of the illness is still a pretty good objective of a treatment and if we have pretty widespread access to drug that why wouldn't we give it, so I've actually given it to more patients that aren't really considered high risk and I've been giving Paxlovid. I've learned a little bit that you can see a rebound-type infection from Paxlovid. It seems like maybe you're hinting that that's the wrong approach and maybe you could tell the listeners a little bit about Paxlovid rebound.

Dr Caldera: It's not necessarily the wrong approach. I think my approach initially was when we were mostly using monoclonal because we could say before or even if you're using Euvasheld, if you tell someone, "Hey, you need to get this treatment," but they didn't have access for it, it became this big concern from patients and a lot of the patients who were calling and say, "Hey, I have COVID" unlike the person who didn't test. But those who are concerned, I didn't want to worry them more. If someone really wants treatment, I'm like, "Sure." But if they're like, "Does being on my TNF really put me at high risk?" I tell them, "No." Most centers— I'm sure Maryland has one—at Wisconsin we have a hotline where people get directed right away and they can get treatments.

As far as rebound, that one's a little tough because we don't have, first, a great definition of what it is. Whether you test positive or you just get re-emergence of symptoms. We know from the trials that it was about 1-2% in the clinical trials, but it wasn't significantly different versus the control. But there's definitely been reports from the CDC showing that getting symptoms again after getting treatment is not unlikely to happen. It usually isn't severe symptoms, but I think we just need more definition because we don't have a formal definition of what that is, because in some of the retrospective studies, they've mostly included people who've had symptoms again, just like Biden did.

Dr Cross: Yeah, I guess I think one of the things for listeners is I think it's probably best practice that if you're going to give Paxlovid to your patient, you should at least educate them that there is a 1-2% chance that they could get rebound symptoms, whether it's an infection or just recurrence of symptoms, and it's mild. That's probably the right thing to do, so that they're not surprised by that when it happens. I've had it happen to at least one patient, for what it's worth. I mentioned this at the beginning. The FDA approved a new bivalent booster with protection against the Omicron variant. What do the listeners need to know about this? Who should get it, when should they get it? What's the scoop on this?

Dr Caldera: The way I'm recommending this is we've had our boosters before and that had the original or the ancestral strain.

Dr Cross: Well, we've hopefully had our boosters before.

Dr Caldera: Yeah, hopefully.

Dr Cross: You and I have had our boosters, but maybe not all of our patients have had our boosters.

Dr Caldera: That's correct. But now we have COVID vaccine 2.0, where we have the new variants, and it's like the flu shot now. We don't make a big deal about getting a new flu strain. You can go back all the way to H1N1. After H1N1 caused influenza in the early 2009s, we had a new flu shot and that next year H1N1 was there. This is where we're at with COVID, where there's the COVID vaccine 2.0, where we now have two strains against, it's currently approved for people 12 and up. You can get the Pfizer for 12 to 18 and all adults or you can get a Moderna booster 18 and up.

The big thing about the boosters is we have immune response data showing that the bivalent booster is better than the ancestral booster as far as immune response. We have data that you're going to have the same reactions after a booster dose. We shouldn't be concerned that our patients with IBD are going to get a flare after vaccine. Millie’s done great work showing that, and Gil Melmed also done great work showing that COVID-19 vaccines don't really lead to flares. There are some special situations that I'm telling people to wait. If you've had a recent COVID infection and there's support from the CDC, they say that you should at least wait 3 months prior to getting a booster. That makes sense because if your immune system was primed and now you induce this big vaccine response, you have some protection. You probably don't need to get a booster because you might not be able to mount as good of a vaccine response.

Dr Cross:
I actually thought that I was taught, Freddy, that one of the other concerns with getting a booster on top of an infection is you can have a more vigorous response to the vaccine and more side effects, and that might discourage from someone from getting future boosters. Is that your understanding as well?

Dr Caldera:
Potentially, but more of a concern that booster's not going to induce in a good immune response in a way to the vaccine, and you're wasting that one.

Dr Cross: Gotcha.

Dr Caldera: We actually have a late-breaking abstract at ACG here we're going to show that dose with prior COVID infection 6 months after their third dose were the people with the highest antibodies. It's like you got 4 antigens, so if you got natural infection on top of being vaccinated, you've had an extra exposure to the antigen. The booster schedule was really complicated before, right, because if we're 50 and up you could get up to 2 boosters, and now the CDC has wiped everything clean and they said you can get a booster at least if it's been 2 months since your last booster. When you talk to immunologists and people who've done vaccinology work for quite a while, and there was actually some concern at the CDC meeting of giving someone a booster just 2 months right away after another booster. I'm actually telling people to wait around 3 to 4 months after their last booster dose because it's the same principle. You want to let your immune system be able to mount a good vaccine response. So if someone got a booster in August, I'm not telling them to get a booster again now in October.

Dr Cross: To keep it simple for the listeners, 3 months after infection, 3 months after last booster, you're good to go with the new booster.

Dr Caldera: Correct.

Dr Cross: Perfect. I have a few more questions for you, not about COVID, but about vaccines. Before I do that, I want to remind the listeners that IBD Drive Time is sponsored by AIBD and the Gastroenterology Learning Network. I would remind the listeners is there's still time to register for the in-person national AIBD course in Orlando taking place December 5th to December 7th. Please, register and attend. It will be a fantastic course.

All right. Let's shift gears a little bit, Freddy, and talk about monkeypox. There was a lot of concern, messages from patients and calls. I think the listeners are familiar with it, but can you describe the illness for those that aren't as familiar and what's the group of patients most at risk for this?

Dr Caldera: I similarly got the same concerns. I think many people are worried, here we go again. Monkeypox actually has been around. We've had prior infections in the US, before but they didn't make as much news. We know it's an illness that typically begins with a prodrome where you can get fever, headaches, that has an incubation period that you're not infectious during the incubation period. You're only infectious when you have this flu-like illness, and then you get a very typical rash that is very classic appearing, but it's something where—other than some case reports of death in immunocompromised—it's mostly a self-limiting illness. I mean, definitely I'm sure you've seen pictures of where people get these lesions and they can last for a while, so it's not benign by any means.

Even though when you look at the CDC data, respiratory secretions can be a form of transmission, you really need to have close intimate contact. When you look at CDC data, WHO data, most of the cases have been associated with men who have sex with men. When you look at the CDC, the only people they're really recommending is someone who's had multiple sexual partners within the past 2 weeks in an area where there's monkeypox. When you look at the map of the CDC, that includes most of the United States, but right now other than those or someone who's been exposed to monkeypox, routine vaccination in the general population is not recommended.

Dr Cross: So someone who is newly diagnosed, presumably early on would be a candidate for vaccination, and then those that are really high risk exposures, if I'm understanding that correctly. If that's right, any concerns related to immune suppression? Is there any drugs that patients are on that they can't be on to receive this?

Dr Caldera: If you're going to vaccinate, you can vaccinate at least within 4 days of exposure. The reason to just reassure patients that monkeypox is not going to become COVID because even if you Google it and say it's respiratory, it's really, most of the cases have been seen in close physical contact and it's skin to skin. It's not like you're sitting next to someone else in a train. It's skin to skin, bodily fluid exchange.

There are 2 vaccines. One is ACAM 2000, and the other one is JYNNEOS. They're both live vaccines. ACAM 2000 is really a vaccine to prevent smallpox. JYNNEOS is a vaccine to prevent smallpox and is approved for monkeypox. The difference between the 2 are significant where ACAM 2000 can replicate. That's something you don't want to give to anyone who suppressed. And I'll tell you, I probably wouldn't be excited about taking it either unless I had a true exposure as preventative because it can cause auto-inoculation, so you can give yourself pox by having it, has significant adverse events, it can lead to myocarditis and many other side effects. It's definitely not something that I'm recommending for anyone unless they truly need it.

JYNNEOS on the other hand, it can't replicate and that's the one that's been studied in HIV and found to be safe in patients with HIV. The big problem is the supply is limited. The supply is limited so much that the FDA gave in a UA where they said you can give a fifth of the dose, and by giving it that way you could vaccinate more people. Really, this isn't meant for the majority of patients with IBD, definitely only the ones who would be at high risk. For my patients who are at high risk, I would definitely say, you know, can still practice other preventative measures to prevent bodily fluids. Practicing safe sex, using condoms, all those things can still help prevent, and obviously having a sexual partner with active skin lesions, so they need active skin lesions for transmission. They need to be during that illness period.

Dr Cross: But to clarify, because I'm pretty sure I misspoke about this, it's an intimate partner that's been exposed to somebody with monkeypox within a short period of time, 4 days, or someone that has multiple sexual partners in a short window of time in an area where there's monkeypox, which is basically the entire United States essentially. Did I get it right this time?

Dr Caldera: Yep.

Dr Cross: All right, perfect. All right. This is I think, a much simpler one that the guidelines for pneumococcal vaccination have changed. We were giving 20, and 13, and I think we got pretty comfortable with that and then now it's been turned on its head. What are we using now? What are the guidelines?

Dr Caldera: It might change a little bit at the end of October. The CDC is going to have a meeting, their normal meeting in October, and they even might clarify this a little bit more. But it's really easy in someone who's never been vaccinated against pneumonia. In those patients, there are 2 vaccines we can use now. There's the PCB 20 and the 15. If you get the 20, it's one and done. I actually went to my health system and asked, "I want to get this in our clinic because I don't have to worry about giving one a year later, and then do they need one 5 years after that, and then at age 65.” You're one and done. If your health system's already, if that ship sailed and they're like, "Hey, we are negotiated with and you're going to have 15 in clinic," right now, all you have to do is give the 15 and then the 23 one year later. In October, we'll get more guidance of what to do in those who are previously been vaccinated, because that's a moving target. But I would say for our patients who haven't been vaccinated, ask your clinic manager, can you get the 20 in clinic because it's a one-and-done deal and then you're giving a patient protection.

Dr Cross: The way I'm going to remember this, because I'm not as smart, as 20 is a higher number than 15, so if it's 20, you're done, and if it's 15, you're going to do 23 a year later. That's how I'm going to remember that.

Dr Caldera: That's right.

Dr Cross:
All right. Freddy, this has been wonderful. I've learned a lot like I always do from you. Do you have any last comments before we end?

Dr Caldera: The biggest comment would be is that I think what we learned from the pandemic and as we get all these therapies, I think we all just need to play an active role in recommending these vaccines. If we have questions or concerns, if patients have questions or concerns about what they should be taking, that we bring them up, because COVID has definitely brought the attention of risk for infections. As we get more and more therapies that increase remission, we need to make sure that we're doing everything to potentially prevent complications from either dual therapies or combination of biologics and/or new therapies that might increase the risk of certain vaccine preventable diseases.

Dr Cross: Completely agree. Freddy, it's been great. Thanks again