Are COVID-19 Vaccines Safe for Patients With IBD?

Marla Dubinsky, MD, and Asher Kornbluth, MD, review the latest information on vaccines for COVID-19, their safety for patients with inflammatory bowel disease (IBD), recommendations from the International Organization of IBD, and the questions and concerns of their patients with IBD.

 

Marla Dubinsky, MD, is codirector of the Susan and Leonard Feinstein IBD Center at the Icahn School of Medicine at Mount Sinai in New York City.

Dubinsky

Asher Kornbluth, MD, is a clinical professor of medicine and gastroenterologist at the Icahn School of Medicine at Mount Sinai.

Kornbluth

 

 

 

 

 

 

 

 

 

 

TRANSCRIPT:

Hello, I'm Dr. Marla Dubinsky from the Icahn School of Medicine. I'm really pleased to be here, along with my colleague, Dr. Asher Kornbluth, also at the Icahn School of Medicine. We wanted to bring you an update on the status of COVID vaccine for patients with inflammatory bowel disease.

Asher, I'm going to get right into the meat of the matter. As you could appreciate, once there was some guidance that was broadened to include patients, not just based on age or above the age of 75, but patients age 16 to 64 who have an underlying, what is considered to be, a high‑risk condition, including pregnancy, which I do want to come back to.

One of the guidance was focused on patients who are on any kind of immunosuppressive medications, or felt to have an immunocompromised state. As you can imagine, that did open up a lot of questions for our patients. I wanted to know how you've managed things so far to date, and how you've approached these questions from our patients.

Dr. Kornbluth:  I can tell you by the time we finish this 15‑minute, or so, webinar, things might have changed in our state, New York, next door New Jersey. From this morning, when I started doing procedures, my 8 AM patient told me one thing, and my 1 PM patient told me another thing about immunosuppression in New York.

This is very fluid. This will change very quickly and it will be different from wherever you are watching it in this country. Patients know about this, so you need to know the questions patients will ask. Every patient I scoped today, every IBD patient, said, "Where am I with my immunosuppression?" As Marla said, we've gone through the early phases, 1A, healthcare workers, nursing home.

1B, which is where the problem is, going from 1B to 1C, and they're transitioning it on a daily basis, hourly basis. 1B used to be 75 and over, or top‑tier essential workers, teachers, first responders, transportation, mass transit, etc. Over the age of 65 and chronic conditions that increase the likelihood of a bad outcome, not every chronic condition, including they don't mention IBD on that CDC page.

At the end of this webinar, we'll post the links, so you can see exactly what they did list. Even the CDC are revising these on a very frequent basis. Our patients with IBD, we had been telling them, "Yes, you have a chronic condition, but it's not what the CDC is listing." Again, remember the CDC guidance is just that, guidance.

Even in their own guidance they say, "This is for your state to use as they think is appropriate", based upon their own demographics, based upon vaccine availability. That was where we were stuck. We were hoping our patients were over the age of 18, 18 to 64, can get it and not have to wait until all of the prior patients in 1B were done.

1C is healthy, 65 and above. Anyone over the age of 16 with Pfizer, or 18 with Moderna, with a chronic condition that the CDC says increases the risk, and this is where we had good news for our patients, patients who are on drugs that, to use these CDC's words, weaken the immune system. Of which, we can say all our drugs do. Not aminosalicylates, but all of our biologics.

They, apparently, are not aware, Marla, perhaps you can mention, that these drugs that we use, ustekinumab, vedolizumab, our anti‑TNFs, as monotherapy, probably reduce the likelihood of bad outcomes. We're not calling up the CDC and saying, "Hey, they're not so bad after all." They are considered drugs that weaken the immune system and would be in "1C."

Now, in many states, as of 24 hours ago, they're elevating 65‑year‑olds to that earlier phase. They haven't necessarily elevated our immunosuppressed patients to that earlier phase. That will change probably by the time you hear this. It might already not apply to you in whatever state you're looking at that.

We need to be apprised of this because, the minute the patients hear that their immunocompromised tier is ready to go, you will get scores and scores of calls. We're probably going to have to document it with a note. Nobody said, "How are you going to walk into your immunization center? How are you going to prove it?"

You need to be aware. The patients, I'm telling them, go online in the morning, go online when you come home from work, because it very well might have changed. Our patients, now everyone's very aware of the importance of drug levels, so we're very cognizant of being, what should we tell our patients?

A, Marla, what's the recommendations, in terms of, should you get it if you are immunosuppressed? Number one, with the current vaccines. Then, perhaps, talk to us about the ones that are probably the next ones, J&J, AstraZeneca, adenovirus vaccines.

One, should we get it? Two, if we're on a biologic, and that's what's really getting us to the top of the list, is there some place in my drug level cycle that is better than other times to get it? What data do we have so far? What information, what guidance?

Dr. Dubinsky:  Also, it would be good to first start with how we've been defining our biologics in terms of immune suppression, immune regulators, immunomodulators. It's confusing. Do we believe that, if we gave a patient a vaccine, that they would mount a response? We do.

We have data from many other vaccines that patients, despite being on biologics, for example, do mount a good response, which makes me think that the terminology of immunocompromised, in a sense, may be a far stretch for our patients. As you noted, we saw maybe a protective effect against COVID with these therapies that we normally said would've altered the immune response.

Even with the virus, they were able to mount an immune response, and if anything, they may have had protection. This is where it gets a little bit tricky. I do believe that patients who are on steroids, high‑dose steroids are in this list of medications that do suppress the immune system.

Just like risk of COVID was increased so far in our IBD patients with steroids, now we're saying that these are the patients that would be eligible to be at a higher risk of getting COVID severity. We're moving them into the category of needing to get the vaccine.

The real question is, do we believe that there's an urgency right now for our patients who have well‑controlled inflammatory bowel disease on biologics, not on corticosteroids, not on immunosuppressives like Imuran or the thiopurines? How do we balance us wanting our patients to get vaccinated without having a lot of data?

I'm going to address what we do know. What we do know is based on past vaccines, obviously, because we haven't had this experience before. When we, as a group, got together through the International Organization of IBD, or the IOIBD, just like we did in March, we felt we needed a global message. We all had a uniform message across the world, given this is a global pandemic.

What are we suggesting or having a consensus on? Just like the CDC, these are recommendations. When you don't have a lot of hard science, you would like to have guidance, you'd like to recommend and have consensus. We did have a consensus that, at the start, IBD patients should be vaccinated. Right off the start, having IBD was not a contraindication for vaccination.

Then we got to a level, do we feel that IBD patients would have the same response as someone who didn't have inflammatory bowel disease? We said we believe they will have a similar response, meaning the same efficacy. We also felt, safety‑wise, will be similar in IBD patients regardless of the medication that they're receiving.

We may have made very general, broad statements about it because we didn't have a lot of data. We were using our knowledge on how IBD patients have responded to previous vaccines. I do want to make the caveat that, patients on steroids, we were not quite sure whether or not they would have as much of a robust response.

I do want to say, Asher, that we didn't feel that there was, specifically, a timing issue. We have a supply and demand issue. If we're going to say, "You know what, wait until your drug concentration, or you're closer to your level, I mean, the time that you're due for your infusion," we may miss that window of opportunity for that patient.

Broadly, we believe, at the moment, again, not saying we have a lot of data, that our patients should be getting it when their priority group is ready to get it, and when there's supply. That's how we approach vaccines and IBD at the moment. I do want to bring up pregnancy for a second because that's probably been one of the more controversial topics.

Yesterday, I had my pregnancy clinic. Of course, everybody wanted to ask about the vaccine. I'm going to give a story of a woman that wanted to know, she wants to get pregnant and she wanted to know whether she should delay conception or delay the vaccine.

The American College of Obstetrics and Gynecologists and the Society of Maternal‑Fetal Medicine came out with a very clear message. The 3 key things they wanted us to know is, one, the risk of COVID itself, the severity of COVID, being infected with the virus outweighed any risk of the vaccine.

Interestingly enough, they also said don't wait for the vaccine to conceive. If you want to conceive, we will give it to you once you are pregnant. They also noted that breastfeeding was safe to do if you got the vaccine. There's a little bit of discussion around whether or not should we wait until after the first trimester, potentially, so that a woman isn't getting a febrile reaction to the vaccine.

We know any type of febrile illness may impact the pregnancy. Also, whether or not the vaccine has any role if you're doing infertility, or if you're planning around conception, should you wait until after conception? There's so much information. Unfortunately, we don't have a lot of data.

At my pregnancy clinic yesterday, I saw 7 women who were either pregnant or planning, and they were all going to be vaccinated at the recommendation of our team.

Dr. Kornbluth:  I wasn't thinking of figuring this out, but here's an important question. It'll impact, as we tell patients, get it when you can. Your patients who you haven't seen in a while, you say to them, "Did you get your flu vaccine yet because it's the season? You don't want to get flu and COVID and deal with that."

The patient says, "Well, I heard if you get a flu vaccine, you have to wait 14 days to get your COVID vaccine." This has come up. I say, "You're probably right. I'd probably rather you get the COVID vaccine if you get your hands on it. Defer pneumococcal vaccine, defer your flu vaccine." They are practical things that come up.

The other things patients bring up, besides misinformation, which we could talk about briefly, because they're going to turn to us for true information. Marla and I both are very passionate that it's our responsibilities.

The ones who are face‑to‑face with the patients, the patients who know us, trust us, and love us for all these years, that have the loudest voice and are going to be the strongest impression on them, and counter so much of the misinformation. Some of it honest, some of it malignant.

As you have more people get vaccinated, we're above several million people already in the United States, there are going to be people who have severe reactions. Anaphylaxis had a lot of original attention, but if you vaccinate a million people, the next week you're going to have 10 people die within an hour of their vaccine.

You take another million people control as a control, which we don't have, 10 more are going to die in any given hour. Anaphylactic reactions will happen. They're still extremely rare. The official recommendation now is, if you have a history of anaphylaxis, the sort of anaphylaxis that you know where your EpiPen is, or, this is the CDC list, any allergic reaction (this is going to come up with our Remicade patients, let's say) to any previous vaccine, or an infusible or injectable med, then you should be "watched." All it comes down to is the recommendation for an extra 15 minutes, or 30 minutes, as opposed to 15 minutes.

Patients are asking all the time now, "I had an allergic reaction to infliximab. I had an allergic reaction to my iron." The answer is, don't avoid the vaccine. There's very few scenarios where you're going to tell a patient, "Don't get the vaccine." The only one that's official, is if you were just getting over COVID. In fact, as you know, the trials excluded patients who are on immunosuppressives.

That's why we're looking for guidance. They did not exclude patients, and they did not test for baseline history of COVID, or baseline antibodies. The official recommendation, even if you had it, get the vaccine, because you're neutralizing antibodies, your native antibodies. We have no idea for how long they may be affected.

Just as patients are asking right now, "How long is the vaccine effective?" The answer is we just don't know. I tell everyone, anybody who gives you information with any degree of certitude, that's the person you can't believe. We have no idea of the long‑term effectiveness, the duration of this. There is a lot of misinformation.

We're going to post, beside the link to the CDC where they outline the different tiers, a very legitimate link. Mount Sinai, we get a daily update where they post this link about, at this point, 13 leading misconceptions or misinformation. Some of them which have a kernel of truth to them. It's really incumbent upon us to know what they are.

Marla, perhaps you could talk about the vaccines that are about to come next, which are probably, we have no inside information, AstraZeneca and J&J. Both of them are vaccines that have an adenovirus as a vector.

Dr. Dubinsky:  Correct.

Dr. Kornbluth:  Patients are worried, are they going to get an illness from the vaccine? If they're DNA vaccines, is this going to intercalate with their own DNA? These are important questions. What are you telling your patients about the upcoming adenovirus vaccines?

Dr. Dubinsky:  Again, I'm glad you asked because I was going to say I want to also remind our patients, speaking about medication, is that none of the mRNA, the Pfizer or the Moderna, it is not a live vaccine. The adenoviral vectors, which means the adenovirus is carrying the spike proteins that could deliver the protein, these are nonreplicating.

These are not viruses that are going to be replicating in itself. The fact that we're going to have 4, hopefully, depending on how AstraZeneca in the US goes. As you noted, J&J, they're both the similar mechanism. The difference between AstraZeneca and J&J is that J&J's only one dose. AstraZeneca is a two‑dose, just like Moderna and Pfizer.

The fact overall what I tell my patients and anybody who asks, I say the 4 vaccines that will have potential availability for which our patients will not be, hopefully sooner than later, will not exposed to any live virus.

We are advocating strongly that whatever vaccine of these 4 that you can get access to, and that comes in the line, we tell them that they are eligible to get them. We believe these to be safe and effective. It's important because patients have heard from us to avoid live vaccines and this is so new. The mRNA vaccine, what is that? Is that live? Is it not?

Reminding our patients that we are constantly advocating and continue to follow for the safety of these types of vaccines in IBD patients.

Dr. Kornbluth:  I agree with everything you say. We're all going to have to load up on template letters to say our patients have, whatever disease it is, that they have that might make them at risk, Crohn's and colitis so far are considered autoimmune diseases and they'll list it. CDC has 80 autoimmune diseases of which Crohn's and colitis are a part of.

Already we have the immune‑weakening drugs. That's important for us to know, because they're probably going to launch very soon. The other point, and this is probably going to be for our next webinar if we're not booted off this platform...

Dr. Dubinsky:  [laughs]

Dr. Kornbluth:  ...is what are we going to tell patients if J&J has an efficacy of 80 percent? Should they wait six months and get the 95% efficacy? The short answer is, there's still so much we don't know. We have to be humble about this. It's incumbent upon us, because the patients will often know before us, to stay up to date. Read the literature, go online.

You'll find more information probably early on in the New York Times mobile app, which is free every day, coronavirus. No information is being waited upon till we see publication. We get the trial results within hours, typically in the New York Times. Marla, thank you for having me once again.

Dr. Dubinsky:  Of course.

Dr. Kornbluth:  I don't know if we'll be doing this again, but this is such a fluid situation. We really need to stay on top of this.

Dr. Dubinsky:  I want to thank our viewers, let you know that I received my second dose on Monday, and so far so good. I'm excited. We've gotten almost 25,000 people vaccinated at Mount Sinai as of yesterday. This is a very exciting time. We will definitely be back to tell you more as this situation evolves, as it relates to our patients with IBD and their medications. Thank you.

Dr. Kornbluth:  Thank you very much.

Reference:

Siegel CA, Melmed GY, McGovern DPB, et al. SARS-CoV-2 vaccination for patients with inflammatory bowel diseases: recommendations from an international consensus meeting. Gut. 2021; 0(0):1-6. Epub

 

MORE RESOURCES

 

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-20/02-COVID-Dooling.pdf

           CDC slides outlining the rationale, methods and data supporting the CDC allocation guidance.

 

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x

Narrative review of the literature by the CDC Advisory Committee on Immunization Practices (ACIP) leading to the development of the allocation guidelines

 

https://www.newsguardtech.com/special-report-top-covid-19-vaccine-myths/

Website tracks and presents evidence to combat myths and misinformation

regarding COVID-19.