COVID-19 and Rheumatology

COVID-19 and Rheumatology

Disclosures: Disclosures: Calabrese reports no relevant financial disclosures. Winthrop reports research/consulting relationships with Eli Lilly, GlaxoSmithKline, Pfizer and Regeneron.
January 13, 2021
5 min read

Navigating COVID-19 vaccine hesitancy: What are you telling your patients?

Disclosures: Disclosures: Calabrese reports no relevant financial disclosures. Winthrop reports research/consulting relationships with Eli Lilly, GlaxoSmithKline, Pfizer and Regeneron.
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With two COVID-19 vaccines from Moderna and Pfizer-BioNTech now in circulation and individuals nationwide receiving their initial doses, patients and providers have questions — a lot of questions.

In a search for answers, Healio Rheumatology sat down with Cassandra Calabrese, DO, of the department of rheumatologic and immunologic disease at the Cleveland Clinic, and Kevin L. Winthrop, MD, MPH, of the Oregon Health & Science University. Both are leading voices on vaccination and immunology as they pertain to rheumatic and autoimmune diseases.

“Our patients are very health-conscious, so they are often interested in these details, yes. But even if they are not, I always ask them about the vaccine at the end of a visit if we had not addressed it yet: ‘Has anyone talked to you about the COVID-19 vaccine?’,” Cassandra Calabrese told Healio Rheumatology. Source: Adobe Stock

Topics at hand include possible drug- or disease-related effects on the safety or efficacy of the vaccines, potential differences between the Moderna and Pfizer-BioNTech products that are currently available and the accelerated development process the vaccines underwent.

Q. Many people seem to be concerned about the speed with which the vaccines have been developed. Could you address this?

Winthrop: The hesitancy is somewhat understandable because these are new or possibly unfamiliar vaccine platforms. I am trying to reassure my patients and friends that even though the speed of these development programs is unprecedented, if you look at the types of steps that were taken, they are the same steps that would be taken in any vaccine development program, from animal studies to early human volunteers, through phase 1, 2 and 3 studies of huge magnitude. They just did them more quickly because it’s a pandemic.

Kevin L. Winthrop

There is really nothing different here in terms of what we know about vaccine safety. I tell my patients that the right and proper science has been used, and to not be put off by the speed. That is an important message to get out to people.

Calabrese: We see that speed as a positive thing. It is a miracle of science. We also stress to our patients that there were no shortcuts taken in the development process, they passed rigorous testing and licensure procedures like any other vaccine. We tell them that we are learning more about these vaccines every day, and that, so far as we can tell now, they work, and they are safe.

Q. Should patients be concerned about any differences between the Pfizer-BioNTech and Moderna products?

Calabrese: I consider them together, as they are both mRNA vaccines made with the same technology, and patients with autoimmune and rheumatologic diseases were largely excluded from the clinical trials. Pfizer included a handful of patients with a history of rheumatic disease, but presumably not on immunosuppression. That said, we see no major safety concerns for our patients, however, many studies are being undertaken to investigate safety and risk of disease flare after administering the COVID-19 vaccine in rheumatic disease patients.

Cassandra Calabrese

If there is any disease-specific issue to consider, there may be some theoretical concerns in lupus patients with their interferon signature. However, the mRNA product in the vaccine is heavily modified to not trigger the immune system in that way. We have ongoing studies of this at the Cleveland Clinic. Overall, the benefits outweigh the potential risks.

Q. Are you getting deep into the weeds about the mechanism of action with patients?

Calabrese: Our patients are very health-conscious, so they are often interested in these details, yes. But even if they are not, I always ask them about the vaccine at the end of a visit if we had not addressed it yet: “Has anyone talked to you about the COVID-19 vaccine?” This creates an opportunity for us to discuss. It is important for patients to hear the facts and recommendations from us because there is so much wacko information out there, just the craziest stuff from all types of media. We have long-term relationships with our patients, so we are trusted sources for them. When we tell them about how the vaccine works and that it is safe, they tend to believe us.

Q. Concerns from patients are understandable. Are you hearing concerns from other providers?

Calabrese: This may be part of overall hesitancy about vaccines. There are some troubling numbers about slow uptake or resistance to vaccines among people who work in nursing homes and acute care facilities. Fortunately, we have not seen much of this among rheumatologists. That said, I am sure some of our colleagues want to wait until other people get vaccinated due to fear that there is something, safety-wise, that we do not know yet because it was authorized so quickly. We just have to continuously remind patients and providers that we feel strongly that vaccines are safe and have been around for a long time.

Winthrop: Let me add to that several recent surveys suggesting a significant proportion of medical students and health care personnel at certain institutions are not interested in being vaccinated. Also, we are seeing that there are outbreaks at health care institutions, even including transmission from health care workers to patients. Think of the liability involved of a health care worker who refuses vaccination and then transmits disease to a patient. The asymptomatic transmission exhibited by this virus is extremely challenging, such that many transmitters would not otherwise know they are at risk to those around them.

But now that we have vaccines, we have to address the question of whether workplaces, hospitals or other health care institutions will be able to mandate vaccination. Or, if there is a health care worker who refuses vaccination, to reassign that person to a different job not involving patient care. There are many questions to be hashed out in the near future.

Q. Are there any drug-specific issues to be considered?

Calabrese: The biggest concern is with drugs like rituximab (Rituxan, Genentech) that deplete B cells. If you get a shot within the 6-month period that B cells are depleted after a dose of rituximab, it may not do much. So, as rheumatologists, we really have to consider the timing of this. We need to ensure that our patients can be safely vaccinated without putting them at risk for life-threatening complications from vasculitis because they have not taken their medication. I am on the American College of Rheumatology COVID-19 vaccine task force, and we will be considering issues like this.

Winthrop: I would add that there are theoretical issues associated with other mechanisms of action. For example, it may be beneficial to stop a JAK inhibitor or methotrexate for a few weeks after vaccination, but that is not certain yet. We are trying to extrapolate from other vaccines. We also need to consider the timing of other infusibles and injectables. The fact that these vaccines are two doses definitely complicates the timing of stopping DMARDs in order to potentially enhance vaccine response.

Q. Do you envision that a COVID-19 vaccine will require a yearly dose, like a flu shot?

Calabrese: We don’t know yet. There will be ongoing analysis of trial data and beyond to make this determination.

Q. Do some patients still have concerns that the virus can be transmitted after they have received the vaccination?

Winthrop: That is more of a scientific or public health concern. Most patients seem to understand that if they get protected, they are protected. But we are trying to get the message out that until further notice, it is important to continue to wear masks and wash your hands.

Q. What other questions do you get from patients?

Winthrop: Patients want to know when they are getting vaccinated, or where they are on “the list.” Unfortunately, there is no “list,” to my knowledge. We have ideas about who should go first — health care workers, first responders, etc. — but there are some differences in guidance at the federal level, and the states are all doing their own thing at the moment. One issue is that we do not yet have enough vaccine for everyone, so there is a need to prioritize. That is complicated, confusing, sometimes controversial and makes it more difficult to distribute vaccine quickly.

While it would be nice to blow through that first tier of essential personnel, as we mentioned before, unfortunately not everyone is getting vaccinated. I think there is a major sense of waiting for the federal administration to change so that a more coordinated and efficient approach can be pursued with regard to vaccine distribution. Ultimately, we are waiting on more vaccine products to be on the market. When we have three or four or more products available, we will be able to distribute them more widely and do this thing on a mass level without being complicated by a need to prioritize limited supply.

For more information:

Cassandra Calabrese, DO, can be reached at 9500 Euclid Ave., Desk A50, Cleveland, OH 44195.

Kevin L. Winthrop, MD, can be reached at 270 Southwest Pavilion Loop OHSU Physicians Pavilion, Suite 320, Portland, OR 97239.