Issue: July 2020
Source/Disclosures
Source: Garcia-Serrano C, et al. BMC Public Health. 2020; May 19;20(1):713. doi:10.1186/s12889-020-08850-y.
Gurvits GE, et al. Postgrad Med J. 2017; Jun;93(1100):333-337. doi:10.1136/postgradmedj-2016-134266.
Melmed GY, et al. Am J Gastroenterol. 2010; Jan;105(1):148-54. doi:10.1038/ajg.2009.523.
Wasan SK, et al. Inflamm Bowel Dis. 2011; Dec;17(12):2536-40. doi:10.1002/ibd.21667.
Disclosures: Cassandra Calabrese, Caldera, Melmed, Offit and Patty-Resk report no relevant financial disclosures. Leonard Calabrese reports serving as an investigator and a consultant to Horizon Pharmaceuticals. Winthrop reports personal fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, GlaxoSmithKline, Pfizer, Roche and UCB, as well as grants from Bristol-Myers Squibb.
July 17, 2020
12 min read
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‘This is the world without one vaccine:’ Addressing vaccine-hesitancy in IBD

Issue: July 2020
Source/Disclosures
Source: Garcia-Serrano C, et al. BMC Public Health. 2020; May 19;20(1):713. doi:10.1186/s12889-020-08850-y.
Gurvits GE, et al. Postgrad Med J. 2017; Jun;93(1100):333-337. doi:10.1136/postgradmedj-2016-134266.
Melmed GY, et al. Am J Gastroenterol. 2010; Jan;105(1):148-54. doi:10.1038/ajg.2009.523.
Wasan SK, et al. Inflamm Bowel Dis. 2011; Dec;17(12):2536-40. doi:10.1002/ibd.21667.
Disclosures: Cassandra Calabrese, Caldera, Melmed, Offit and Patty-Resk report no relevant financial disclosures. Leonard Calabrese reports serving as an investigator and a consultant to Horizon Pharmaceuticals. Winthrop reports personal fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, GlaxoSmithKline, Pfizer, Roche and UCB, as well as grants from Bristol-Myers Squibb.
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As far as hot-button health care topics go, it is hard to top vaccines. Even dropped into a casual conversation, the idea itself in its various iterations can cause tension and divisiveness.

It follows, then, that talking to vaccine-hesitant patients about the topic can present significant challenges for gastroenterologists treating inflammatory bowel disease. However, the conversation is necessary, and may need to take place at every visit.

Gil Y. Melmed, MD, of Cedars Sinai, discussed the need for gastroenterologists to discuss recommended vaccinations at every visit, especially now as we enter flu season amid another pandemic. Some protection is better than none, especially with COVID risks this year, he said.
Gil Y. Melmed, MD, of Cedars Sinai, discussed the need for gastroenterologists to discuss recommended vaccinations at every visit, especially now as we enter flu season amid another pandemic. Some protection is better than none, especially with COVID risks this year, he said.
Source: Cedars Sinai.

“I personally have a hard stop in my templated note that forces me to address vaccinations,” Gil Y. Melmed, MD, director of clinical IBD at Cedars-Sinai Medical Center, said in an interview. “It takes 30 seconds. It doesn’t take long, but it’s more impactful if patients hear the message directly from their doctor.”

The discussion needs to happen because patients with IBD are susceptible to many infections — a concern often exacerbated by immunosuppressive therapy — and therefore require several immunizations: influenza, pneumococcus, a tetanus booster every 10 years, hepatitis A, shingles, meningococcus and HPV.

Beyond the recommendations for immunizations, the next major hurdle is the to address information and misinformation available to today’s patient. It is up to the physician to set the record straight.

“Some people are philosophically opposed to vaccines and we may not ever convince them. But sometimes people are misinformed. They believe it will make their disease worse. They think it’s contraindicated,” Melmed said. “There are a lot of opportunities if you just ask the question: why didn’t you get the flu shot? For those who aren’t getting their flu shots, identifying reasons for lack of vaccination can open a window for discussion and education.”

Some vaccine-hesitant patients may be swayed by big data. Others are more likely to be convinced by personal anecdotes.

Cathy Patty-Resk, MSN, RN-BC, CPNP-BC
Cathy Patty-Resk

It is important to understand that not everyone who opts out of vaccination, or who chooses not to vaccinate their child, is an anti-vaccine advocate, according to Cathy Patty-Resk, MSN, RN-BC, CPNP-BC, a pediatric nurse practitioner at Children’s Hospital of Michigan. “For many parents, it is just another parenting belief and they are counting on herd immunity to protect their children,” she said.

In fact, Patty-Resk suggested that most patients who are vaccine-hesitant are simply people who have heard a few negative reports in the mainstream media and need more information.

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Explaining Real Risks

For Paul A. Offit, MD, director of the Vaccine Education Center and an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, it is important to separate fact from fiction when it comes to risks associated with vaccination. “We need to tell our patients that, as with any medical or preventive therapy, in addition to the many benefits, there are risks associated with vaccines,” he said.

Paul A. Offit, MD
Paul A. Offit

Ultimately, separating the true risks from the false risks can accomplish two goals: it can validate the concerns that patients may have, but, simultaneously, assuage those concerns by helping them understand that the actual risks they undertake in getting vaccinated are usually mild and transient.

For example, injection site pain can occur, along with fevers, chills and headaches, or sluggishness and achy joints. Offit noted that letting patients know that most of this will go away in a day or two is an important message.

“Can vaccines also cause serious side effects?” Offit said. “Yes, of course. We should tell our patients about those events, as well, and address their concerns head-on.”

For example, the influenza vaccine, in extremely rare cases, can cause Guillain-Barré syndrome. In even more rare cases, it has caused narcolepsy, but never in the U.S., according to Offit.

Also in the rare-but-serious category are allergies to vaccines — usually the allergy is to the gelatin, which is added to some vaccines as a type of preservative — which Offit suggested can occur in one in 1.4 million doses. “The measles vaccine can also cause thrombocytopenia, but even this comes with no permanent harm,” Offit said.

The issue, for Offit, is that many of the people who strongly oppose vaccines never address these real risks. “They mention autism, developmental disorders, chronic fatigue syndrome, ADHD,” he said. “None of this is true, of course.”

Yet the risks for infection are very real for patients with IBD and that is important for gastroenterologists to convey.

Freddy Caldera, DO, MS, assistant professor of medicine in the division of gastroenterology and hepatology at the University of Wisconsin School of Medicine and Public Health, said putting the risks for immunosuppressive therapies and infections into perspective helps him increase uptake.

Freddy Caldera, DO, MS
Freddy Caldera

“We talk about lymphoma a lot, we talk about risks of cancer” with IBD therapies, he said. “When we put the risk of infection in perspective where the risk of someone developing a serious infection where they are hospitalized is much higher than developing lymphoma, that has helped me. By putting the risk of infection in perspective, it has increased my ability to get higher vaccination rates for patients.”

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Once the risks have been explained, the next best thing a gastroenterologist can do is prepare for the questions they are likely to face about the vaccines.

Understanding Concerns

For a decade or more, studies on vaccine compliance of patients with IBD confirmed that vaccination uptake in this population is not where it should be.

Most recently, a study out of Spain showed none of the vaccines exceeded 65% compliance among more than 1,700 patients surveyed.

Melmed, who conducted a similar study a decade ago, said, “This study has been repeated multiple times across the United States, around the world in various IBD populations as well as different health care settings — population based studies, tertiary care centers, primary care — and the findings unfortunately continue to show that in patients with IBD, the uptake of various recommended vaccines are generally poor and continue to miss the mark.”

Patients’ concerns about and reasons for not getting their recommended immunizations vary from fears about causing an IBD flare to general mistrust of vaccines. Gastroenterologists, then, may need to do a better job of discussing these vaccinations with their patients.

“Most commonly, I find myself talking to patients about the flu shot because it’s so ubiquitous and everyone needs it,” Melmed said. “Also, there is a lot of misperception out there.”

Most of the experts interviewed also said refusal of one vaccine, like influenza, does not mean the patient will deny others.

“Just because someone says no to the influenza vaccine, even if they continue to say no, they are still open to talking about other vaccines,” Caldera said. “When I started making these efforts, I always assumed if they said no to one, they would say no to all. But it’s not all or none.”

The other concern often expressed by patients is that immunization is not as effective when they are on immunosuppressive medication.

“Some protection is better than none. Vaccines may not work as well in people who are immunocompromised but that doesn’t mean we shouldn’t give them,” Melmed said. “The flu shot isn’t 100% effective and it doesn’t decrease the flu in everybody, but it may help someone who gets the flu to have a milder course. Even though it isn’t perfect, some protection is better than none, especially with COVID risks this year.”

Responsibility, Procedure

Despite the knowledge that patients with IBD are at greater risk for infection yet are not being compliant in their immunizations, there remains a question of who should deliver that protection.

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“As gastroenterologists, we don’t necessarily view preventive health as in our domain,” Melmed said. “I’m the one prescribing the medications that puts the patient at risk, shouldn’t it be my responsibility to educate them about their risks?”

In 2011, Wasan et al showed that 52% of GIs asked patients with IBD their immunization history most or all of the time but 64% believed the primary care provider should determine which vaccines to give and 83% put the responsibility of delivering the vaccinations on the primary care provider.

“My personal belief is because we provide the immunosuppression, we really should own immunization,” Caldera said.

Primary care, they agree, requires additional education on which vaccines are safe and which are contraindicated. In a 2017 study, only 2.5% of primary care providers always recommended the correct vaccines to patients with IBD; up to 23% incorrectly recommended live vaccines to patients taking immunosuppressants.

“Primary care providers who typically do take care of preventive health aspects are not necessarily aware or are not comfortable with IBD medications. They may not know the medications put patients at higher risk. They may be afraid to give vaccines that may be harmful, may cause a flare or may be contraindicated,” Melmed said. “There is a knowledge gap and opportunity for education among primary care providers, which unfortunately puts a lot of the burden on the gastroenterologist to at least to convey recommendations and educate patients and primary care providers.”

Caldera added that younger patients with IBD are less likely to see their primary care physician regularly and may look to the gastroenterologist for the bulk of their care.

“As providers, we are asked to do a lot of things, so this can be daunting to take this on as an additional responsibility,” he said. “Maybe a good place to start is with the younger patients who are unlikely to see another physician. In those patients you can make a difference.”

At a minimum, gastroenterologists should bring up vaccinations at every visit, Melmed and Caldera agreed, and this can be done in various methods.

Melmed has his hard stop in his notes.

“That forces me to address vaccination issues with patients. At this time of year, if I’m seeing patients who I may not see for another 3 to 6 months, I’m bringing up the flu shot with every patient,” he said. “This is a highly effective reminder for me as a provider to bring it up. But it doesn’t have to be that the physician; it can be a nursing protocol, or it can be brought up by anybody the patient has an encounter with – but it should be built in to the processes of the clinic rather than relying on someone remembering to do so.”

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In Caldera’s clinic, they can deliver some vaccinations like the flu in-house. Their procedure has the medical assistant address immunization status and, if the patient is interested, they receive the vaccination at that visit. If they are hesitant, Caldera addresses it with them.

“I talk about the risks of not being immunized. The fact that they are immunosuppressed. The fact that there are studies showing they are at increased risk for influenza compared to healthy controls,” Caldera said. “The majority of the time, with education, I can get most people immunized. Maybe not the first time they come to clinic, but with a patient we have built a rapport, it becomes easier to do it.”

That rapport also comes into play when a patient may be off their immunosuppressive therapy and could catch up on their live vaccines.

“We have to recognize it’s not just the new patient consultation where we have more time. Everybody is going through flu season every year and the flu vaccine changes so everybody needs a flu shot every year. Then people get older, so they age into the risk categories for other preventable infections like shingles,” Melmed said.

In a joint interview about framing the conversation with vaccine-hesitant patients, Leonard H. Calabrese, DO, chief medical editor of our sister publication, Healio Rheumatology, and director of the RJ Fasenmyer Center for Clinical Immunology at the Cleveland Clinic, and Cassandra Calabrese, DO, of the Cleveland Clinic, repeatedly used words like “respect,” “empathy” and “trust.”

Leonard H. Calabrese, DO
Leonard H. Calabrese

“The interpersonal relationship we build with a patient over months and years is a very powerful tool,” Leonard Calabrese said. “If you use it wisely, and do not bully people, you can then bring some reason to the medical decision-making.”

Data, Anecdote and Bargaining

Once it has been established that “something” needs to be said every time, the next consideration is exactly what to say.

Kevin L. Winthrop, MD
Kevin L. Winthrop

“I will pull data from the CDC showing efficacy, I will pull data showing that the particular vaccine has never caused autism, I will show them studies with 10,000 patients,” Kevin L. Winthrop, MD, of Oregon Health Sciences University, told Healio Gastroenterology. He acknowledged, however, that sometimes the data can be overwhelming or incomprehensible to some patients.

For Patty-Resk, it can be effective to hit hard, and hit home. “I will say to a parent, ‘Your child could die if they get the flu or any of the other vaccine-preventable diseases,’” she said.

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Cassandra Calabrese, DO
Cassandra Calabrese

Cassandra Calabrese suggested that when the family member of a patient is present, it offers another opportunity. “If the patient is resistant but their family member is not, or vice versa, I can use one to encourage the other, and, often, both will leave my office convinced to get their shot,” she said.

Most patients are aware that young children and older adults are more vulnerable to influenza and other infections. “I use that knowledge and try to explain that when you get a flu shot, you are not just protecting yourself, but you are protecting your more vulnerable loved ones, as well,” she said. “I capitalize on the fact that patients feel a sense of love and responsibility to those around them.”

Perhaps the hardest aspect of being a health care provider is falling short in negotiating with a patient, and the patient ultimately refuses to get their shots.

“I am not going to let a parent’s beliefs affect my relationship with them or their child, even if it will make my job riskier and more difficult,” Patty-Resk said. “We cannot refuse to treat a patient because of their beliefs.”

Risk of Two Pandemics

Melmed and Caldera expressed immediate concerns about the unknowns of dual influenza and COVID-19 infection and the role vaccine hesitancy could play in the rise of a secondary pandemic this fall.

“With the current COVID situation, we don’t know what the implications will be for getting the flu and COVID at the same time,” Melmed said. “Our patients, specifically, who are immunosuppressed, are at a higher risk for complications from the flu if they get it. They are more likely to get pneumonia. Providing them some protection against the flu and pneumonia with vaccinations needs to be addressed now because we don’t know what this coming flu season is going to look like in the setting of COVID.”

Caldera said the burden of responsibility is more difficult to balance in a time when patients are not necessarily seeing their primary care provider regularly.

“People will have less visits with COVID,” he said. “Our health system cannot deal with the COVID pandemic and a potential influenza pandemic, due to low uptake of the influenza vaccine.”

Give explicit instructions to patients to get their flu shot when they pick up their IBD medications, he suggested.

“With COVID, vaccines become more important. This is the world without one vaccine,” Caldera said. “When the COVID vaccine finally does come out, we have to make sure we have it in clinic and ensure high uptake of the vaccine.”

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Combatting Misinformation

For Leonard Calabrese, the individual conversations are part of a larger picture.

“We are not doing a very good job, as a specialty and as a country, in informing people that vaccines are necessary, and that they are safe and effective,” he said. “There has to be a commitment that we are going to be part of this health care team that is going to bring protective vaccines not only to a vulnerable segment of the patient population ... but to as many people as possible.”

Patty-Resk urged clinicians to support restrictions on social media that spread “horrific lies” about community health issues. “As providers, we should be backing legislative mandates for vaccination of all school children or even all children,” she said.

A number of government and nongovernment organizations, from the American Academy of Pediatrics to Voices For Vaccines, are working for the cause. In IBD specifically, the Crohn’s and Colitis Foundation and other organizations provide materials to educate patients.

Despite the good work being done by physicians and researchers, there are still significant hurdles to clear, according to Winthrop. “Vaccine resistance reflects a broader trend in our society in which people in important places lie and spread falsehoods,” he said. “There is just so much lying going on in our society. What is happening with vaccines is part and parcel of that.”

Winthrop stressed that it is not just poorly educated people who are vaccine-hesitant. “It makes me sad when college-educated people choose not to get vaccinated, or choose not to vaccinate their kids,” he said. “They are putting themselves or their children above everyone else. This not something we should be able to choose. This is something for the public good.”

In today’s pandemic climate, vaccine hesitancy may be an even bigger hurdle in the next few months.

“People are starting to think about and talk about vaccinations [for COVID] — what they might look like and how that would affect patients with IBD. Also, the anti-vaxxers are already starting to beat their drums about a COVID vaccine,” Melmed said. “Now is the time to be very clear about what the medical recommendations are.”